Official announcements from Soleno Therapeutics or acquiring company

Soleno Therapeutics' Stock Soars 12% to 52-Week High as FDA Backs Prader-Willi Syndrome Drug

Oct 8, 2024, 03:17 PM

Soleno Therapeutics has announced a regulatory update on its DCCR (diazoxide choline) Extended-Release Tablets for the treatment of Prader-Willi Syndrome. The FDA has decided not to require an advisory committee meeting for the drug, indicating a strong outlook for its approval. This decision has positively impacted Soleno Therapeutics' stock, which has increased by 12% to a new 52-week high and by 7.9% pre-market. The company has also received Priority Review for its drug candidate, further supporting the potential for approval. The lack of an advisory committee meeting reduces potential uncertainty, and the market is optimistic about the drug's approval due to the strong data supporting its efficacy and the unmet need for treatments addressing PWS-associated hyperphagia.