Get the Daily Brief
Latest Biotech News
BioNTech and Duality advance B7‑H3 ADC into phase 3 — lean trial design
BioNTech and partner DualityBio announced plans to move their B7‑H3–targeting antibody‑drug conjugate into a phase‑3 study for metastatic castration‑resistant prostate cancer after encouraging...
Caris Detect interim data: ctDNA signals support MCED launch
Caris Life Sciences released interim results from the Achieve 1 validation study showing its Caris Detect multicancer early detection (MCED) assay delivered stage‑dependent sensitivity and high...
PMV’s rezatapopt validates p53 reactivation: NEJM reports responses
PMV Pharmaceuticals published Phase I results of rezatapopt — a small molecule designed to reactivate mutant p53 (TP53 Y220C) — in the New England Journal of Medicine. The first‑in‑human study...
Systimmune’s iza‑bren hits primary endpoints in China phase 3 — survival gains
Systimmune reported that izalontamab brengitecan (iza‑bren), developed under license by Bristol Myers Squibb in China, met both progression‑free survival and overall survival endpoints in a...
Boehringer wins accelerated approval: Hernexeos cleared for first‑line lung use
The FDA expanded the label for Boehringer Ingelheim’s lung cancer drug Hernexeos under a National Priority Voucher pathway, granting an accelerated review and approval for first‑line use in...
Makary defends FDA rejections — rare‑disease stocks wobble as UniQure slides
FDA Commissioner Marty Makary publicly defended recent agency decisions to reject several rare‑disease therapies, citing cases where clinical benefit was not demonstrated and pushing back against...
Moderna’s combo vaccine clears EU hurdle: CHMP backs mCombriax
The European Medicines Agency’s human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza–COVID-19 mRNA vaccine, bringing the product one step from EU...
FDA trial rule shift… global ripple expected
The U.S. Food and Drug Administration signaled a policy shift toward allowing marketing authorizations based on a single adequate, well‑controlled trial as a default — a move agency leaders said...
Generate Biomedicines raises $400M: AI design funds pivotal asthma trials
Generate Biomedicines priced a landmark IPO, raising roughly $400 million to advance its AI‑designed pipeline and fund pivotal phase 3 trials for its anti‑TSLP antibody GB‑0895 in severe asthma....
Systimmune’s iza‑bren passes China phase III endpoints — survival gains reported
Systimmune reported that izalontamab brengitecan (iza‑bren) met both progression‑free survival and overall survival endpoints in a phase III trial in Chinese patients with advanced triple‑negative...
Caris Detect interim readout: ctDNA‑guided MCED shows stage‑dependent sensitivity
Caris Life Sciences unveiled interim validation results from its Achieve 1 study supporting the planned commercial launch of Caris Detect, a multicancer early detection (MCED) blood assay. In...
Atrium rises from Avidity sale – $270M spinout to pursue cardiac RNA programs
Atrium Therapeutics launched as a spinout preserving Avidity Biosciences’ cardiac RNA programs after Novartis closed its $12 billion acquisition of Avidity. Led by former Avidity executives,...
Earendil inks up to $885M pact with WuXi XDC — ADC linker access secured
Earendil Labs struck an exclusive deal to access WuXi XDC’s WuXiTecan‑2 payload‑linker technology for next‑generation antibody‑drug conjugates, a transaction valued at up to $885 million in...
Asahi Kasei buys Aicuris for $920M — expands antiviral portfolio
Asahi Kasei agreed to acquire German antiviral specialist Aicuris for about $920 million, gaining marketed cytomegalovirus product Prevymis and late‑stage assets including pritelivir for herpes...
Regulator rhetoric rattles market — UniQure slides after FDA comments
UniQure’s market value plunged after FDA Commissioner Marty Makary defended recent rare‑disease therapy rejections on a public broadcast, prompting investor concerns that the agency’s stance could...
FDA proposes ‘plausible mechanism’ route — new framework for ultra‑rare therapies
The U.S. Food and Drug Administration proposed a draft ‘plausible mechanism’ framework to accelerate development of individualized and ultra‑rare therapies when randomized controlled trials are...
Earendil–WuXi XDC pact: $885M play for next‑gen ADC linkers
Earendil Labs signed an exclusive pact with WuXi XDC to license the WuXiTecan‑2 payload‑linker platform and tap WuXi XDC’s CRDMO capabilities to advance antibody‑drug conjugates (ADCs). The deal...
Atrium launches as Novartis closes $12B Avidity buyout
Novartis completed its $12 billion acquisition of Avidity Biosciences and simultaneously spun out Atrium Therapeutics to carry forward Avidity’s early cardiac RNA programs. Atrium launched with...
Generate prices $400M IPO: AI drug discovery lists on Nasdaq
Generate:Biomedicines priced a $400 million Nasdaq IPO, selling 25 million shares at $16 apiece and positioning proceeds to fund two phase 3 asthma trials for its anti‑TSLP antibody GB‑0895 and to...
Caris Detect interim: MCED assay posts high specificity, stage‑linked sensitivity
Caris Life Sciences released interim Achieve‑1 validation data for Caris Detect, its multicancer early detection (MCED) blood test, reporting approximately 95% specificity in 1,505 undiagnosed...