TSC-101 Achieves Complete Donor Chimerism in 93% of AML Patients in Phase 1
TSC-101 achieves complete donor chimerism in 93% of AML patients in Phase 1, with manufacturing success rate at 90%...
Atsena’s ATSN-201 Gene Therapy Enrolls Rapidly in Phase 3 Trial for X-Linked Retinoschisis
ATSN-201 gene therapy enrolls 10% of its 76-patient Phase 3 trial within weeks, targeting BLA filing in late 2028...
Boehringer Ingelheim launches three Phase III trials for obrixtamig and zongertinib
Boehringer Ingelheim launches three Phase III trials for obrixtamig and zongertinib across neuroendocrine carcinoma and HER2-mutant NSCLC.
Regeneron’s Cemdisiran Accepted for FDA Review in Generalized Myasthenia Gravis
Regeneron's cemdisiran accepted for FDA review in generalized myasthenia gravis, targeting November 2026 action date via Priority Review Voucher.
FDA Grants Breakthrough Therapy Designation to Elsunersen for SCN2A Epilepsy
FDA grants Breakthrough Therapy Designation to elsunersen for SCN2A epilepsy, based on 77% sham-adjusted seizure reduction in Phase 1/2...
MoonLake’s Sonelokimab Achieves 67% HiSCR75 Response in Phase 3 HS Trial
MoonLake's sonelokimab Phase 3 HS trial shows 67% of adults achieved HiSCR75 response at one year, with a third...
Rezolute’s Ersodetug Misses Congenital Hyperinsulinism Primary Endpoint
Rezolute's ersodetug missed its primary endpoint in congenital hyperinsulinism Phase 3, though expanded access data shows promise in tumor-driven...
Connect Biopharma Completes Enrollment in Rademikibart Asthma Study
Connect Biopharma completes enrollment in rademikibart asthma study testing single-dose IL-4Rα antibody during acute exacerbations, with topline data expected...
Teva Submits NDA for Ecopipam in Pediatric Tourette Syndrome
Teva submits NDA for ecopipam in pediatric Tourette syndrome, introducing a D1 receptor antagonist mechanism after a decade without...
Zabopegdutide Shows 81.8% Fibrosis Response in Phase 2 MASH Trial
Zabopegdutide demonstrates 81.8% fibrosis response in Phase 2 MASH trial, with AI pathology analysis confirming 41% relative reduction in...