Brief: U.S. FDA Grants Priority Review For Roche’S Enspryng For Mogad
10/09/2026 06:02
BRIEF-U.S. FDA Grants Priority Review For Roche’S Enspryng For Mogad Sept 10 (Reuters) - ROCHE HOLDING AG ROPC.S:
U.S. FDA GRANTS PRIORITY REVIEW FOR ROCHE’S ENSPRYNG FOR MOGAD, AN AUTOIMMUNE DISEASE WITH NO APPROVED TREATMENTS
FILING ACCEPTANCE IS BASED ON PHASE III METEOROID STUDY SHOWING THAT ENSPRYNG REDUCED RISK OF RELAPSES BY 68%
FDA IS EXPECTED TO MAKE A DECISION ON APPROVAL IN MOGAD BY 10 JANUARY 2027
ADDITIONALLY, EUROPEAN MEDICINES AGENCY (EMA) HAS VALIDATED APPLICATION FOR ENSPRYNG FOR MOGAD IN EUROPE
DECISION BY EUROPEAN COMMISSION IS EXPECTED IN Q3 OF 2027
Source text: ID:nGNE7n4LyB
Further company coverage: ROPC.S
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