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. Read More
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. Read More
Secarna Pharmaceuticals GmbH & Co. KG and Denali Therapeutics Inc. have expanded a central nervous system research partnership as the gene silencing field heats up. Read More
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition. Read More
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. Read More
Targeting the thousands of rare inherited diseases that have no treatments in the U.S., a newly launched public-private group plans to pursue efforts to optimize and streamline the gene therapy development process. Read More
As part of its ongoing research into drug advertising, the FDA’s Office of Prescription Drug Promotion (OPDP) is proposing a study to understand how “targeted mechanism of action” (MoA) claims influence patients and health care providers when they’re used in drug ads and other promotional materials. Read More
Antengene Corp. Ltd. has formed a partnership with Legochem Biosciences Inc. to jointly develop new antibody-drug conjugates (ADCs) primarily for cancer. The partners will integrate antibodies from Antengene with Legochem’s ADC technology. Read More
New hires and promotions in the biopharma industry, including: Cytovation, Elevar, Exo, Eyegate, Genep, Harpoon, HCW, Nervgen, Noxxon, Onchilles, Travecta. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Alkermes, Aptevo, Canbridge, Esocap, Gilead, Humanigen, Krystal, Merck, Revive, Seres, SQZ, Ultimovacs, Vaxart. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angel, Atamyo, Axcella, Biovie, Corvus, Emmaus, Geron, Mereo, Moderna, Nova Mentis, Precigen, Seagen. Read More
