A second win for Cogent pushes the company toward two NDAs
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.

A second win for Cogent pushes the company toward two NDAs
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.
Lyell loves it: ICT phase I mCRC prospect floats license deal
CEO Lynn Seely said Lyell Immunopharma Inc. is going “full steam ahead” with development of rondecabtagene autoleucel (ronde-cel, also known as LYL-314) amid the excitement of the firm’s latest news: the buy of global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer (mCRC), from Innovative Cellular Therapeutics Inc. (ICT) for an up-front payment of $40 million and 1.9 million shares of Lyell common stock.
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 after market close Nov. 7 that values the obesity drugmaker at about $10 billion. The next day, the other contender, Novo Nordisk A/S, confirmed it does not intend to increase its most recent offer.
Today's news in brief
BioWorld briefs for Nov. 11, 2025.
FDA easing warning on HRTs to boost women’s long-term health
The U.S. FDA is turning the clock back more than 20 years to advance women’s health by narrowing the boxed warning on hormone replacement therapies (HRTs) for menopause. The agency announced at a Nov. 10 news conference that it’s working with companies to update their HRT labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia.
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 to advance RNAi candidates for metabolic diseases based on Sanegene's tissue selective delivery technology.
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.

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Bioxcel Therapeutics Inc.’s phase III results in bipolar disorders or schizophrenia could bring Igalmi (BXCL-501) out of the clinic and into patients' homes for easier treatment.

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Analysis and data insight

Positive readouts validate pipelines, fuel drug developer rally
Drug developer stocks strengthened further through September and October, with the BioWorld Drug Developers Index (BDDI) rising from a 7.69% gain at the end of August, to 24.91% through the third quarter and 28.96% at October’s close. The BDDI outperformed both the Nasdaq Biotechnology Index and...
Biopharma financings jump 86% in October, raising $13.2B
Financings
Biopharma financings from January through October 2025 totaled $61.45 billion, roughly in line with the $61.04 billion raised during the same period in 2023 but down sharply from last year’s $93.83 billion.
Big pharma drives surge in biopharma job cuts in 2025
Asia-Pacific
In 2025, the biopharma industry has undergone a wave of workforce reductions that surpasses previous years’ trends. Multiple major pharma companies have announced sizeable job cuts, driven by a convergence of shifting regulatory terrain, vaccine slowdowns and cost-structure rationalization.
Incyte aboard, SMARCA2 shift by Prelude enshrouds Foghorn
Clinical
Just as investors were looking ahead to news by year-end on Prelude Therapeutics Inc.’s SMARCA2-targeted degraders, the firm said work in the space will be halted, with efforts shifting toward the mutant selective JAK2V617F JH2 inhibitor program by way of a new deal with Incyte Corp.

Financings

Azalea exits stealth to develop its in vivo gene engineering technology
Newco news
San Francisco Bay Area researchers from UC Berkeley, UC San Francisco and Stanford University have combined their technologies to create Azalea Therapeutics Inc., a company focused on editing cells in vivo.

Science

Trump’s MFN price deals a wake-up call for governments in Europe
Europe
The industry has been complaining about the drug pricing and reimbursement policies of European governments for years, but only now with the Trump administration’s moves to enforce most favored nation (MFN) pricing and reduce the U.S./EU price gap are governments facing up to the reality that they...

UK launches strategy to replace animals in research as scientists voice concern
Drug design, drug delivery and technologies
The U.K. government has published a road map for phasing out animal testing in life sciences research and announced £75 million (US$98.6 million) for work to develop nonanimal models, leaving scientists concerned because they say, in many cases, there can never be meaningful alternatives to using...
Ulipristal reprograms breast tissue, cutting cancer-prone cells
Cancer
Blocking progesterone receptor (PR) activity has long been viewed as a possible approach to breast cancer prevention. Historically, most supporting evidence came from animal models, epidemiological studies or mechanistic pathway analyses. Now, a team at the University of Manchester has uncovered...

Newco news

Signet builds new model for gastric cancer drug discovery
Cancer
Signet Therapeutics founder Haisheng Zhang is betting on organoids and AI to outsmart diffuse gastric cancer and the limits of traditional “clean” drug design.
Flagship Pioneering launches Expedition to advance covalent-binding drugs
Financings
Expedition Medicines, which Flagship Pioneering Inc. has incubated for the past three years, came out of stealth mode with a $50 million commitment from Flagship to support Expedition’s platform technology to discover small molecules that covalently bind to their target.
Flagship Pioneering launches Expedition to advance covalent-binding drugs
Financings
Expedition Medicines, which Flagship Pioneering Inc. has incubated for the past three years, came out of stealth mode with a $50 million commitment from Flagship to support Expedition’s platform technology to discover small molecules that covalently bind to their target.
Elevara raises $70M for phase II trial of CDK4/6 inhibitor in RA
Financings
Newco Elevara Medicines Ltd. has raised $70 million in a series A to fund a phase IIa/IIb trial of ELV-001, a first-in-class, oral cyclin dependent kinase 4/6 inhibitor, in the treatment of rheumatoid arthritis (RA) patients who do not have an adequate response to methotrexate and anti-TNF biologic...
SK Bio, Eurofarma launch Mentis Care for digital epilepsy care
Artificial intelligence
SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.

U.S.

MASH prospects from Rivus, Metavia show promise in phase II
Clinical
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.

Europe

Bavarian Nordic shareholders say no to private equity takeover
Vaccine
Bavarian Nordic A/S will continue operating as an independent public company after an offer to be acquired by two private equity firms failed to win sufficient shareholder approval.

Vesper's oral frontotemporal dementia drug positive in phase Ib/II
Clinical
Neurodegeneration specialist Vesper Bio ApS has announced positive results from the phase Ib/II trial of its oral sortilin inhibitor VES-001 in frontotemporal dementia. The small study involved six participants who had not progressed to symptomatic disease but were carriers of mutations in the GRN...
Angelini signs $550M deal for Sovargen’s ASO drug in epilepsy
Deals and M&A
Sovargen Co. Ltd. inked a $550 million license deal with Angelini Pharma SpA, granting Angelini development and commercialization rights to SVG-105, a novel antisense oligonucleotide drug candidate in preclinical development as a potential treatment for intractable epilepsy.

Clinical

Advancell sets new radiopharma standard in prostate cancer
Cancer
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.
Stock turns sharply higher with Terns’ leukemia data
Cancer
Early stage data from Terns Pharmaceuticals Inc.’s lead candidate showed a large reduction in the number of leukemia cells in those with previously treated chronic myeloid leukemia. Results from the ongoing phase I Cardinal study of TERN-701, an...
On the Climb in IgAN; Vera well done?
Analysis and data insight
Vera Therapeutics Inc.’s atacicept gained still more airtime at the Cantor Fitgerald health care conference held Sept. 4, and some on Wall Street believe the appetite for the BAFF and APRIL dual inhibitor could bode well for others in the same...
Wave, Ibio activin E action in obesity early but solid
Endocrine/metabolic
The activin E mechanism of action in obesity is having something of an early stage heyday with such players as Wave Life Sciences Ltd. and Ibio Inc. talking up data that have perked the ears of Wall Street.
Lumosa’s stroke drug meets phase IIb endpoints in China
Neurology/psychiatric
Lumosa Therapeutics Co. Ltd.’s intravenous odatroltide (LT-3001) met the primary endpoints in a phase IIb trial in China in patients with acute ischemic stroke, paving the way for a pivotal phase III study.
Amen at AANEM: Kyverna makes good on MG phase II promise
Conferences
Shooting for further proof of durable, drug-free, disease-free remission with a single dose of KYV-101 in generalized myasthenia gravis, Kyverna Therapeutics Inc. plans to start phase III work by the end of this year. The Emeryville, Calif.-based...

podcast microphone, sound waves on purple background Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.

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