FDA official announcements and press releases

Soleno's Prader-Willi Drug Gets FDA Priority Review, No AdCom; Stock Up 12% to 52-Week High

Oct 8, 2024, 06:14 PM

Soleno Therapeutics announced a regulatory update for its DCCR (diazoxide choline) Extended-Release Tablets, aimed at treating Prader-Willi Syndrome. The FDA has decided not to convene an advisory committee (AdCom) for the drug, which is seen as a positive indicator for its potential approval. This decision has led to a significant increase in Soleno's stock price, with shares rising 12% to a new 52-week high, and 7.9% in pre-market trading. The drug has also received Priority Review status from the FDA, further boosting investor confidence. Analysts suggest that the lack of an AdCom reduces potential uncertainties and highlights the FDA's recognition of the unmet medical need for treating Prader-Willi Syndrome. Additionally, Soleno benefits from low cash burn, which could support further stock gains.