News

Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

Autolus | November 8, 2024

AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy)
Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALL
Conference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release

LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the U.S. Food and Drug Administration (FDA) has granted marketing approval for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

Adaptimmune and Galapagos Sign Clinical Collaboration Agreement with an Option to Exclusively License Adaptimmune's TCR T-cell Therapy Candidate, uza-cel, in Head & Neck Cancer and Potential Future Solid Tumor Indications

Adaptimmune | May 30, 2024

Adaptimmune and Galapagos to conduct clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation MAGE-A4 TCR T-cell therapy) produced on Galapagos' decentralized manufacturing platform in patients with head & neck cancer
Uza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune's centralized manufacturing platform
Initial in vitro testing of uza-cel produced on Galapagos' decentralized manufacturing platform has shown encouraging data that support further clinical development
Adaptimmune to receive initial payments of $100 million, comprising $70 million upfront and $30 million of R&D funding, option exercise fees of up to $100 million, additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales
Galapagos has been granted an option to exclusively license uza-cel for global development and commercialization in head & neck cancer, and potential future solid tumor cancer indications

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - May 30, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), and Galapagos NV (NA: GLPG) (NASDAQ: GLPG) announced today that they have entered into a clinical collaboration agreement with an option to exclusively license Adaptimmune's next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos' decentralized cell manufacturing platform.

Corvus Pharmaceuticals Announces Pricing of $30.6 Million Registered Direct Offering

Corvus | May 2, 2024

BURLINGAME, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today announced that it has entered into a securities purchase agreement with new and existing investors to raise approximately $30.6 million dollars in aggregate gross proceeds through the sale of shares of its common stock, par value $0.0001 per share (the “Common Stock”) and pre-funded warrants to purchase Common Stock in lieu thereof (the “Pre-Funded Warrants”), and accompanying common warrants to purchase Common Stock (or Pre-Funded warrants in lieu thereof) (the “Common Warrants,” and together with the Common Stock and Pre-Funded Warrants, the “Securities”), excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Common Warrants and before deducting offering expenses.

The offering includes participation from health-care dedicated investors including Point72, Samlyn Capital, Armistice Capital, OrbiMed, Puissance Capital and Altamont Pharmaceutical Holdings, and other existing investors including Richard Miller, the Company’s chief executive officer.

Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical For $2.4 Billion

Deciphera | April 29, 2024

Deciphera Shareholders to Receive $25.60 per Share in Cash
Deciphera’s Kinase Inhibitor Expertise and Established Commercialization Platform in Key Markets Will Reinforce ONO Pharmaceutical’s Pipeline and Accelerate Global Reach

WALTHAM, Mass.--(BUSINESS WIRE)--Apr. 29, 2024-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced that it has entered into a definitive merger agreement with ONO Pharmaceutical Co., Ltd. (ONO), under which ONO will acquire all outstanding shares of Deciphera common stock for $25.60 per share in cash through a tender offer followed by a merger of Deciphera with a wholly-owned subsidiary of ONO (the “Acquisition”), for a total equity value of $2.4 billion. The boards of directors of both companies have unanimously approved the transaction.

Akero Therapeutics Reports Statistically Significant Histological Improvements at Week 96 in Phase 2b HARMONY Study

Akero | March 4, 2024

50mg (75%, p<0.001) and 28mg (46%, p=0.07) EFX groups demonstrated ≥1 stage improvement in fibrosis without worsening of MASH, approximately three- and two-fold the placebo rate (24%)
50mg (36%, p<0.01) and 28mg (31%, p<0.01) EFX groups demonstrated ≥2 stage improvement in fibrosis without worsening of MASH, more than 10-fold the placebo rate (3%)
EFX-treated patients experienced statistically significant improvements on nearly all histological endpoints by ITT analysis as well as the primary analysis of patients with week 96 biopsies

SOUTH SAN FRANCISCO, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today released preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3). The study previously met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups, compared to 20% for the placebo arm. At week 96, the response rates on this endpoint increased to 75% (p<0.001) for 50mg EFX and 46% (p=0.07) for 28mg EFX, compared to 24% for placebo.

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Iovance | February 16, 2024

MTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy
AMTAGVI deploys patient-specific immune cells that recognize and fight cancer

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics

CymaBay | February 12, 2024

Gilead Adds Seladelpar to Portfolio, a PPARδ Agonist for the Treatment of Primary Biliary Cholangitis (PBC) with FDA Priority Review and Anticipated U.S. Approval in Third Quarter of 2024
Seladelpar Phase 3 Data Demonstrates a Best-in-Disease Profile for Second-Line PBC
Acquisition Expands Gilead’s Long-Standing Commitment to Patients with Liver Diseases

FOSTER CITY, Calif. & NEWARK, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced today a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion. The addition of CymaBay’s investigational lead product candidate, seladelpar for the treatment of primary biliary cholangitis (PBC) including pruritus, complements Gilead’s existing liver portfolio and aligns with its long-standing commitment to bringing transformational medicines to patients.

BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs

Autolus | February 8, 2024

Strategic alliance leverages manufacturing and commercial infrastructure as well as technology with the aim to advance both companies’ autologous CAR-T programs towards market, pending market authorization

BioNTech secures the right to utilize Autolus’ manufacturing capacity in a cost-efficient set-up to accelerate the development of BNT211 into pivotal trials in CLDN6+ tumors
BioNTech to support launch and expansion of development program of Autolus’ lead cell therapy candidate obe-cel and will receive a royalty on net sales
BioNTech has co-commercialization options for Autolus’ AUTO1/22 and AUTO6NG programs
BioNTech has the option to access a suite of Autolus target binders and cell programming technologies to support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates
BioNTech agrees to invest $200 million in Autolus

MAINZ, Germany and LONDON, Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc (Nasdaq: AUTL, “Autolus”), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

MeiraGTx Announces Asset Purchase Agreement Involving its AAV-RPGR Collaboration for up to $415 million

MeiraGTx | December 21, 2023

LONDON and NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced an asset purchase agreement with Janssen Pharmaceuticals, Inc. (J&J), a Johnson & Johnson company, for the remaining interests in bota-vec for the treatment of XLRP, as well as a commercial supply agreement and a technology transfer agreement for bota-vec manufacturing.

“We are very happy to announce the execution of the agreements related to bota-vec for the treatment of XLRP, which provide us with significant near-term cash as well as cash upon potential approval and commercialization of this important gene therapy, and additional revenue from the commercial manufacture of bota-vec,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “The initial $130 million upfront and near-term milestone payments, combined with the $30 million investment we received from Sanofi in October, increases our cash runway to mid-2026, without including the additional $285 million in potential payments associated with this transaction.”

Altamont Pharma Announces Promotion of Rhozel Ocampo to Senior Vice President of Finance & Risk Management

Altamont Pharma | December 21, 2023

Dallas, Texas based Altamont Pharmaceutical Holdings, LLC (“Altamont Pharma”) today announced the promotion of Rhozel Ocampo to Senior Vice President of Finance & Risk Management. Ms. Ocampo has served as Vice President of Finance & Risk Management for several years and has been with Altamont Pharma since 2018.

“Rhozel brings a deep understanding of financial strategy, capital raising for our portfolio companies, corporate strategy, operations and risk management functions in her expanded role as Altamont Pharma’s portfolio continues to increase in value,” said Mark Pearson, Founder and Chief Executive Officer of Altamont Pharma.

Altamont Pharma has had a successful year in a very turbulent market for biotech companies and the overall life sciences industry. Several of Altamont Pharma’s portfolio companies have announced being acquired this year, such as Mirati Therapeutics, Inc. (NASDAQ: MRTX) to be acquired by Bristol-Myers Squibb Company (NYSE: BMY) for up to $5.8 billion, Orchard Therapeutics, Inc. (NASDAQ: ORTX) to be acquired by Kyowa Kirin for up to $477.6 million, and Iveric Bio, Inc. acquired by Astellas Pharma for $5.9 billion, along with several Altamont Pharma portfolio companies receiving FDA approval this year for their therapeutics. In addition, Cessation Therapeutics, Inc., a firm co-founded, incubated and financed out of Altamont Pharma and JDH Investment Management, LLC, received FDA approval to commence clinical trials along with receiving a Fast Track designation for its CSX-1004 for the prevention of fentanyl and fentanyl analog overdose. Cessation Therapeutics, Inc. also received a large grant from the NIDA, a division of the NIH, to support the development of a subcutaneous formulation of Cessation’s CSX-1004 SQ.

About Altamont Pharmaceutical Holdings, LLC

Altamont Pharma is a biotech investment firm based in Dallas, Texas focusing on investments in private biotech startup companies, undervalued small to mid-cap publicly traded biotech companies, incubating startup biotech companies by licensing promising technologies from world-renowned research institutes and universities, as well as partnering with large pharma companies around the world. Altamont’s philosophy is to invest long-term and in the vision of the entrepreneurs and scientists striving to cure life threatening diseases and reduce the effects of chronic disease. For more information, visit www.altamontpharma.com.

Ardelyx Reports Third Quarter 2023 Financial Results and Updates 2023 U.S. IBSRELA® Net Sales Revenue Guidance

Ardelyx | November 1, 2023

WALTHAM, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

“Ardelyx is effectively advancing on all fronts with clear focus, evidenced by the continued strong performance of IBSRELA as well as the approval and commercial launch of XPHOZAH,” said Mike Raab, president and chief executive officer. “Demonstrating consistent, quarter-over-quarter growth of IBSRELA prescriptions during the third quarter, we achieved a 22 percent increase in net sales revenue. We continue to see an increase in new and repeat writers, as well as new and refill prescriptions increasing from established writers at a steady, meaningful trajectory. We have raised our full year U.S. net sales revenue guidance for IBSRELA, reflecting the important benefit this product is offering to patients. In addition, on October 17, we received our long sought after FDA approval of XPHOZAH. Our team is in the field and launch is underway. We anticipate having product in channel in early November.”

Cessation Therapeutics Receives FDA Fast Track Designation for CSX-1004 for Prevention of Fentanyl and Fentanyl Analog Overdose

Cessation | October 31, 2023

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Cessation Therapeutics, Inc. (“Cessation”), a clinical-stage biotechnology company advancing biologics that target substances of abuse, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CSX-1004, an investigational therapy for prevention of fentanyl-related overdose. CSX-1004 is a human IgG1 monoclonal antibody specific for fentanyl and fentanyl analogs and works by sequestering fentanyl molecules as they enter the bloodstream, effectively neutralizing them in the blood before they reach the brain and preventing them from exerting their harmful effects.

Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an investigational product can reach the market expeditiously. Features of Fast Track designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

Deciphera Pharmaceuticals Announces Positive Top-line Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Updated Results from Phase 1/2 Study of Vimseltinib in TGCT

Deciphera | October 30, 2023

WALTHAM, Mass.--(BUSINESS WIRE)--Oct. 30, 2023-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced positive top-line results from the MOTION pivotal Phase 3 study of vimseltinib in patients with TGCT not amenable to surgery. Vimseltinib is the Company’s investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R.

MeiraGTx Announces $30 Million Strategic Investment from Sanofi; Company Pursuing Multiple Additional Strategic Opportunities

MeiraGTx | October 30, 2023

LONDON and NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced strategic updates including that Sanofi has made a $30 million strategic investment in the Company through the purchase of 4.0 million ordinary shares at a price of $7.50 per share.

Cessation Therapeutics Awarded $14.8 Million Grant from the National Institute of Drug Abuse to Develop Novel Formulation of Anti-Fentanyl Monoclonal Antibody

Cessation | October 19, 2023

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Cessation Therapeutics, Inc. (“Cessation), a clinical-stage biotechnology company advancing biologics that target substances of abuse, today announced that it has been awarded an additional grant from the National Institute on Drug Abuse (NIDA, a division of the National Institutes of Health) to support development of a subcutaneous formulation of its anti-fentanyl mAb, CSX-1004 SQ. The new grant (UG3DA058544) is part of a multi-year award expected to total $14.8 million given to Cessation and McLean Hospital, a member of Mass General Brigham.

CSX-1004 is a human IgG1 monoclonal antibody specific for fentanyl and fentanyl analogs and works by sequestering fentanyl molecules as they enter the bloodstream, effectively neutralizing them in the blood before they reach the brain and preventing them from exerting their harmful effects. Through different delivery methods, the platform can be optimized to potentially protect against overdose, reverse overdose, and treat fentanyl-related opioid use disorder (OUD).

FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor

Ardelyx | October 17, 2023

WALTHAM, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has approved XPHOZAH® (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.

Bristol Myers Squibb buys Mirati for up to $5.8B as I-O giant branches out into targeted therapy for cancer

Fierce Pharma | Mirati | October 9, 2023

After years serving as a rumored target of Big Pharma M&A, Mirati Therapeutics has finally made its sale a reality. The buyer, Bristol Myers Squibb, will pay up to $5.8 billion for the California-based cancer drug developer, the two companies said Sunday. The price marks a 52% premium to a 30-day average of Mirati’s stock before a Bloomberg report of a potential takeover boosted the company’s market performance.

Through the acquisition, BMS will gain FDA-approved non-small cell lung cancer (NSCLC) drug Krazati, which the companies billed as the best-in-class KRAS G12C inhibitor.

On top of the current equity value of $4.8 billion, the deal also includes a non-tradeable contingent value right term. It promises to pay Mirati shareholders $1 billion if the FDA accepts an application for the company’s pipeline drug MRTX1719 for NSCLC in patients who’ve received no more than two prior lines of therapy within seven years of deal closure.

BMS expects to close the transaction by the first half of next year.

Kyowa Kirin to Acquire Orchard Therapeutics

Orchard | October 5, 2023

TOKYO and LONDON and BOSTON, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a Japan-based global specialty pharmaceutical company (J-GSP) creating innovative medical solutions utilizing the latest biotechnology, and Orchard Therapeutics plc (Orchard Therapeutics, Nasdaq: ORTX), a global gene therapy leader, today announced the companies have entered into a definitive agreement under which Kyowa Kirin will acquire Orchard Therapeutics for $16.00 per American Depositary Share (ADS) in cash (approximately $387.4 million, or ¥57.3 billion), under which Orchard shareholders will hold an additional contingent value right (CVR) of $1.00 per ADS. An additional $1.00 CVR will be paid for a total of $17.00 per ADS, or approximately $477.6 million (¥70.7 billion) if the conditions are met.

As Impact of Substance Use Disorders Rise, So Do Innovative Solutions

BioSpace | September 18, 2023

In July, the FDA approved a first-in-human clinical trial of a monoclonal antibody investigated by Cessation Therapeutics that aims to prevent fentanyl overdose. That same month, the regulator greenlighted an over-the-counter nasal spray formulation of naloxone—a staple in reversing opioid overdose since its FDA approval in 1971—from Harm Reduction Therapeutics, a nonprofit biopharma.

Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review

Orchard | September 18, 2023

BOSTON and LONDON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of March 18, 2024.

CymaBay's Seladelpar Achieves High Statistical Significance for the Primary and Key Secondary Endpoints in the Phase 3 RESPONSE Trial in Primary Biliary Cholangitis

CymaBay | September 7, 2023

NEWARK, Calif., Sept. 7, 2023 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced positive topline results from its Phase 3 pivotal RESPONSE study. The study evaluated the safety and efficacy of seladelpar, a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with primary biliary cholangitis (PBC). The registration trial achieved the primary and all key secondary endpoints and supports advancement to regulatory discussions and filing for regulatory approval with the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA).

1st-of-Its-Kind Fentanyl Antibody Treatment Begins Human Trials as Overdose Deaths Rise

ABC7 News | Cessation Therapeutics | August 21, 2023

SAN JOSE, Calif. (KGO) -- A drugmaker funded by a South Bay company is about to begin human testing on a first-of-its-kind fentanyl antibody treatment as fentanyl remains the leading cause of death for people ages 18 to 45 and the cause of 90% of overdose fatalities.

Experts say more options are needed to prevent loss of life."Despite the availability of things like narcan, which is a rescue medication, we continue to see an all-time high of overdoses throughout the country," Cessation Therapeutics CEO Tracy Woody said. "Our big news is we have something that we think will help address this public health crisis."

Born out of San Jose-based investment firm Altamont Pharmaceutical Holdings, Cessation Therapeutics has developed a new monoclonal antibody therapy.

IO Biotech, Inc. Announces $75 Million Private Placement Financing

IO Biotech | August 7, 2023

NEW YORK, Aug. 07, 2023 (GLOBE NEWSWIRE) -- IO Biotech, Inc. (Nasdaq: IOBT), a clinical biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® technology platform, today announced that it has entered into a definitive securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $75 million, before deducting offering expenses. The private placement includes participation from new and existing investors, including Lundbeckfonden BioCapital; Kurma Growth Opportunities Fund; Vivo Capital; Armistice Capital; Marshall Wace; Samsara BioCapital; Novo Holdings; Stonepine Capital Management; PFM Health Sciences, LP; HBM Healthcare Investments (Cayman) Limited; Pivotal Life Sciences; Sunstone Life Science Ventures; Logos Capital; Altamont Pharmaceutical Holdings, LLC; and The Red Hook Fund LP; among others. Members of the company’s management team also participated in this transaction.

Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy

Astellas | August 5, 2023

TOKYO, August 5, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the U.S. Food and Drug Administration (FDA) approved IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. IZERVAY, a new complement C5 inhibitor, is the only approved GA treatment with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.

Amygdala Neurosciences Awarded $2.0 million NIH Grant to Conduct IND Enabling Studies

Amygdala | August 1, 2023

SAN FRANCISCO, Aug. 1, 2023/PRNewswire/ -- Amygdala Neurosciences (a private company) has been awarded a $2.0 million NIH grant to support the project titled "Investigational New Drug (IND)-enabling and Early-Stage Development of Selective, Reversible, Orally Bioavailable ALDH2 inhibitor ANS-00858 to Treat Alcohol Use Disorder." This award is made from the National Institute on Alcohol Abuse and Alcoholism (NIAAA, an Institute of the National Institutes of Health (NIH)).

Cessation Therapeutics Announces Food and Drug Administration Authorization for First-in-Human Clinical Trial of Antibody for Prevention of Fentanyl Overdose

Cessation | July 27, 2023

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Cessation Therapeutics, Inc., (“Cessation”) a clinical-stage biotechnology company advancing biologics that target substances of abuse, announced today that the U.S. Food and Drug Administration (FDA) has authorized the company to initiate a clinical trial in the U.S. for CSX-1004, a monoclonal antibody designed specifically to prevent fentanyl overdose.

The clearance follows the FDA’s review and approval of Cessation’s Investigational New Drug (IND) application and serves as a launching point for Cessation’s first-in-human clinical trials. Cessation’s IND summarized years of the company’s nonclinical safety and manufacturing data and included a detailed description of the planned clinical study in humans.

Iovance Biotherapeutics Announces U.S. Food and Drug Administration Acceptance of the Biologics License Application of Lifileucel for the Treatment of Advanced Melanoma

Iovance | May 26, 2023

SAN CARLOS, Calif., May 26, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for lifileucel for patients with advanced melanoma. The FDA granted lifileucel Priority Review and assigned November 25, 2023 as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA). The FDA is not currently planning to hold an advisory committee meeting to discuss this application and, after a preliminary review, has not at this time identified any potential review issues.

Amgen and TScan Therapeutics Announce Collaboration to Identify Novel Targets in Crohn’s Disease

Amgen and TScan | May 9, 2023

THOUSAND OAKS, Calif. and WALTHAM, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Amgen (NASDAQ:AMGN) and TScan Therapeutics, Inc. (NASDAQ:TCRX), today announced a multi-year collaboration that will use TScan’s proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn’s disease. Under the terms of the agreement, TScan will receive a $30 million upfront payment and is eligible to earn over $500 million in success-based preclinical, clinical, regulatory and commercial milestones as well as tiered single-digit royalty payments.

Astellas Enters Into Definitive Agreement to Acquire Iveric Bio

Iveric Bio | April 30, 2023

KYO & PARSIPPANY, N.J.--(BUSINESS WIRE)--Apr. 30, 2023-- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and IVERIC Bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, “Iveric Bio”) today announced that on April 29, 2023 (Japan time), the Companies have entered into a definitive agreement under which Astellas through Berry Merger Sub, Inc., a wholly-owned subsidiary of Astellas US Holding, Inc., has agreed to acquire 100% of the outstanding shares of Iveric Bio for US$40.00 per share in cash for a total equity value of approximately US$5.9 billion (the “Acquisition”). In the Acquisition, Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas. The total equity value of Iveric Bio in the Acquisition assumes that there are approximately 148.2 million outstanding shares of Iveric Bio common stock on a fully diluted basis. The purchase price represents a premium of 64% to Iveric Bio’s unaffected closing share price of US$24.33 on March 31, 2023, and a premium of 75% to Iveric Bio’s 30 trading day volume weighted average price as of March 31, 2023. The Boards of Directors of both companies have unanimously approved the transaction.

GSK and SCYNEXIS Announce an Exclusive Agreement to Commercialise and Further Develop Brexafemme (ibrexafungerp), a Novel, First-in-Class Medicine to Treat Fungal Infection

Scynexis | March 30, 2023

LONDON and JERSEY CITY, N.J., March 30, 2023 (GLOBE NEWSWIRE) -- GSK plc (LSE/NYSE: GSK) and SCYNEXIS, Inc. (NASDAQ: SCYX), today announced they have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a US FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC). This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.

Under the terms of the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totalling $503 million.

GSK will pay up to $245.5 million if specific development, regulatory, and commercial milestones associated with the IC indication are successfully completed. A further $15 million milestone will be paid upon successful US FDA approval of an additional indication.

Sanofi to Acquire Provention Bio, Adding to Portfolio TZIELD, the First Disease-Modifying Treatment for the Delay of Stage 3 Type 1 Diabetes (T1D)

Provention Bio | March 13, 2023

Paris and Red Bank, N.J. March 13, 2023 Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for $25.00 per share in cash, representing an equity value of approximately $2.9 billion.

Adaptimmune and TCR² Therapeutics Announce Strategic Combination to Create a Preeminent Cell Therapy Company for Solid Tumors

TCR² | March 6, 2023

PHILADELPHIA and OXFORD, U.K. and CAMBRIDGE, Mass., March 06, 2023 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq: ADAP) and TCR² Therapeutics Inc. (Nasdaq: TCRR), today announced entry into a definitive agreement under which Adaptimmune will combine with TCR² in an all-stock transaction to create a preeminent cell therapy company focused on treating solid tumors. The combination provides extensive benefits for clinical development and product delivery supported by complementary technology platforms. As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into 2026.

The lead clinical franchises for the combined company utilize engineered T-cell therapies targeting MAGE-A4 and mesothelin. These targets are expressed on a broad range of solid tumors and are supported by compelling early- and late-stage clinical data. The combined company also has a preclinical pipeline of additional target opportunities with development initially focused on PRAME and CD70.

Cessation Therapeutics’ Anti-Fentanyl Monoclonal Antibody Treatment Shows Promise in Protecting Against Fentanyl-Induced Overdose

pre-IPO Pharma | February 28, 2023

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Cessation Therapeutics (“Cessation”), an early-stage biotechnology company focused on the development of novel immunobiologics for preventing and treating fentanyl overdose, today announced a new study demonstrating that its pioneering anti-fentanyl monoclonal antibody treatment, CSX-1004, may provide robust and durable protection from life-threatening respiratory depression caused by high doses of fentanyl.

The findings come from the company’s ongoing series of proof-of-concept studies in non-human primates. Funded in part by a grant (U01DA051071) from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) through the Helping to End Addiction Long-term Initiative (NIH HEAL Initiative), the studies are designed to assess the antibody’s ability to block the respiratory depressant effect of fentanyl, the attribute of the drug that is ultimately the cause of death in an overdose scenario.

Iveric Bio Announces FDA Accepts New Drug Application and Grants Priority Review for Avacincaptad Pegol for the Treatment of Geographic Atrophy

Iveric Bio | February 16, 2023

PARSIPPANY, N.J.--(BUSINESS WIRE)--Feb. 16, 2023-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for avacincaptad pegol (ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of August 19, 2023. The company also announced that, at this time, the FDA has not identified any potential review issues and the FDA is not currently planning to hold an Advisory Committee meeting for ACP.

“The FDA’s acceptance of our NDA and Priority Review for avacincaptad pegol bring us another significant step closer to delivering a much-needed treatment to AMD patients living with GA,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “We look forward to continuing our collaboration with the FDA throughout the review process.”

Galera Therapeutics Announces Pricing of Registered Direct Offering of $30 Million of Common Stock and Warrants

Galera | February 15, 2023

MALVERN, Pa., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has agreed to sell 14,320,000 shares of common stock and warrants to purchase up to 14,320,000 shares of common stock in a registered direct offering at a combined offering price of $2.095 per share and accompanying warrant. The warrants have an exercise price of $1.97 per share of common stock. The gross proceeds of the offering are expected to be approximately $30 million, before placement agent fees and offering expenses. All shares of common stock and warrants to purchase common stock to be sold in the offering will be sold by Galera. The warrants will be exercisable immediately following their issuance and will expire five years from the date of issuance. The offering is expected to close on or about February 17, 2023, subject to customary closing conditions.

Galera Announces FDA Acceptance and Priority Review of Avasopasem NDA for Radiotherapy-Induced Severe Oral Mucositis

Galera | February 15, 2023

MALVERN, Pa., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review to the New Drug Application (NDA) for avasopasem manganese for radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. There are currently no FDA-approved drugs to reduce SOM for these patients. With the 6-month priority review designation, the Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for this NDA is August 9, 2023. The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application.

The FDA previously granted Breakthrough Therapy and Fast Track designations to avasopasem for the reduction of SOM induced by RT.

Pliant Therapeutics Announces Closing of Upsized Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

Pliant | January 27, 2023

SOUTH SAN FRANCISCO, Calif., Jan. 27, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced the closing of its previously announced upsized underwritten public offering of 9,583,334 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,250,000 additional shares, at a price to the public of $30.00 per share. The aggregate gross proceeds from the offering were approximately $287.5 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Pliant. All shares of common stock were offered by Pliant.

Pliant Therapeutics Announces Positive Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast 320 mg was Well Tolerated and Achieved Statistically Significant FVC Increase in Patients with Idiopathic Pulmonary Fibrosis

Pliant | January 22, 2023

SOUTH SAN FRANCISCO, Calif., Jan. 22, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced 12-week interim data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile. The trial’s exploratory efficacy endpoints assessed changes in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging and biomarkers. Bexotegrast at 320 mg demonstrated a statistically significant mean increase in FVC from baseline at all timepoints, surpassing all lower dose cohorts, and showed a strong treatment effect on FVC percent predicted (FVCpp), QLF and profibrotic biomarkers versus placebo at 12 weeks.

FDA Grants Appeal for Ardelyx's XPHOZAH® (tenapanor)

Ardelyx | December 29, 2022

WALTHAM, Mass., Dec. 29, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH.

Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis

Galera | December 12, 2022

MALVERN, Pa., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. SOM is characterized by the inability to eat solid food or drink liquids and may require the surgical placement of feeding tubes to maintain nutrition and hydration. There are currently no FDA-approved drugs to reduce SOM for these patients.

Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

Ardelyx | November 16, 2022

WALTHAM, Mass., Nov. 16, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced the vote of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The CRDAC voted nine to four that the benefits of treatment with XPHOZAH outweigh its risks for the control of serum phosphorus in adults with CKD on dialysis when administered as a monotherapy and voted ten to two, with one abstention, that the benefits of treatment with XPHOZAH in combination with phosphate binder treatment outweigh its risks.

Iveric Bio Announces Positive Topline Data from Zimura® GATHER2 Phase 3 Clinical Trial in Geographic Atrophy

Iveric | September 6, 2022

PARSIPPANY, N.J.--(BUSINESS WIRE)--Sep. 6, 2022-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced positive topline results from GATHER2, the Company’s second Phase 3 clinical trial of Zimura® (avacincaptad pegol), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA). GATHER2 met its prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months with statistical significance and a favorable safety profile.

Amgen to Acquire ChemoCentryx for $4 Billion in Cash

ChemoCentryx | August 4, 2022

THOUSAND OAKS, Calif. and SAN CARLOS, Calif., Aug. 4, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and ChemoCentryx, Inc., (NASDAQ: CCXI), a biopharmaceutical company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, today announced that the companies have entered into a definitive agreement under which Amgen will acquire ChemoCentryx for $52 per share in cash, representing an enterprise value of approximately $3.7 billion.

Pliant Therapeutics Announces Closing of Upsized Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

Pliant | July 15, 2022

SOUTH SAN FRANCISCO, Calif., July 15, 2022 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced the closing of its previously announced upsized underwritten public offering of 12,432,432 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,621,621 additional shares, at a price to the public of $18.50 per share. The aggregate gross proceeds from the offering were approximately $230.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Pliant. All shares of common stock were offered by Pliant.

Pliant Therapeutics Announces Positive Safety and Efficacy Data from Phase 2a INTEGRIS-IPF Clinical Trial of PLN-74809 in Patients with Idiopathic Pulmonary Fibrosis

Pliant | July 10, 2022

SOUTH SAN FRANCISCO, Calif., July 10, 2022 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), today announced positive data from INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF). The trial met its primary and secondary endpoints demonstrating that PLN-74809 was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile. The trial’s exploratory efficacy endpoints assessing changes in forced vital capacity (FVC) and Quantitative Lung Fibrosis (QLF) imaging, demonstrated a dose-dependent treatment effect on FVC and QLF versus placebo over 12 weeks in PLN-74809 treated patients.

Xeris Biopharma Announces U.S. FDA Approval of Recorlev® (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome

Xeris | December 30, 2021

CHICAGO--(BUSINESS WIRE)--Dec. 30, 2021-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced the U.S. Food and Drug Administration (FDA) approval of Recorlev® (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Krystal Biotech Announces Positive Topline Results from GEM-3 Pivotal Trial of VYJUVEK™ in Patients with Dystrophic Epidermolysis Bullosa

Krystal Biotech | November 29, 2021

PITTSBURGH, Nov. 29, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced positive topline results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as VYJUVEKTM, for the treatment of dystrophic Epidermolysis Bullosa (dystrophic EB).

The primary endpoint of the trial evaluated complete wound healing of topical VYJUVEKTM compared to placebo at six-month timepoints and met statistical significance. VYJUVEKTM is the first non-invasive, topical and redosable gene therapy in development, and the only genetically corrective approach to treat dystrophic EB that has successfully completed a double blinded Phase 3 trial.

ChemoCentryx Announces FDA Approval of TAVNEOS™ (avacopan) in ANCA-Associated Vasculitis

ChemoCentryx | October 8, 2021

SAN CARLOS, Calif., Oct. 08, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. Food and Drug Administration (FDA) has approved TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is often fatal if not treated.

AbbVie and REGENXBIO Announce Eye Care Collaboration

REGENXBIO | September 13, 2021

NORTH CHICAGO, Ill. and ROCKVILLE, Md., Sept. 13, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery.

Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO shall participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan.

Under the terms of the agreement, AbbVie will pay REGENXBIO a $370 million upfront payment with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones. REGENXBIO and AbbVie will share equally in profits from net sales of RGX-314 in the U.S. AbbVie will pay REGENXBIO tiered royalties on net sales of RGX-314 outside the U.S. In addition, REGENXBIO will lead the manufacturing of RGX-314 for clinical development and U.S. commercial supply, and AbbVie will lead manufacturing of RGX-314 for commercial supply outside the U.S.

Sanofi to Acquire Kadmon to Further Strengthen Growth of Transplant Business

Kadmon | September 7, 2021

ARIS, FRANCE and NEW YORK, NY / ACCESSWIRE / September 8, 2021 / Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc. (NASDAQ:KDMN) a biopharmaceutical company that discovers, develops, and markets transformative therapies for disease areas of significant unmet medical needs. The acquisition supports Sanofi's strategy to continue to grow its General Medicines core assets and will immediately add Rezurock™ (belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). The Sanofi and Kadmon Boards of Directors unanimously approved the transaction.

Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (SNDA) Of Gvoke® Kit for the Treatment of Severe Hypoglycemia

Xeris | August 23, 2021

CHICAGO--(BUSINESS WIRE)--Aug. 23, 2021-- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Gvoke Kit will be available as a 1 mg/0.2 mL single dose vial and syringe kit. Gvoke Kit contains one (1) single-dose sterile syringe with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution. With this FDA approval, Xeris will begin manufacturing scale up immediately, and therefore anticipates Gvoke Kit availability early in the first quarter of 2022.

Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of KORSUVA™ (difelikefalin) injection for the treatment of moderate-to-severe pruritus in hemodialysis patients

Cara | August 23, 2021

STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis . KORSUVA™ injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system. The KORSUVA™ injection new drug application (NDA) received Priority Review by the FDA, which is granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

Dialectic Therapeutics Receives $14.4 Million Texas Company Product Development Research Award from the Cancer Prevention & Research Institute of Texas

Dialectic | August 20, 2021

DALLAS, Aug. 20, 2021 /PRNewswire/ -- Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced it has received a $14.4 million Texas Company (TXCO) Product Development Research Award from the Cancer Prevention & Research Institute of Texas (CPRIT). Dialectic will use the funding from this grant award to further advance the clinical development of its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology platform.

Angion Reports Positive Results From Phase 1 Healthy Volunteer Study for ANG-3070 and FDA Authoizatiioon to Initiate Phase 2 Trial in 2021

Angion | August 3, 2021

UNIONDALE, N.Y., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp (NASDAQ:ANGN), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today announced positive results from its Phase 1 study in healthy volunteers for ANG-3070, a novel oral tyrosine kinase receptor inhibitor (TKI) being developed for the treatment of fibrotic diseases. Angion also announced the FDA’s acceptance of an IND application supporting the initiation of a Phase 2 trial in patients with primary proteinuric kidney diseases in 2021. Additionally, the Company announced it will host a Virtual Fibrosis R&D Day on September 20, 2021.

SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections

Scynexis | June 2, 2021

JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. SCYNEXIS has partnered with Amplity Health, a leading global contract commercialization organization, to support U.S. commercialization of BREXAFEMME, with commercial launch scheduled in the second half of this year.

Marker Therapeutics, Inc. Announces Closing of Public Offering of Common Stock

Marker | March 16, 2021

Houston, TX – March 16, 2021 – Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced the closing of an underwritten public offering of 32,282,857 shares of its common stock at a public offering price of $1.75 per share. The gross proceeds to Marker from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $56.5 million.

Angion Biomedica Corp. Announces Pricing of Initial Public Offering of Common Stock and Concurrent Private Placement

Angion | February 5, 2021

UNIONDALE, N.Y., Feb. 05, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (Angion) (NASDAQ:ANGN), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today announced the pricing of its initial public offering on February 4, 2021 of 5,000,000 shares of common stock at a public offering price of $16.00 per share, for gross proceeds of $80,000,000 million, before deducting the underwriting discounts and commissions and offering expenses. All of the shares of common stock are being offered by Angion. Angion has also granted the underwriters a 30-day option to purchase from Angion up to an additional 750,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Angion’s common stock has been approved for listing on The Nasdaq Global Select Market and is expected to begin trading under the ticker symbol “ANGN” on February 5, 2021. The offering is expected to close on February 9, 2021, subject to satisfaction of customary closing conditions.

Vifor Pharma and Angion Sign License Agreement for ANG-3777 in Nephrology Indications

Angion | November 9, 2020

Vifor Pharma and Angion Biomedica Corp. (Angion) today announced the signing of a licensing agreement for the commercialization of ANG-3777, currently being developed for treatment of delayed graft function (DGF) and cardiac surgery-associated acute kidney injury (CSA-AKI). ANG 3777 was engineered to mimic the biological activity of HGF, activating critical pathways in the body’s natural organ repair process following an acute organ injury.

Cessation Therapeutics, LLC Secures $7.1M from NIH to Develop a Fentanyl Overdose Treatment

Cessation | September 30, 2020

Cessation Therapeutics has secured a $7.1M grant (U01DA051071) to develop a monoclonal antibody to treat fentanyl overdose from the National Institutes of Health (NIH) as part of the Helping to End Addiction Long-term ^SM Initiative, or NIH HEAL Initiative ^SM. This award, funded by the National Institute on Drug Abuse (NIDA), part of NIH, will support late-stage preclinical development of the monoclonal antibody through chemistry, manufacturing and controls as well as final toxicology for filing an investigational new drug (IND) application in 2021.

Intra-Cellular Therapies Announces Positive Topline Results from Study 402 Evaluating Lumateperone as Adjunctive Therapy in Patients with Bipolar Depression

Intra-Cellular | September 9, 2020

NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. In Study 402, once daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206; effect size = 0.27). Lumateperone 42 mg also met the key secondary endpoint, the CGI-BP-S Depression Score (p=0.0082; effect size = 0.31).

Pliant Therapeutics Announces Pricing of Initial Public Offering

Plaint | June 2, 2020

SOUTH SAN FRANCISCO, Calif., June 2, 2020 /PRNewswire/ -- Pliant Therapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced the pricing of its initial public offering of 9,000,000 shares of its common stock at a public offering price of $16.00 per share. All of the shares of common stock are being offered by Pliant. In addition, Pliant has granted the underwriters a 30-day option to purchase up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market on June 3, 2020 under the ticker symbol "PLRX." The gross proceeds to Pliant from the initial public offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $144.0 million. The initial public offering is expected to close on June 5, 2020, subject to satisfaction of customary closing conditions.

Citigroup, Cowen and Piper Sandler are acting as joint book-running managers for the initial public offering. Needham & Company is acting as lead manager.

Evofem Announces Pricing of Approximately $100 Million Public Offering of Common Stock

Evofem | June 2, 2020

SAN DIEGO, June 2, 2020 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, today announced the pricing of an underwritten public offering of 28,500,000 shares of its common stock at a price to the public of $3.50 per share. The gross proceeds from the offering to Evofem, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $100 million. The offering is expected to close on or about June 5, 2020, subject to satisfaction of customary closing conditions. In addition, Evofem has granted the underwriters a 30-day option to purchase up to an additional 4,275,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock in the offering are to be sold by Evofem.

Morgan Stanley and Piper Sandler are acting as joint book-running managers, Oppenheimer & Co. Inc. is acting as lead manager and H.C. Wainwright & Co. is acting as lead co-manager for the offering.

U.S. FDA Approves Evofem Biosciences' Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy

Evofem | May 22, 2020

SAN DIEGO, May 22, 2020 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm."There have been a limited number of advances in birth control over the last two decades; Phexxi represents an important step forward in women's health," said Michael A. Thomas, M.D., Chair of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine. "Many of my patients have cycled through numerous contraceptive options and still have not found the right fit for their sexual and reproductive needs. Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy. I look forward to offering this new on-demand option to my patients."

Kadmon Announces Positive Topline Results of Pivotal Trial of Belumosudil (KD025) in Chronic Graft-Versus-Host Disease

Kadmon | May 21, 2020

NEW YORK, NY / ACCESSWIRE / May 21, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced positive topline results from the primary analysis of ROCKstar (KD025-213), the pivotal trial evaluating belumosudil (KD025) in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy.Belumosudil (KD025) achieved clinically meaningful and statistically significant Overall Response Rates (ORRs) of 73% with 200 mg once daily (QD) (95% Confidence Interval (CI): 60%, 83%; p<0.0001) and 74% with 200 mg twice daily (BID) (95% CI: 62%, 84%; p<0.0001). Responses were achieved across key patient subgroups and complete responses were observed in all organ systems.The study had previously met the primary endpoint of Overall Response Rate (ORR) at the interim analysis, which was conducted as scheduled as two months after completion of enrollment and was previously reported. Today's results from the primary analysis, which was conducted six months after completion of enrollment, show even greater efficacy of belumosudil (KD025) in cGVHD patients.

FDA Grants Full Approval of Deciphera Pharmaceuticals’ QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor

Deciphera | May 15, 2020

WALTHAM, Mass.--(BUSINESS WIRE)--May 15, 2020-- Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the U.S. Food and Drug Administration (FDA) has approved QINLOCK™ (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for QINLOCK and reviewed the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) pilot program. The QINLOCK NDA is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities. QINLOCK targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.

"Today’s approval of QINLOCK establishes a new standard of care for patients who have received three prior therapies,” said Margaret von Mehren, MD, Chief of Sarcoma Oncology and Associate Director for Clinical Research, Fox Chase Cancer Center, Philadelphia, Pennsylvania. “GIST is a complex disease and the majority of patients who initially respond to traditional tyrosine kinase inhibitors eventually develop tumor progression due to secondary mutations. In the INVICTUS study, QINLOCK has demonstrated compelling clinical benefit in progression-free and overall survival. QINLOCK is well tolerated and is a crucial new therapy for these patients with a high unmet need.”

Delcath Systems Announces Pricing of $22 Million Public Offering and Uplisting to the Nasdaq Capital Market

Delcath | May 01, 2020

NEW YORK, May 01, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB:DCTH NASDAQ:DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, today announced the pricing of a $22 million underwritten public offering of 2.2 million shares of common stock (or common stock equivalents) and Series F warrants to purchase up to 2.2 million shares of common stock. Each share of common stock (or common stock equivalent) is being sold with one Series F warrant to purchase one share of common stock at a combined public offering price of $10.00 per share and related Series F warrant. The Series F warrants will be immediately exercisable at a price of $10.00 per share and will expire on the fifth anniversary of their issuance date. The offering is expected to close on May 5, 2020, subject to the satisfaction of customary closing conditions.

Delcath also announced that, in connection with the offering, its common stock has been approved for listing on the Nasdaq Capital Market and will begin trading on the Nasdaq Capital Market under the symbol “DCTH” on May 1, 2020.

9 Meters Biopharma, a Rare, Orphan and Unmet Needs GI-Focused Company, is Created with the Transformative Merger Between Innovate Biopharmaceuticals and RDD Pharma

9 Meters | April 30, 2020

RALEIGH, NC / ACCESSWIRE / April 30, 2020 / Innovate Biopharmaceuticals, Inc. (Nasdaq:INNT), today announced the completion of its previously announced merger with privately-held RDD Pharma, Ltd. Following the completion of the merger, Innovate is changing its name to 9 Meters Biopharma, Inc. ("9 Meters" or the "Company") and will continue trading on NASDAQ with the ticker symbol NMTR, effective May 4, 2020.

In addition, the Company announced the signing of approximately $22 million in new financing, led by Orbimed Advisors, LLC, and the signing of the previously announced merger with Naia Rare Diseases, a company developing a proprietary long acting GLP-1 for the treatment of Short Bowel Syndrome. In the financing the Company will issue units consisting of preferred stock and warrants, at a price of $0.5894 per unit, on an as converted to common stock basis. The combined Company will be focused on developing urgently needed treatments for patients with rare, orphan diseases and unmet needs in GI. The combined Company will have two late-stage lead assets funded to their next key inflection points, which include the initiation of a Phase 2 trial in short bowel syndrome in 2H 2020 with top-line results expected in 2021, and the receipt of top-line results for an ongoing Phase 3 trial in celiac disease in 2021.

UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer

UroGen | April 15, 2020

PRINCETON, N.J.--(BUSINESS WIRE)--Apr. 15, 2020-- UroGen Pharma Ltd. (Nasdaq: URGN) today announced the U.S. Food and Drug Administration (FDA) granted expedited approval for Jelmyto™(mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). This landmark approval is based on positive results from the Phase 3 OLYMPUS trial that showed Jelmyto provides an effective, kidney-sparing option for patients with this rare and difficult-to-treat cancer.

Soligenix Announces Positive Top-line Results for its Pivotal Phase 3 FLASH Trial Evaluating SGX301 in Treatment of Cutaneous T-Cell Lymphoma

Soligenix | March 19, 2020

PRINCETON, N.J., March 19, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020.

Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

Puma | February 26, 2020

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens.

“Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “Based on the results of our NALA data, we believe NERLYNX® could be a promising therapeutic opportunity for these patients.”

Kadmon Announces Expanded Results of Interim Analysis of Pivotal Trial of KD025 in cGVHD

Kadmon | February 23, 2020

NEW YORK, NY / ACCESSWIRE / February 23, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced expanded results from the previously reported interim analysis of ROCKstar (KD025-213), its ongoing pivotal trial of KD025 in chronic graft-versus-host disease (cGVHD). The data were presented today in the oral latebreaker session at the 2020 Transplantation & Cellular Therapy (TCT) Meetings.

As announced in November 2019, KD025 met the primary endpoint of Overall Response Rate (ORR) at the study's planned interim analysis, two months after completion of enrollment. KD025 showed statistically significant and clinically meaningful ORRs of 64% with KD025 200 mg once daily (95% Confidence Interval (CI): 51%, 75%; p<0.0001) and 67% with KD025 200 mg twice daily (95% CI: 54%, 78%; p<0.0001). In the expanded KD025-213 dataset presented today, ORRs were consistent with the previously reported interim analysis across key subgroups, including in patients with four or more organs affected by cGVHD (n=69; 64%), patients who had prior treatment with ibrutinib (n=45; 62%) and patients who had prior treatment with ruxolitinib (n=37; 62%). Three patients achieved a Complete Response. Responses were observed in all affected organ systems, including in organs with fibrotic disease. KD025 has been well tolerated: adverse events were consistent overall with those expected to be observed in cGVHD patients receiving corticosteroids, and no apparent increased risk of infection was observed. Additional secondary endpoints, including duration of response, corticosteroid dose reductions, Failure-Free Survival, Overall Survival and Lee Symptom Scale reductions continue to mature and will be available later in 2020.

Xeris Pharmaceuticals Announces Positive Results from the In-Clinic Stage of a Phase 2 Study of its Developmental Ready-To-Use (Rtu) Glucagon in Patients at Risk of Hypoglycemia During and After Aerobic Exercise

Xeris | January 06, 2020

CHICAGO--(BUSINESS WIRE)--Jan. 6, 2020-- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced positive topline results from the in-clinic stage of a Phase 2 study of its developmental ready-to-use (RTU) glucagon for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus (T1D).

Results from the in-clinic stage of the Phase 2 Exercise-Induced Hypoglycemia (EIH) study show that a mini dose of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise. Episodes of hypoglycemia were observed both during and after the prescribed exercise session. Overall, there were more EIH episodes among subjects who received standard of care (placebo plus 50% insulin pump reduction) than subjects who received RTU glucagon plus 50% insulin pump reduction. The use of glucose tablets to treat hypoglycemia during and after exercise was less with RTU glucagon when compared to standard of care. Treatment-emergent adverse events with a mini dose of RTU glucagon were comparable to placebo, including negligible injection site reactions. In this phase of the study, mini doses of RTU glucagon were safe and well tolerated, and no serious adverse events occurred.

FDA Approves Intra-Cellular Therapies’ Novel Antipsychotic, CAPLYTA® (lumateperone) for the Treatment of Schizophrenia in Adults

Intra-Cellular | December 23, 2019

NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. The Company expects to initiate the commercial launch of CAPLYTA in late Q1 2020.

The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score. The most common adverse reactions (≥5% and twice the rate of placebo) for the recommended dose of CAPLYTA vs placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%).

Catalyst Biosciences Announces Global License and Collaboration Agreement to Develop Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration

Catalyst Bio | December 19, 2019

SOUTH SAN FRANCISCO, Calif., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc.(Nasdaq: CBIO), today announced it has entered into a global license and collaboration agreement with Biogen Inc. (Nasdaq: BIIB) for the development and commercialization of pegylated CB 2782 (CB 2782-PEG) for the potential treatment of geographic atrophy (GA) associated dry age-related macular degeneration (dry AMD).

Under the terms of the agreement, Biogen will receive an exclusive worldwide license to develop and commercialize CB 2782-PEG and Catalyst’s other anti-C3 proteases for the potential treatment of dry AMD. Catalyst will perform pre-clinical and manufacturing activities and Biogen will be solely responsible for funding the pre-clinical and manufacturing activities and performing Investigational New Drug (IND)-enabling activities, worldwide clinical development, and commercialization.

Catalyst will receive a $15 million upfront payment and is eligible to receive up to $340 million in clinical, regulatory, and commercial milestone payments plus future tiered royalties based on net sales.

ContraFect Corporation Prices Approximately $10 Million Public Offering of Common Stock

ContraFect | December 17, 2019

YONKERS, N.Y., Dec. 17, 2019 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on discovering and developing direct lytic agents for the treatment of life-threatening infectious diseases, today announced the pricing of its underwritten public offering of 25,650,000 shares of its common stock at a public offering price of $0.39 per share. The gross proceeds from the offering will be approximately $10 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ContraFect. All shares in the offering are to be sold by ContraFect.

ContraFect intends to use the net proceeds of the offering to fund initiation of its Phase 3 DISRUPT trial of exebacase (CF-301) in Staph aureus bacteremia, including right-sided endocarditis, to fund advancement of its portfolio, including IND-enabling activities for an engineered gram-negative lysin directly targeting highly-resistant Pseudomonas aeruginosa, and for working capital and other general corporate purposes.

Scynexis Announces Closing of $35 Million Public Offering of Common Stock and Warrants

Scynexis | December 12, 2019

JERSEY CITY, N.J., Dec. 12, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ : SCYX) today announced the closing of its previously announced underwritten public offering of 38,888,889 shares of common stock and warrants to purchase up to 38,888,889 shares of common stock. Each share of common stock and warrant to purchase one share of common stock were sold at a combined public offering price of $0.90 per share and accompanying warrant. The total gross proceeds to SCYNEXIS from this offering were approximately $35 million, including the exercise of the underwriters' option to purchase additional warrants, before deducting underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any warrants. All of the shares of common stock and warrants were offered by SCYNEXIS.

ContraFect Corporation Prices Approximately $10 Million Public Offering of Common Stock and Concurrent $3 Million Private Placement of Common Stock to Pfizer

ContraFect | December 10, 2019

YONKERS, N.Y., Dec. 10, 2019 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on discovering and developing direct lytic agents for the treatment of life-threatening infectious diseases, today announced the pricing of its underwritten public offering of 37,150,000 shares of its common stock at a public offering price of $0.27 per share. The gross proceeds from the public offering will be approximately $10 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ContraFect. In addition, ContraFect also announced that Pfizer Inc. has agreed to purchase 11,111,111 shares of ContraFect’s common stock pursuant to a stock purchase agreement with ContraFect at the price per share in the public offering, in a separate private placement transaction that is expected to close concurrently with the public offering. The gross proceeds from the private placement will be $3 million. All shares in the public offering and private placement are to be sold by ContraFect.

ContraFect intends to use the net proceeds of the public offering and private placement to fund initiation of its Phase 3 DISRUPT trial of exebacase (CF-301) in Staph aureus bacteremia, including right-sided endocarditis, to fund advancement of its portfolio, including IND-enabling activities for an engineered gram-negative lysin directly targeting highly-resistant Pseudomonas aeruginosa, and for working capital and other general corporate purposes.

Ardelyx Announces Positive Topline Results from Pivotal Phase 3 Phreedom Study Evaluating Tenapanor in CKD Patients on Dialysis

Ardelyx | December 03, 2019

FREMONT, Calif., Dec. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. In the study, patients randomized to the tenapanor arm were treated in a 26-week open-label treatment period and were then re-randomized to a 12-week double-blind, placebo-controlled randomized withdrawal period. The PHREEDOM study met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change (-1.4 mg/dL, p<0.0001), as compared to placebo. During the 26-week treatment period, 77% of tenapanor-treated patients in the intent-to-treat population (n=408) had a decrease in serum phosphorus, with a mean reduction from baseline of 2.0 mg/dL. Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis. If approved, tenapanor will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.

"If approved, tenapanor is poised to change the way we manage hyperphosphatemia in patients on dialysis," said Myles Wolf, M.D., MMSc, Charles Johnson, M.D. professor of medicine and chief of Duke Nephrology. "Tenapanor would be a first-in-class therapy that targets the primary pathway of phosphate absorption to significantly lower serum phosphate while requiring patients to take just one small pill twice per day. This would make tenapanor an important innovation and potentially an ideal first-line therapy for patients receiving dialysis for whom new effective treatments are desperately needed."

Evofem Biosciences Reports Positive Top-Line Results from Phase 2b Study of Amphora® for Prevention of Chlamydia and Gonorrhea in Women

Evofem | December 02, 2019

SAN DIEGO, Dec. 2, 2019 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical stage biopharmaceutical company, today announced positive top-line results from AMPREVENCE, a Phase 2b clinical trial evaluating the efficacy and safety of its lead product candidate Amphora® for the prevention of urogenital chlamydia and gonorrhea in women. The study met both its primary and secondary endpoints of reducing the risk of chlamydia and gonorrhea infection, respectively, and demonstrated that Amphora was generally safe and well tolerated.

In this landmark study, the infection rate of chlamydia among women who used Amphora for the four-month study period was 4.9% (n=14/288) compared to 9.8% among those who used placebo for four months (n=28/287) (p=.024), a relative risk reduction of 50% in the primary endpoint.

Among the reported cases of gonorrhea infection, the infection rate was 0.7% in the Amphora arm (n=2/280), compared to 3.2% in the placebo arm (n=9/277) (p=.03), a relative risk reduction of 78% in the secondary endpoint.

ChemoCentryx and VFMCRP Announce Positive Topline Data from Pivotal Phase III ADVOCATE Trial Demonstrating Avacopan’s Superiority Over Standard of Care in ANCA-Associated Vasculitis

ChemoCentryx | November 25, 2019

MOUNTAIN VIEW, Calif. and ST. GALLEN, CH, Nov. 25, 2019 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (NASDAQ: CCXI) and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced positive topline data from the pivotal Phase III ADVOCATE trial of avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).

This global study, in which a total of 331 patients with acute ANCA vasculitis were enrolled, met both of its primary endpoints, disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS. Remission was defined as a BVAS score of zero and being off glucocorticoid treatment for ANCA vasculitis for at least the preceding four weeks. The pre-specified primary endpoints were remission of acute vasculitis activity at week 26 and sustained remission at week 52, where avacopan therapy was at least statistically non-inferior to the currently used glucocorticoid-containing standard of care (glucocorticoid SOC). The two primary endpoints were tested sequentially using a gatekeeping procedure to preserve the Type I error.

Ardelyx and Kyowa Kirin Expand Partnership with Two Additional Agreements

Ardelyx | November 25, 2019

FREMONT, Calif. and TOKYO, Nov. 25, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases and Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), a Japan-based Global Specialty Pharmaceutical Company, today announced the expansion of their partnership with two new agreements.

In the first agreement, the companies have established a two-year research collaboration, whereby Ardelyx will execute a research plan, in which Kyowa Kirin will also join, to advance two of Ardelyx's ongoing research programs focused on the identification and design of compounds to two undisclosed targets. In return, Kyowa Kirin will pay Ardelyx$10 million ($5 million a year for two years) to support the ongoing research. Following the end of the research period, Kyowa Kirin will have the option to license any candidates nominated by the companies for further development and commercialization in certain specified territories, with additional commitments payable to Ardelyx of up to $10.5 million in upfronts and up to $500 million in development and sales milestones. The research collaboration will be governed by a joint research committee. Additional terms were not disclosed.

Under the second agreement, Kyowa Kirin has made a $20 million equity investment in Ardelyx at $6.96 for 2,873,563 shares.

Amygdala Neurosciences Announces $5.6M Financing and Dr. Mack Mitchell's Expanded Role as CMO

Amygdala | November 18, 2019

SAN FRANCISCO, Nov. 18, 2019 /PRNewswire/ -- Amygdala Neurosciences, Inc. (a private company) is developing pharmacotherapies to address the growing unmet need associated with substance use disorder. Development of our lead compound ANS-6637 is supported by the November close of $5.6M financing and with the appointment of Dr. Mack Mitchell, a current member of the Amygdala Board of Directors, to also serve as the Amygdala Chief Medical Officer (CMO).

Dr. Mitchell brings over two decades of leadership in the field of basic and clinical addiction research. His experience includes serving as the Executive Vice President of Health System at the University of Texas Southwestern Medical Center; Chief of Gastroenterology and the Medical Director of Ambulatory Services at Johns Hopkins Bayview Medical Center; the Chairman of Internal Medicine at Carolinas Medical Center; a member of numerous NIH study sections, councils and committees; and a recipient of NIH/NIAAA awards for addiction research.

Pliant Therapeutics Announces Strategic Collaboration to Develop Novel Therapies for NASH and Fibrotic Diseases

Pliant | October 23, 2019

SOUTH SAN FRANCISCO — October 23, 2019 — Pliant Therapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced it has entered into a strategic collaboration and license agreement with Novartis covering the development and commercialization of Pliant’s preclinical product candidate, PLN-1474 and up to three additional integrin targets. PLN-1474 is an internally discovered small molecule selective inhibitor of integrin αVβ1, currently being developed for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis (NASH).

“Our research continues to generate compelling preclinical evidence that supports the advancement of PLN-1474 as a clinical candidate and validates our approach of evaluating αVβ1 integrin inhibition to treat advanced liver fibrosis associated with NASH,” said Bernard Coulie, M.D., Ph.D., president and chief executive officer of Pliant Therapeutics. “Pairing Pliant’s leading integrin biology and drug discovery capabilities with Novartis, a world-leader with one of the broadest pipelines investigating mono and combination therapies for liver diseases including NASH, will support our goal of developing novel therapies for fibrotic diseases and potentially bring meaningful treatment options to patients.”

Ardelyx Receives FDA Approval for IBSRELA® (Tenapanor), an NHE3 Sodium Transport Inhibitor, for the Treatment of Irritable Bowel Syndrome with Constipation

Ardelyx | September 12, 2019

FREMONT, Calif., Sept. 12, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that the U.S. Food and Drug Administrationhas approved IBSRELA® (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients.

"IBSRELA has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States," commented Mike Raab, president and chief executive officer of Ardelyx. "This approval is an extremely important and rewarding milestone for Ardelyx, and represents the culmination of years of dedication to advancing our discoveries and medicines in an effective and rigorous manner. We look forward to establishing a commercial collaboration with a partner that has the capabilities to drive the successful launch and marketing of IBSRELA in this large and underserved IBS-C patient population."

Xeris Pharmaceuticals Receives U.S. FDA Approval for Gvoke™ (Glucagon), The First Ready-To-Use Stable Liquid Glucagon For Severe Hypoglycemia

Xeris | September 10, 2019

CHICAGO--(BUSINESS WIRE)--Sep. 10, 2019-- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced today that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for GVOKE™ (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.

GVOKE is the first glucagon product approved that can be administered via a prefilled syringe (GVOKE PFS) or auto-injector (GVOKE HypoPen™), vastly reducing the steps to prepare and administer glucagon in the event of severe hypoglycemia, or dangerously low blood sugar levels. These innovative formats are designed to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer quickly and simply. GVOKE will be available in two doses: a 0.5 mg/0.1 mL dose for pediatric patients and a 1 mg/0.2 mL dose for adolescent and adult patients. GVOKE is contraindicated in patients with pheochromocytoma, insulinoma, and patients with a known hypersensitivity to glucagon or to any of the excipients in GVOKE.

Ardelyx Announces Positive Results From The Pivotal Phase 3 AMPLIFY Study Tenapanor In Dailysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment

Ardelyx | September 03, 2019

FREMONT, Calif., Sept. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive results from AMPLIFY, a pivotal Phase 3 study of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone. The AMPLIFY study met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant (p=0.0004) reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone. Tenapanor is an investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis.

"I believe tenapanor has the potential to change the landscape of hyperphosphatemia treatment – finally, a novel agent that can lower serum phosphorus alone or in conjunction with binders," said Glenn Chertow, M.D., M.P.H., division chief of nephrology and professor of medicine at Stanford University. "Faced with an extremely high mortality rate of approximately 18% per year in dialysis patients, we are very focused on managing and treating elevated serum phosphorus. Elevated serum phosphorus is associated with mortality, cardiovascular events and bone fracture among patients receiving dialysis, and more than half of patients cannot achieve control of hyperphosphatemia despite taking a fist full of binders three times daily with meals. The AMPLIFY study results provide convincing evidence that controlling hyperphosphatemia will soon be within our reach."

Soligenix Announces Positive Recommendation by Independent Data Monitoring Committee on its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer

Soligenix | August 28, 2019

PRINCETON, N.J., Aug. 28, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today it has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue enrolling into the company's Phase 3 "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC). Following its prospectively defined interim analysis, including unblinded assessment of the study's primary efficacy endpoint, the DMC recommended that approximately 70 additional subjects be randomized into the trial, increasing the study sample size from 190 to 260 evaluable subjects. The DMC's recommendation indicates that a beneficial SGX942 effect has been observed; however, to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint, an increase was required to take into account any potential variability and/or distribution changes observed in the Phase 3 study patient population that may have differed from the initial protocol design assumptions. No safety concerns were reported by the DMC based on the interim analysis. The study remains on target to complete enrollment and provide topline results in the first half of 2020.

Deciphera Pharmaceuticals Announces Positive Top-line Results from INVICTUS Pivotal Phase 3 Clinical Study of Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors

Deciphera | August 13, 2019

WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 13, 2019-- Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced positive top-line data from the INVICTUS pivotal Phase 3 clinical study of ripretinib, a broad-spectrum KIT and PDGFRα inhibitor, in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST).

“There is a dire unmet need for new therapies that can deliver effective disease control for patients with advanced GIST who have failed currently approved treatment options,” said Margaret von Mehren, MD, Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. “These top-line data from a Phase 3, randomized, placebo-controlled study are highly impressive and suggest that ripretinib’s approach of targeting the broad spectrum of KIT and PDGFRα mutations known to drive GIST can significantly improve progression free survival in the most heavily pretreated patients. Particularly notable is the magnitude of benefit observed for overall survival in this study.”

Broadly Neutralizing Antibody Prevents Lethality From Fentanyl Class Of Synthetic Opioids

The Scripps Research Institute | June 24, 2019

LA JOLLA, CA – Synthetic opioids such as fentanyls have become the leading cause of drug-related deaths in recent years—not only due to their extreme potency and addictive properties, which make overdoses more likely, but because current approaches to treating overdoses fall short.

In a breakthrough that appears in Journal of the American Chemical Society, scientists at Scripps Research developed experimental antibodies that block the lethal effects of synthetic opioids, preventing death. In a rodent study, the team found that their so-called “broadly neutralizing antibodies” worked against an array of fentanyls, including a notorious form known as “China White” and the most powerful of all fentanyls, carfentanil.

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As a next step, Janda is looking to translate his lab’s recent discoveries into a human-antibody-based vaccine. Janda’s laboratory will be advancing the research in partnership with Cessation Therapeutics Inc., a San Diego-based biotech company that has licensed the technology.

Pliant Therapeutics Reports Positive Results of Phase1 Clinical Study Support Advancement of PLN-74809 for Idiopathic Pulmonary Fibrosis

Pliant Therapeutics | Apr 9, 2019

SOUTH SAN FRANCISCO, CA — April 9, 2019 — Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today announced the successful completion of its first-in-human clinical study of its lead product candidate, PLN-74809. The small molecule inhibitor of the αVβ6 and αVβ1 integrins was shown to be safe and well tolerated in healthy volunteers, and the results support further development in patients with idiopathic pulmonary fibrosis (IPF), a chronic and progressive fibrotic lung disease with few treatment options.

The randomized, double-blind, placebo-controlled study of PLN-74809 clearly demonstrated the small molecule’s good oral bioavailability in humans and its dose-proportional pharmacokinetics after a single dose and following 14 days of once-daily administration, at doses ranging from 10 to 75 mg. The compound was well-tolerated across all doses in 71 study participants and its long half-life supports once-daily dosing.

Merck to Acquire Immune Design

Merck | Feb 21, 2019

KENILWORTH, N.J. & SEATTLE & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Immune Design (NASDAQ:IMDZ), today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Immune Design for $5.85 per share in cash for an approximate value of $300 million.

“Scientists at Immune Design have established a unique portfolio of approaches to cancer immunization and adjuvant systems designed to enhance the ability of a vaccine to protect against infection, which could meaningfully improve vaccine development," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This acquisition builds upon Merck’s industry-leading programs that harness the power of the immune system to prevent and treat disease.”

Catabasis Pharmaceuticals Announces Pricing Of $20 Million Underwritten Public Offering

Catabasis | Feb 6, 2019

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 6, 2019-- Catabasis Pharmaceuticals, Inc. (“Catabasis,” the “Company,” “we,” “our,” or “us”) (NASDAQ: CATB), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering of an aggregate of 4,000,000 units at a public offering price of $5.00 per unit. Each unit is comprised of one share of common stock and 0.5 of a warrant to purchase one share of common stock for a total of 4,000,000 shares of common stock and warrants to purchase 2,000,000 shares of common stock.

Tetraphase Pharmaceuticals Announces FDA Approval Of XERAVA™ (Eravacycline) For Complicated Intra-Abdominal Infections (CIAI)

Tetraphase | August 27, 2018

Tetraphase Pharmaceuticals, Inc.(NASDAQ: TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of XERAVA™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem.

Soligenix Announces Appointment of Mark Pearson to its Board of Directors

Soligenix | July 24, 2018

Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the appointment of Mark Pearson, Chief Executive Officer (CEO) of Altamont Pharmaceutical Holdings, LLC, to its Board of Directors.

Soligenix, Inc. Prices $8,000,000 Public Offering At The Market

Soligenix | June 28, 2018

Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced the pricing of an underwritten public offering of 7,766,990 shares of its common stock and warrants to purchase 3,106,796 shares of common stock at a combined public offering price of $1.03 per share and warrant. The warrants will have an initial per share exercise price of $2.25, subject to customary adjustment, are exercisable immediately and will expire forty-two (42) months from the date of issuance.

Xeris Pharmaceuticals Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

Xeris | June 26, 2018

Xeris Pharmaceuticals, Inc. (NASDAQ:XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced the closing of the Company’s initial public offering of 6,555,000 shares of common stock at a public offering price of $15.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 855,000 shares of common stock. Aggregate gross proceeds to the Company were approximately $98.3 million, before underwriting discounts and commissions and estimated offering expenses payable by the Company. All of the shares in the offering were sold by Xeris Pharmaceuticals. Xeris Pharmaceuticals’ common stock is listed on The NASDAQ Global Select Market under the ticker symbol “XERS.”

Jefferies, Leerink Partners, RBC Capital Markets and Mizuho Securities acted as joint book running managers for the offering.

Catabasis Pharmaceuticals Announces Closing Of $42M Underwritten Public Offering

Catabasis | Jun 22, 2018

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 22, 2018-- Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of an aggregate of 42,000,000 units. Each unit is comprised of one share of common stock and one common warrant to purchase one share of common stock, at a price of $1.00 per unit. Each common warrant has an exercise price of $1.20 per share and is exercisable immediately. The common warrants will expire five years from the date of issuance. The gross proceeds of the offering are $42 million, prior to deducting the underwriting discount and commissions and other estimated offering expenses.