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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...
Kyverna’s autoimmune CAR‑T clears registrational hurdle — FDA filing planned
Kyverna Therapeutics said its patient‑specific CAR‑T therapy produced statistically significant and clinically meaningful benefits in a registrational trial for stiff person syndrome (SPS),...
FDA clears Enhertu for first‑line HER2+ disease — Roche tests expanded to match
The FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab as a first‑line treatment for unresectable or metastatic HER2‑positive breast...
Chai Discovery raises $130M Series B — AI models design antibody leads
AI drug developer Chai Discovery closed a $130 million Series B led by Oak HC/FT and General Catalyst at a $1.3 billion valuation to scale its computer‑aided design platform for therapeutics. The...
Child’s death after brain‑penetrant viral gene therapy rattles field
A STAT report detailed the death of the first patient dosed with a brain‑penetrant viral gene therapy, triggering concern across labs and companies developing vectors engineered to cross the...
FDA signals regulatory shifts — more real‑world data, faster reviews after positive readouts
FDA leadership said the agency will give greater weight to real‑world data in drug and device applications and is revisiting early‑phase trial reform to accelerate reliable evidence generation,...
Phase III shock: Immunome’s oral desmoid drug slashes progression
Immunome reported a decisive Phase III result showing its oral gamma secretase inhibitor dramatically reduced disease worsening in progressing desmoid tumors. The trial met its primary endpoint...
Autoimmune first: Kyverna’s CAR‑T shows registrational benefits — filing next
Kyverna disclosed registrational‑quality trial results for its CD19 CAR‑T in stiff person syndrome (SPS), showing statistically robust improvements in mobility and symptom endpoints. The company...
Sanofi’s BTK setback: tolebrutinib fails trial — U.S. decision delayed
Sanofi disclosed a Phase III failure for tolebrutinib in primary progressive multiple sclerosis (Perseus) and warned the FDA review for another indication will likely miss the targeted PDUFA date....
Sobi buys Arthrosi — $950M upfront to bolster gout franchise
Sweden’s Sobi agreed to acquire Arthrosi Therapeutics for $950 million in cash, with up to $550 million in milestones, to add pozdeutinurad — a Phase III URAT1 inhibitor — to its pipeline. Sobi...
FDA widens Enhertu use — diagnostics cleared to match the label
The FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for first‑line HER2‑positive metastatic breast cancer and cleared expanded claims...
Royalty buyer moves in: XOMA Royalty to acquire Generation Bio
XOMA Royalty announced an agreement to acquire Generation Bio for a fixed cash price per share plus contingent value rights tied to cash balances, lease savings, and potential milestone and...
Chai Discovery ups the ante: $130M Series B to scale AI drug design
AI drug developer Chai Discovery closed a $130 million Series B at a $1.3 billion valuation to expand its computational platform and molecule generation efforts. The company highlighted Chai 2,...
Tumor‑selective mRNA: engineered SMRTS switches on therapy only in cancer cells
Researchers published a tumor‑selective mRNA system (SMRTS) that encodes an internal decision logic enabling therapeutic gene translation in cancer cells while shutting off in healthy tissues. The...
Federal boost for fungal vaccine: $40M NIH award funds VXV‑01 Phase I work
The NIH/NIAID awarded up to $40 million to Vitalex Biosciences and The Lundquist Institute to advance VXV‑01, a dual‑antigen fungal vaccine targeting Candida species and key Gram‑negative...