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Sanofi’s BTK setback: tolebrutinib misses trials and review stalls
Sanofi disclosed that its BTK inhibitor tolebrutinib failed a Phase III Perseus study in primary progressive multiple sclerosis (PPMS) and warned that the U.S. regulatory review in non‑relapsing...
Chai Discovery raises $130M: AI antibody design scales to clinic
AI drug discovery startup Chai Discovery closed a $130 million Series B led by Oak HC/FT and General Catalyst at a $1.3 billion valuation to expand its computational design platform. The company...
DBV’s peanut patch clears Phase 3: another FDA resubmission ahead
DBV Technologies announced Phase III success for its epicutaneous peanut allergy patch in a trial enrolling more than 650 children, a milestone that sets the company up for another FDA submission...
Nektar’s rezpegaldesleukin: narrow miss, company blames enrollment errors
Nektar reported that rezpegaldesleukin narrowly missed statistical significance in its Phase 2b Rezolve‑AA trial for severe alopecia areata but said post‑hoc analyses excluding four ineligible...
Pfizer licenses Adaptive’s TCR tech: up to $890M in upside
Adaptive Biotechnologies signed two multi‑year agreements with Pfizer to license its T‑cell receptor (TCR) discovery platform and TCR‑antigen mapping data. Under the first agreement, Pfizer will...
Enhertu first-line approval: FDA clears combo for HER2 metastatic patients
The FDA granted a label expansion for Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan), clearing the antibody-drug conjugate for use in combination with pertuzumab as a first-line...
Genentech-Caris deal: $1.1B collaboration to mine solid‑tumor targets
Roche subsidiary Genentech struck a multi‑year discovery collaboration with Caris Life Sciences to identify drug targets in solid tumors. The pact includes upfront and near‑term payments to Caris...
XOMA moves on Generation Bio: royalty aggregator targets delivery platform
XOMA Royalty announced a planned acquisition of Generation Bio, offering roughly $4.29 per share and contingent value rights tied to cash and milestone streams from Generation Bio’s...
Kyverna’s CAR‑T clears registrational test: path to FDA submission
Kyverna Therapeutics reported positive registrational‑scale results for its autologous CD19 CAR‑T in stiff person syndrome (SPS), an autoimmune neurological disorder with no approved therapies....
Immunome’s Phase III win: oral drug cuts desmoid progression by 84%
Immunome announced top‑line Phase III results showing its oral gamma‑secretase inhibitor produced an 84% reduction in the risk of disease progression or death versus placebo in progressing desmoid...
Sobi buys Arthrosi: $950M upfront to broaden gout portfolio
Swedish drugmaker Sobi agreed to acquire Arthrosi Therapeutics for $950 million upfront, with up to $550 million in additional milestones tied to pozdeutinurad’s Phase III progress and commercial...
Chai Discovery raises $130M: AI‑native drug design scales up
AI drug design firm Chai Discovery closed a $130 million Series B at a $1.3 billion valuation to scale its computational platform, including the recently released Chai 2 model for antibody design....
Pfizer doubles down on weight‑loss market: 15 obesity studies planned
Pfizer disclosed plans to launch 15 new studies in obesity next year, including multiple Phase III programs, as it seeks to shore up revenue facing a looming patent cliff. The initiative signals...
mRNA precision moves: tumor‑selective SMRTS and organ‑targeted BiTEs advance
Two preclinical advances highlight growing sophistication in mRNA therapeutics. A team reported a tumor‑selective modified RNA translation system (SMRTS) that programs mRNA to activate therapeutic...
FDA urges RWD use and early‑phase reform: regulator seeks modern inputs
FDA Commissioner Martin Makary told a Wall Street audience the agency will increase consideration of real‑world data in regulatory decisions and reiterated calls to modernize early‑phase clinical...
Ambros Therapeutics launches with $125M — pain drug heads to U.S.
Ambros Therapeutics announced its launch with a $125 million financing and plans to run a Phase 3 trial of neridronate, an agent licensed from Italy’s Abiogen Pharma, to treat complex regional...
XOMA Royalty to acquire Generation Bio — tender offer includes CVR upside
XOMA Royalty Corporation agreed to acquire Generation Bio in a cash tender offer at $4.2913 per share, adding Generation Bio’s cell‑targeted lipid nanoparticle (ctLNP) delivery platform to XOMA’s...
Sanofi doubles down on Alzheimer’s and tau: $80M upfront ADEL license
Sanofi licensed ADEL’s tau‑targeting candidate ADEL‑Y01 for $80 million upfront, taking global rights to a South Korean biotech’s anti‑tau program. The deal follows a second Sanofi Alzheimer’s...
Sobi to buy Arthrosi for $950M upfront — pozdeutinurad heads toward Phase 3 readouts
Swedish pharma Sobi agreed to acquire Arthrosi Therapeutics for $950 million in cash with up to $550 million in milestones, targeting Arthrosi’s Phase 3 URAT1 inhibitor pozdeutinurad (AR882) for...
Immunome’s oral desmoid drug cuts progression risk 84% — Phase 3 win sets up NDA
Immunome reported positive topline Phase 3 results for its oral gamma‑secretase inhibitor (varegacestat), showing an 84% reduction in the risk of progression or death in patients with progressing...