Benzinga | Dec 11, 2020 08:32AM EST

Soleno Therapeutics Announces Receipt Of Type C Meeting Minutes With FDA; Says 'confirmed the discussion with the FDA regarding the potential adequacy of data from completed and ongoing studies with DCCR'

REDWOOD CITY, Calif., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ("Soleno") (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the receipt of official meeting minutes from the November 12, 2020, Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily Diazoxide Choline Controlled Release (DCCR) tablets for the treatment of Prader-Willi Syndrome (PWS). The meeting minutes confirmed the discussion with the FDA regarding the potential adequacy of data from completed and ongoing studies with DCCR, together with external, natural history studies to support a New Drug Application (NDA) for DCCR for the treatment of PWS. Soleno intends to submit formal plans for these analyses, which the FDA has stated it is committed to reviewing.



"We appreciate the guidance provided by the FDA and are finalizing our plans to conduct the analyses that were discussed at this meeting and look forward to submitting them to the FDA," said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. "While we hope that these data, together with the additional analyses, will suffice as adequate for an NDA, we cannot, at this time, exclude the possibility that the FDA will require us to conduct an additional controlled clinical study. We look forward to working with the FDA to ensure that the necessary data and information are compiled for the NDA, which we are currently preparing to submit in the second half of 2021."