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Latest Biotech News

Tumor‑selective mRNA: engineered SMRTS switches on therapy only in cancer cells

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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%

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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

December 16, 2025

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...

Brain‑penetrant gene therapy safety questioned after child’s fatal outcome — field reassesses risk

December 16, 2025

A fatal adverse event in the first human dosed with a newly engineered brain‑penetrant viral vector has raised safety concerns across gene‑therapy programs aimed at delivering treatments to the...

Immunome’s oral desmoid drug slashes progression risk – Phase III wins set up FDA filing

December 16, 2025

Immunome reported positive top-line Phase III results for its oral gamma secretase inhibitor varegacestat, showing an 84% reduction in the risk of disease progression or death versus placebo in...

Sanofi’s BTK program stumbles: Phase III miss and U.S. review delay

December 16, 2025

Sanofi’s Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib failed to meet the primary endpoint in the Perseus Phase III trial for primary progressive multiple sclerosis and faces a delayed...

Sobi shells out $950M to buy Arthrosi – pozdeutinurad bolsters gout pipeline

December 16, 2025

Swedish drugmaker Sobi agreed to acquire Arthrosi Therapeutics for $950 million upfront, with up to $550 million in additional milestones, to add pozdeutinurad (AR882), a Phase III URAT1 inhibitor...

Kyverna’s CAR‑T posts pivotal gains in stiff person syndrome – FDA filing eyed

December 16, 2025

Kyverna Therapeutics reported positive pivotal data for its patient‑specific CD19 CAR‑T therapy in stiff person syndrome (SPS), showing statistically significant benefit on the trial’s primary and...

FDA clears Enhertu first‑line combo; Roche assays broaden patient ID

December 16, 2025

The FDA expanded the label for AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) to include use with pertuzumab as a first‑line treatment for unresectable or metastatic...

XOMA Royalty moves to buy Generation Bio – ctLNP platform and Moderna ties included

December 16, 2025

XOMA Royalty Corporation announced an agreement to acquire Generation Bio for $4.2913 per share in cash and contingent value rights (CVRs) that could deliver further payments tied to cash, lease...

Chai Discovery raises $130M Series B at $1.3B valuation – AI antibody design scales up

December 16, 2025

AI drug‑discovery startup Chai Discovery closed a $130 million Series B led by Oak HC/FT and General Catalyst, valuing the company at about $1.3 billion. The round follows a recent Series A and...