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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...
FDA signals wider use of real‑world data — calls for early‑phase reform
FDA Commissioner Marty Makary told a Wall Street audience the agency will consider more real‑world data (RWD) in drug and device applications, including large de‑identified datasets, and...
Kyverna’s CAR-T wins pivotal readout — FDA filing planned
Kyverna Therapeutics reported that its patient-specific CD19 CAR-T therapy achieved statistically significant benefits in a registrational trial for stiff person syndrome (SPS), meeting the...
Chai Discovery raises $130M — valuation tops $1.3B
Chai Discovery closed a $130 million Series B led by Oak HC/FT and General Catalyst, bringing the AI-native drug developer’s valuation to roughly $1.3 billion. The company said it will deploy the...
Sobi buys Arthrosi for $950M upfront — deal could reach $1.45B
Swedish drugmaker Sobi agreed to acquire Arthrosi Therapeutics for $950 million in cash with up to $550 million in clinical, regulatory, and sales milestones to add pozdeutinurad (AR882), a Phase...
Sanofi’s MS gamble falters: Phase 3 miss and regulatory delay
Sanofi disclosed setbacks for tolebrutinib, the BTK inhibitor it acquired for about $3.7 billion: a Phase 3 trial in primary progressive multiple sclerosis failed to meet its endpoints, and a...
Adaptive licenses TCR tech to Pfizer — pact could top $890M
Adaptive Biotechnologies struck two non-exclusive agreements with Pfizer to apply Adaptive’s T-cell receptor (TCR) discovery platform to rheumatoid arthritis R&D and to license TCR-antigen mapping...
Child death in brain-virus trial rattles gene therapy field
A fatality in the first patient dosed with a brain-penetrant viral vector developed by Capsida Biotherapeutics has unsettled researchers and companies working on gene therapies that cross the...
Immunome’s rare-tumor drug posts Phase 3 victory — FDA bid ahead
Immunome reported that its antibody reduced the risk of disease worsening or death by 84% in a Phase 3 trial for advanced desmoid tumors, achieving the study’s primary endpoint. The company said...
Areteia winds down after late‑stage asthma terminations
Areteia Therapeutics is winding down after terminating its Phase 3 asthma studies, the company said via sources. Executives have exited and development activity is being halted, ending one of the...
Milestone wins FDA approval: nasal spray for PSVT cleared
Milestone Pharmaceuticals secured FDA approval for Cardamyst (etripamil), a nasally administered treatment for paroxysmal supraventricular tachycardia (PSVT), after earlier regulatory setbacks....
Palvella posts positive Phase 2 for rapamycin gel in pediatric skin disease
Palvella Therapeutics said its 3.9% topical rapamycin gel produced clinical improvements in a mid-stage trial for a rare pediatric skin disease, reporting positive Phase 2 data. The company...
Sobi buys Arthrosi: $950m upfront to lock in Phase‑3 gout asset
Sobi agreed to acquire Arthrosi Therapeutics for $950 million in cash with up to $550 million in milestones, securing pozdeutinurad (AR882), a Phase‑3 URAT1 inhibitor for progressive gout. The...
Argenx halts Vyvgart Hytrulo trials: interim review finds low chance of success
Argenx reported that an independent data monitoring committee recommended stopping late‑stage trials of Vyvgart Hytrulo in thyroid eye disease after an interim analysis concluded the studies were...
Sanofi’s BTK candidate fails Phase 3 – regulatory timeline slips
Sanofi disclosed that its BTK inhibitor tolebrutinib failed Phase‑3 trials in multiple sclerosis after missing endpoints in two different disease forms, prompting the company to reassess...
Chai Discovery raises $130m Series B... valuation at $1.3bn
Chai Discovery closed a $130 million Series B round at a $1.3 billion valuation, extending the rapid funding trajectory of the AI‑driven biotech founded in 2024. The financing was led by growth...
Child death after brain‑directed gene therapy: Capsida trial under scrutiny
A report in STAT detailed the sudden death of a child two and a half days after receiving an experimental brain‑directed gene therapy, triggering concern across academic and commercial...