Kala Pharmaceuticals Announces FDA Acceptance of IND Application for KPI-012 for the Treatment of PCED
-- On-track to initiate Phase 2b trial in 1Q 2023; Topline data expected in 1Q 2024 -- -- Received remaining $25...
COVID-19
SI-BONE, Inc. Announces FDA Clearance for Expanded Rod Compatibility with the iFuse Bedrock Granite® Implant System
New Indications Include Use with a Broad Class of Commercially Available Rods iFuse Bedrock Granite® iFuse Bedrock Granite® SANTA CLARA,...
Acer Therapeutics and Relief Therapeutics Announce U.S. FDA Approval of OLPRUVA™ for Patients with Urea Cycle Disorders
New FDA-approved formulation for patients living with urea cycle disorders $42.5 million of non-dilutive debt funding available to Acer that,...
TRACON Pharmaceuticals Announces up to $30M Non-Recourse Non-Dilutive Financing Related to Arbitration Award Decision Expected in Q1 2023
Initial $3.5M Funding Maintains Cash Runway of Mid-2023SAN DIEGO, Dec. 27, 2022 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (Nasdaq: TCON), a...
Junshi Biosciences and Hikma Sign Exclusive Licensing Agreement for Cancer Treatment Drug Toripalimab for the Middle East and North Africa Region
SHANGHAI, China, Dec. 26, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a...
Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on...
Coherus and Junshi Biosciences Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on...
Outlook Therapeutics® Enters Definitive Agreement for $31.8 Million Unsecured Convertible Promissory Note
ISELIN, N.J., Dec. 23, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a biopharmaceutical company working to...
atai Life Sciences Announces Results from the Kures Therapeutics Phase 1 Trial of KUR-101
- This two-part phase 1 trial in healthy volunteers was designed to assess the safety, pharmacokinetics, and analgesic activity of...
Outlook Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
ISELIN, N.J., Dec. 23, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and...
Nykode Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference
OSLO, Norway, Dec. 23, 2022 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the...
Bavarian Nordic Enters Agreement Valued up to USD 83 Million with the U.S. Department of Defense to Further Advance the Development of Equine Encephalitis Virus Vaccine
Total considerations of up to USD 83 million with the majority secured for Phase 2 development of the multivalent MVA-BN®...
Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), December 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that...
Mersana Therapeutics Announces Research Collaboration and Commercial License Agreement with Merck KGaA, Darmstadt, Germany to Develop Novel Immunosynthen Antibody-Drug Conjugates
Collaboration focuses on discovering novel STING-agonist ADCs for up to two targets leveraging Mersana’s proprietary immunostimulatory platform Mersana to receive...
Update on Proposed Acquisition of Grupo Somar
MIAMI and BARRANQUILLA, Colo., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a...
CENTOGENE Reports Second Quarter and First Half 2022 Financial Results
CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life...
Revive Therapeutics Announces Submission of Type C Meeting Request to FDA for Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19
TORONTO, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a...
Ryvu Therapeutics Announces Closing of Equity Offering with Gross Proceeds Over PLN 250 Million
KRAKOW, Poland, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Ryvu Therapeutics , a clinical-stage drug discovery and development company focusing on novel...
Ceapro Inc. Receives Approval from Health Canada to Commence Phase 1/2a Human Clinical Trial Assessing Avenanthramide Tablets
- Ceapro is pioneering approach with a natural product as a potential anti-inflammatory - Clinical study to be conducted with the...
Y-mAbs Announces Partnership Regarding Early Access Program for DANYELZA (naxitamab-gqgk) in Europe
NEW YORK, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical...