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

October 8, 2024 8:30 AM EDT

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 Divisions review team will continue to... More