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Atrium launches with $270M – Avidity cardiac RNA programs continue
Atrium Therapeutics launched as a spinout from Avidity Biosciences after Novartis closed its acquisition, taking on cardiovascular RNA programs and a $270 million cash position. The new company...
Earendil inks up to $885M ADC pact with WuXi XDC
AI‑driven biologics developer Earendil Labs secured an exclusive license to WuXi XDC’s WuXiTecan‑2 payload‑linker technology to develop next‑generation antibody‑drug conjugates (ADCs), in a deal...
CHMP recommends three orphan drugs; rebuffs two FDA‑approved programs
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for three new orphan medicines and declined to endorse two programs previously cleared by the...
U.S. launches probe into Chinese biotech support – ITC examines pricing
U.S. authorities opened an investigation into Chinese state support and pricing practices in the biotech sector, flagging potential market manipulation that could disadvantage American firms....
Rezatapopt shows clinical activity in TP53 Y220C tumors – NEJM report
PMV Pharmaceuticals published Phase I data in the New England Journal of Medicine showing clinical activity for rezatapopt, a small molecule designed to reactivate mutant p53 in tumors bearing the...
Ultra‑sensitive CAR‑T advances: HIT receptors and NR2F6 deletion boost potency
Two independent preclinical advances aim to tackle the core challenge of applying cell therapy to solid tumors. Columbia University researchers reported in Science that HLA‑independent T (HIT)...
Roche details Axelios sequencer: $150 per human genome claim
At AGBT Roche provided technical and commercial details for its Axelios 1 sequencing platform, touting a $150 list cost to sequence a human genome at 30× coverage in duplex mode. The company...
FDA trial default and political defense collide — one trial standard questioned
The FDA’s move to adopt a default of relying on one adequate, well‑controlled trial for marketing authorization is provoking industry debate about global consequences and payer expectations. A New...
Generate Biomedicines IPO: $400M to fund phase‑3 TSLP push
Generate Biomedicines priced a $400 million IPO to bankroll pivotal trials of its anti‑TSLP antibody and expand its AI‑driven protein design platform. The Flagship Pioneering‑backed company sold...
EMA recommends Moderna’s flu–COVID combo: mCombriax nears EU clearance
European regulators’ human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID‑19 mRNA vaccine for people aged 50 and older. The CHMP concluded...
Atrium Therapeutics rises from Avidity: $270M, cardiac RNA programs
Atrium Therapeutics launched as a spinout carrying Avidity Biosciences’ cardiac RNA programs and the public listing formerly held by Avidity after Novartis completed its $12 billion acquisition....
WuXi XDC licenses ADC linker to Earendil — up to $885M pact
WuXi XDC signed an exclusive licensing and CRDMO agreement with AI‑driven biologics developer Earendil Labs giving Earendil access to the WuXiTecan‑2 payload‑linker technology to build...
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...