FDA extends PDUFA date for Soleno's DCCR NDA to March 27, 2025

SOLENO THERAPEUTICS INC

FDA extended review period by three months from Dec 27, 2024, to March 27, 2025.
Extension due to FDA deeming responses to recent info requests a major amendment.
FDA did not cite any safety, efficacy, or manufacturing concerns in correspondence.
NDA for DCCR to treat hyperphagia in Prader-Willi syndrome patients aged 4+.
DCCR has Breakthrough, Fast Track, and Orphan Drug designations in US and EU.

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