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Stock impact report

Soleno Therapeutics Announces Regulatory Update on DCCR (diazoxide choline) Extended-Release Tablets to Treat Prader-Willi Syndrome

Soleno Therapeutics, Inc. (SLNO) 
Last soleno therapeutics, inc. earnings: 5/13 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: investors.soleno.life/investor-overview
Company Research Source: GlobeNewswire
REDWOOD CITY, Calif., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a regulatory update from the U.S. Food and Drug Administration (FDA). The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS).  However, the Division’s review team will continue to consider the potential need for an advisory committee meeting during their ongoing review. As announced previously, the DCCR NDA was designated for Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024. About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The h Show less Read more
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