MarketPulse

FDA Priority Review

3 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Aicuris Wins FDA Priority Review for First HSV Treatment in 20+ Years

Aicuris receives FDA Priority Review for pritelivir, a novel herpes simplex virus treatment. Phase 3 data shows 82.4% healing rate; PDUFA decision expected Q4 2026.
AHKSYPhase 3 trialPDUFA
GlobeNewswire Inc.GlobeNewswire Inc.··Priovant Therapeutics / Roivant Sciences

Priovant's Brepocitinib Clears Phase 3 Trial for Rare Muscle Disease, Eyes 2026 FDA Approval

Priovant's brepocitinib met Phase 3 endpoints for dermatomyositis treatment, earning FDA Priority Review with Q3 2026 decision expected.
ROIVclinical trial resultsautoimmune disease
GlobeNewswire Inc.GlobeNewswire Inc.··Celcuity Inc.

Celcuity's Gedatolisib Shows 76% Risk Reduction in Breast Cancer Trial

Celcuity's gedatolisib achieved 76% risk reduction in advanced breast cancer with PIK3CA wild-type mutations; FDA Priority Review decision expected July 2026.
CELCPhase 3 trialprogression-free survival