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Brain‑penetrant gene therapy safety questioned after child’s fatal outcome — field reassesses risk
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
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
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
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
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
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
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
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...
SMRTS engineered mRNA switches on in tumors only – precision mRNA shows preclinical selectivity
Researchers published a Molecular Therapy paper describing SMRTS (selective modified RNA translation system), an engineered mRNA approach that activates therapeutic genes in tumor cells while...
NIH awards $40M to Vitalex/Lundquist for VXV‑01 fungal vaccine—Phase I prep under way
The NIH/NIAID awarded up to $40 million in non‑dilutive funding to Vitalex Biosciences and the Lundquist Institute to advance VXV‑01, a second‑generation dual‑antigen fungal vaccine targeting...
Adaptive licenses TCR tech and data to Pfizer – big‑ticket pact to accelerate immunology R&D
Adaptive Biotechnologies struck two non‑exclusive agreements with Pfizer: one to apply Adaptive’s T‑cell receptor (TCR) discovery platform to Pfizer clinical samples for rheumatoid arthritis...
Enhertu cleared for first-line use — Roche HER2 tests broaden access
The FDA granted a first-line label expansion for AstraZeneca and Daiichi Sankyo’s Enhertu, clearing the antibody-drug conjugate for use in adults with unresectable or metastatic HER2-positive...
Immunome’s oral desmoid therapy slashes progression risk — Phase III win
Immunome reported Phase III data showing its investigational oral therapy reduced the risk of disease worsening or death by 84% versus placebo in progressing desmoid tumors. The company described...
Kyverna’s CAR‑T for a rare autoimmune disease heads to FDA — registrational success
Kyverna Therapeutics announced pivotal-trial results in stiff person syndrome (SPS) that met the study’s primary and all secondary endpoints, prompting plans for a U.S. filing in the first half of...
Sobi pays $950M upfront for Arthrosi — bolsters gout pipeline
Sweden’s Sobi agreed to acquire Arthrosi Therapeutics for $950 million cash upfront plus up to $550 million in milestones to add pozdeutinurad (AR882), a Phase III oral URAT1 inhibitor, to its...
Chai Discovery raises $130M — AI antibody design scales up
AI-native drug developer Chai Discovery closed a $130 million Series B at a $1.3 billion valuation to accelerate its computational platform for therapeutic design. The financing, led by Oak HC/FT...
Gilead posts second Phase III win for new HIV regimen — non‑inferior to Biktarvy
Gilead announced a second positive Phase III trial showing its two‑drug regimen achieved non‑inferiority versus the established triple therapy Biktarvy. The result advances Gilead’s bid to offer...
Sanofi’s BTK hopes stumble: Phase III miss and U.S. review delay
Sanofi reported that Perseus, a Phase III study of its BTK inhibitor tolebrutinib in primary progressive multiple sclerosis, failed to meet its primary endpoint. The company also warned the U.S....
Mass General Brigham spins out generative AI startup to speed trial screening
Mass General Brigham launched a commercial spinout delivering a generative AI platform that interprets structured and unstructured clinical data to accelerate patient screening for clinical...
Adaptive inks deals with Pfizer — TCR licensing and data access for autoimmune R&D
Adaptive Biotechnologies signed two non‑exclusive agreements with Pfizer to license its T‑cell receptor discovery platform and TCR‑antigen mapping data. Under the first deal Adaptive will apply...