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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...
Adaptive’s immune data deal set — Pfizer licenses TCR tech and data access
Adaptive Biotechnologies signed two non‑exclusive agreements with Pfizer to license its T‑cell receptor discovery platform and large TCR‑antigen mapping datasets for rheumatoid arthritis and...
Immunome’s phase‑3 win: desmoid tumor drug cuts progression risk 84%
Immunome reported positive top-line Phase III results for varegacestat in progressing desmoid tumors, showing a statistically significant and clinically meaningful improvement in progression‑free...
Kyverna’s CAR‑T for autoimmune disease nears FDA filing after pivotal readout
Kyverna Therapeutics reported registrational‑trial results showing its patient‑specific CD19 CAR‑T improved mobility and stiffness in stiff person syndrome (SPS), meeting primary and secondary...
Sobi buys Arthrosi for $950M up front to bulk up gout pipeline
Sweden’s Sobi agreed to acquire Arthrosi Therapeutics for $950 million in cash, plus up to $550 million in milestones, to add pozdeutinurad — a once‑daily URAT1 inhibitor in global Phase III...
XOMA Royalty to acquire Generation Bio — adds ctLNP royalties and Moderna upside
XOMA Royalty entered an agreement to acquire Generation Bio for $4.2913 per share in cash and to issue contingent value rights tied to net cash, lease savings and potential milestone/royalty...
Chai Discovery raises $130M Series B to scale AI drug design — valuation $1.3B
Chai Discovery closed a $130 million Series B led by Oak HC/FT and General Catalyst, valuing the AI‑driven drug‑design company at $1.3 billion. The round follows a recent Series A and accompanies...
FDA clears Enhertu first‑line combo and broadens Roche HER2 assays for patient ID
The FDA approved AstraZeneca/Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for first‑line unresectable or metastatic HER2‑positive breast cancer and expanded...
Sanofi’s tolebrutinib program hits setbacks: phase‑3 miss and U.S. review delay
Sanofi reported that the Phase III Perseus study of BTK inhibitor tolebrutinib failed to meet its primary endpoint in primary progressive multiple sclerosis (PPMS), and the company warned that the...
NIH gives $40M to Vitalex/Lundquist to advance dual‑antigen fungal vaccine into Phase I
The NIH/NIAID awarded up to $40 million to Vitalex Biosciences and collaborator The Lundquist Institute to advance VXV‑01, a second‑generation dual‑antigen vaccine targeting Candida spp. and key...
Adaptive signs multi‑deal with Pfizer to license TCR discovery tech and antigen maps
Adaptive Biotechnologies struck two non‑exclusive agreements with Pfizer to license its T‑cell receptor discovery platform and TCR‑antigen mapping data for immune target discovery and AI model...