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Soleno Therapeutics' Prader-Willi Drug Gains FDA Priority Review, Stock Rockets 12% to 52-Week High

Oct 8, 2024, 03:17 PM

Soleno Therapeutics has announced a regulatory update for its DCCR (diazoxide choline) extended-release tablets, which are designed to treat Prader-Willi Syndrome. The FDA has decided not to require an advisory committee meeting, indicating a strong outlook for the drug's approval. This regulatory development has led to a significant increase in Soleno's stock price, with shares rising by 12% to a new 52-week high. The company has also received Priority Review status for the drug, which further supports the positive sentiment around its potential approval. Cantor noted that the FDA's decision supports the strong data around DCCR. Soleno's stock had already risen by 7.9% pre-market. The company also benefits from low cash burn.