Oral semaglutide showed 21.6% weight loss in early responders, 77% mobility gains
Oral semaglutide showed 21.6% weight loss in early responders and 77% mobility gains in patients with obesity-related physical impairment.
When the Sponsor’s Name Changes Mid-Trial, Sites Pay the Operational Price
BioMarin's $4.8B Amicus acquisition closed April 27—now sites running Amicus trials face contract ownership gaps, monitoring voids, and enrollment...
Kyverna’s SPS CAR-T Therapy Advances to BLA Based on Natural History Study Data
Kyverna's SPS CAR-T Therapy advances to BLA submission based on natural history study data showing disease progression on existing...
Agios Seeks FDA Accelerated Approval for Mitapivat in Sickle Cell Disease
Agios pursues accelerated approval for mitapivat in sickle cell disease based on hemoglobin response, pending FDA review in Q3...
DIPG’s Biomarker Reckoning: What BIOMEDE Tells Us About Precision Oncology Trial Design When the Primary Endpoint Fails
BIOMEDE screened 279 DIPG patients across 45 centers using biopsy-driven tumor profiling — and its biomarker signals outlasted its...
Septerna’s SEP-631 Shows Dose-Dependent Skin Response in Phase 1 Urticaria Study
Septerna's SEP-631 demonstrates dose-dependent skin response in Phase 1 urticaria study, establishing mechanistic link to MRGPRX2 receptor occupancy in...
BioAge Labs Advances BGE-102 NLRP3 Inhibitor With Phase 2 Cardiovascular Trial
BioAge Labs advances BGE-102 NLRP3 inhibitor into Phase 2 cardiovascular trial after Phase 1 showed 86% median hsCRP reduction.
Actuate Advances Oral Elraglusib Into Phase 1/2 After FDA IND Clearance
Actuate advances oral elraglusib into Phase 1/2 after FDA IND clearance, targeting superior systemic exposure versus IV formulation.
MoonLake Gains FDA Clearance for Sonelokimab Hidradenitis Suppurativa Label
MoonLake's sonelokimab hidradenitis suppurativa treatment gains FDA clearance with the highest efficacy rates ever recorded in an adequate, well-controlled...
Intellia’s Lonvoguran Ziclumeran Cuts HAE Attacks 87% in Phase 3 Trial
Intellia's lonvoguran ziclumeran reduced HAE attacks 87% in Phase 3, with 62% of patients remaining attack-free for six months...