Official press releases from Soleno Therapeutics

Soleno Therapeutics' Prader-Willi Syndrome Drug Sees Positive Regulatory Update, Stock Soars 12% to 52-Week High

Oct 8, 2024, 03:17 PM

Soleno Therapeutics has announced a regulatory update on its DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi Syndrome. The FDA has decided not to require an advisory committee meeting, indicating a strong outlook for the drug's approval. The news has led to a significant increase in Soleno's stock price, which rose 12% to a new 52-week high and 7.9% pre-market. The company has also received Priority Review for the drug candidate, further boosting investor confidence. Cantor noted that the FDA's decision supports the strength of the data around DCCR and the unmet need for PWS-associated hyperphagia.