Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s plaque staging system have breathed new life into the company’s shares, boosting them by 7% in Nov. 10 trading.
Medical Microinstruments Inc., reported the U.S. FDA approval of an investigational device exemption for a study using its Symani surgical system for treating Alzheimer’s disease, one of its earliest forays into the brain.
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
A primary endpoint failure but with outstanding estimated glomerular filtration rates and impressive safety data in the phase II trial called Bestow are adding up to plans for later-stage work with Eledon Pharmaceuticals Inc.’s tegoprubart (tego) for preventing rejection in de novo kidney transplant.
Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
Eli Lilly and Co.’s amylin receptor agonist, eloralintide, showed impressive weight loss and improved tolerability in phase II results reported at ObesityWeek 2025, setting the stage for a phase III trial to start next month. The once-weekly drug demonstrated superior mean weight reductions from 9.5% to 20.1% vs. only 0.4% for placebo over 48 weeks, with all treatment arms meeting the primary endpoint, mean percent change in body weight from the average baseline of 240.5 lbs. (109.1 kg).
Celltrion Inc. scored a hat-trick of deals to license new antibody candidates, including a $744 million deal with Kaigene Inc. Nov. 3, and a near $500 million deal with Mustbio Co. Ltd. Oct. 31.
RSS
