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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...
Structure’s oral GLP‑1 soars — Phase II weight loss fuels 100% stock rally
Structure Therapeutics reported positive Phase II ACCESS results for aleniglipron, an oral GLP‑1 candidate, triggering a >100% jump in its share price. The company disclosed placebo‑adjusted...
Laguna Bio bets engineered Listeria on pediatric leukemia: living drug nears clinic
Laguna Bio unveiled a therapeutic strategy that engineers a highly attenuated Listeria monocytogenes strain to activate multifaceted immune responses—targeting gamma delta T cells—and announced...
Fertility gene PRDM9 helps glioblastoma resist chemo — blocking it clears persisters
Researchers at the University of Sydney reported that glioblastoma persister cells co‑opt the fertility gene PRDM9 to produce cholesterol that enables survival during chemotherapy. The Nature...
Open‑source platform speeds drug‑combination discovery: cell‑level screening unveiled
Researchers published an open‑source screening platform in Nature Communications that accelerates identification of synergistic drug combinations across cellular models. The platform integrates...