Optimism for the potential of a bifunctional fusion protein complex in development at HCW Biologics Inc. for the potential treatment of pancreatic cancer jolted company shares (NASDAQ:HCWB) skyward to $4.73 on Oct. 28, up 62%, though still far short of the company's $8 per share summer market debut. The company, founded and led by former Altor Bioscience Corp. CEO Hing Wong, gained FDA clearance to start a first-in-human phase Ib trial of the candidate, HCW-9218.
A phase III trial of Rafael Pharmaceuticals Inc.’s devimistat in pancreatic cancer has failed, sending shares in its publicly listed holding company through the floor. Shares in Rafael Holdings (NYSE:RFL) closed Oct. 28 down 73% to $8.09, for a loss of $22.08 after an independent data monitoring committee also recommended a separate phase III trial of devimistat in acute myeloid leukemia should be stopped due to lack of efficacy.
To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.
Shares of Angion Biomedica Corp. tumbled more than 50% Oct. 27 on disappointing top-line data from its phase III study testing ANG-3777’s ability to improve organ function in patients receiving deceased donor kidney transplants. The company’s management, however, remained cautiously optimistic that the safety results and signals of biological activity could bode well for an exploratory phase II study testing the drug in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass, which is expected to read out later this quarter.
What Cortexyme Inc.’s chief operating officer Christopher Lowe called “a giant step forward” in Alzheimer’s disease (AD) research with atuzaginstat (COR-388) was viewed differently by Wall Street, which walloped shares (NASDAQ:CRTX) by 76%, or $44.17, causing the stock to close at $13.51.
LONDON – A U.K. study following up 32.5 million people for 28 days after their first dose of a COVID-19 vaccine has shown an increased risk of hemorrhagic stroke after receiving the Pfizer Inc./Biontech SE product, and confirmed case reports of an increased risk of developing Guillain-Barré syndrome after the Astrazeneca plc vaccine.
Interim data from a phase II/III study of Moderna Inc.’s COVID-19 vaccine show a robust antibody response in children ages 6 through 11, stronger than the one the company found in adolescents. Two 50-mcg doses given 28 days apart also produced a favorable safety profile that nearly mirrored that of adolescents and adults.
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