BioSpace News Archive

Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, confirmed today that it completed an End-of-Phase/Pre-Phase 3 meeting with FDA on its plans to initiate a Phase 3 registrational clinical trial of soquelitinib (formerly CPI-818), the Company’s ITK inhibitor product candidate, in relapsed peripheral T cell lymphoma (PTCL).

Aziyo Biologics, Inc. announced a change of the Company’s name to Elutia Inc.

Vaxart, Inc. (Nasdaq: VXRT) today announced top-line data from the Phase 2 challenge study of its oral tablet monovalent norovirus vaccine candidate (NCT05212168).

Align Technology, Inc., a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, introduced the Invisalign® Palatal Expander System,* a modern and innovative direct 3D printed device based on a proprietary and patented technology.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for calcium gluconate in sodium chloride injection, 1000 mg/50 mL and 2000 mg/100 mL.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that Company management will participate in the Morgan Stanley 21st Annual Global Healthcare Conference and Cantor Fitzgerald Global Healthcare Conference 2023.

Olema Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for women’s cancers, announced that the Company will present at the following upcoming investor conferences in September.

Aditxt, Inc. announced that it has closed its previously announced private placement for the purchase and sale of an aggregate of 1,000,000 shares of common stock at a purchase price of $10.00 per share and accompanying warrant, priced at-the-market under Nasdaq rules.

Cardio Diagnostics Holdings, Inc, a pioneer of artificial intelligence-driven precision cardiovascular medicine tests, announced its AI-driven Epi+Gen CHD and PrecisionCHD tests will be leveraged in a research study led by Dr. Vishal Gupta, a cardiologist and the head of the Heart Attack Prevention Clinic at Ascension Borgess.

HighLife SAS announced the introduction of a new valve size in its clinical trials, the Large Annulus Valve, designed for patients with larger anatomies.