Brief: Soleno Therapeutics Announces FDA Extension Of Review Period For DCCR

Soleno Therapeutics

26/11/2024 13:43

Nov 26 (Reuters) - Soleno Therapeutics Inc  SLNO.O :
    * SOLENO THERAPEUTICS ANNOUNCES FDA EXTENSION OF REVIEW
PERIOD FOR
DCCR (DIAZOXIDE CHOLINE) EXTENDED-RELEASE TABLETS IN
PRADER-WILLI SYNDROME
    * SOLENO THERAPEUTICS INC - NEW PDUFA TARGET ACTION DATE SET
FOR
MARCH 27, 2025
    * SOLENO THERAPEUTICS INC - FDA DID NOT CITE SAFETY,
EFFICACY OR
MANUFACTURING CONCERNS
    * SOLENO:  FDA DETERMINED THAT RESPONSES TO RECENT
INFORMATION
REQUESTS CONSTITUTED A MAJOR AMENDMENT TO NDA FOR DCCR
EXTENDED-RELEASE TABLETS

Source text:  ID:nGNX5Bvphq 
Further company coverage:  SLNO.O 

 ((Reuters.Briefs@thomsonreuters.com;))