Cogent Biosciences Inc. is now lining up two NDA submission for its tyrosine kinase inhibitor bezuclastinib. Phase III results from its Peak study of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant gastrointestinal stromal tumors (GIST) showed median progression-free survival of 16.5 months compared to 9.2 months for sunitinib as a monotherapy. Cogent intends to submit an NDA for bezuclastinib in the first half of 2026 to treat GIST. It also intends to file an NDA this year based on positive phase II study data of bezuclastinib produced in July for treating non-advanced systemic mastocytosis. The company’s stock (NASDAQ:COGT) surged 142% at midday to $35.91 a share.

Lyell scoops up phase I colorectal asset for $40M up front, shares

Lyell Immunopharma Inc. is buying global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer, from Innovative Cellular Therapeutics Inc. (ICT) for an up-front payment of $40 million and 1.9 million shares of Lyell common stock. ICT, of Rockville, Md., is also eligible for eventual royalties, along with additional cash consideration that consists of a potential $30 million if a clinical milestone is met, up to $115 million in payments if late-stage regulatory goals are reached, and as much as $675 million if sales bars are hit. The drug at the center of the deal has yielded encouraging data in phase I experiments. Shares of South San Francisco-based Lyell (NASDAQ:LYEL) did not react much, trading midday at $17.46, down less than 1%.

Pfizer, Metsera reach $10B merger agreement as Novo bows out

Pfizer Inc. emerged over the weekend as the winner of the bidding war for Metsera Inc., with the two reaching an amended agreement late Nov. 7 that values the obesity drugmaker at about $10 billion, while Novo Nordisk A/S confirmed that it does not intend to increase its offer. As the U.S. FTC granted early clearance for the deal, the companies expect the deal to close shortly after Metsera’s stockholder meeting Nov. 13. The acquisition gives Pfizer potential entry into the multibillion-dollar obesity space, bringing aboard GLP-1 receptor agonist MET-097i and amylin analogue MET-233i, along with two additional oral GLP-1s and preclinical-stage nutrient-stimulated hormone therapeutics.

FDA to ease warning on HRTs to boost women’s health

The U.S. FDA is turning the clock back more than 20 years in an effort to advance women’s health by narrowing the boxed warning on hormone replacement therapies (HRT) for menopause. The agency announced today that it’s working with companies to update their HRT labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia. However, systemic stand-alone estrogen products will still retain a boxed warning for endometrial cancer. The broad warning was added in the early 2000s following the release in 2003 of a Women’s Health Initiative study that found a statistically nonsignificant increase in the risk of breast cancer diagnosis. “Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” FDA Commissioner Marty Makary said. He attributed that to a paternalistic medical profession that too often dismisses women’s health issues.

Lilly moves deeper into RNAi with $1.2B Sanegene obesity deal

In a deal worth $1.2 billion, Suzhou Sanegene Bio Inc. and Eli Lilly and Co. are partnering up to advance RNAi candidates for metabolic diseases based on Sanegene's tissue selective delivery technology. Under the deal terms, Sanegene will receive an undisclosed up-front payment and equity investment and will be eligible to receive up to $1.2 billion in discovery, development, regulatory, and commercial milestone payments, as well as tiered royalties on sales. Sanegene will be responsible for discovery and identification of the optimized LEAD (ligand and enhancer assisted delivery)-based RNAi molecule for each program, while Lilly will be responsible for the subsequent IND-enabling studies, clinical development and commercialization.

Microglia acting like T cells mitigate Alzheimer’s progression

In Alzheimer’s disease, microglia act as a double-edged sword. They can either protect the brain or worsen the damage, depending on their activation state. Inflammatory activation harms healthy neurons. However, a study reveals that a special type of microglia expressing specific receptors and behaving like T cells may help mitigate this neurodegenerative condition. “We discovered that these molecules, long known to immunologists for their roles in B and T lymphocytes, also regulate microglial activity,” Anne Schaefer, senior author of the study, told BioWorld.

Also in the news

A2, Alebund, Arena, Aulos, Bayer, Bioatla, Biofrontera, Coherus, Eledon, Eli Lilly, Evinova, Ferrer, Fresenius Kabi, Gilead, Harbour, Indapta, Intellia, Johnson & Johnson, Ligand, Nurix, Pelthos, Poltreg, Ratio, Regeneron, Rhythm, Sanofi, Shinobi, Synthekine, Tahoe