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What will be the outcome of Soleno's DCCR tablets FDA review by March 31, 2025?
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FDA's official announcement on their website or press releases
Story
Soleno Therapeutics' Prader-Willi Drug Gets Positive FDA Update, Stock Soars 12% to 52-Week High
Oct 8, 2024, 06:14 PM
Soleno Therapeutics has announced a regulatory update on its DCCR (diazoxide choline) extended-release tablets designed to treat Prader-Willi Syndrome. The FDA has decided not to require an advisory committee meeting for the drug, which is seen as a positive indication of the drug's potential approval. This decision has led to a 12% increase in Soleno's stock price, reaching a new 52-week high, with a 7.9% pre-market rise. The company has also received Priority Review for the drug candidate, further boosting investor confidence. Soleno's low cash burn and the potential for a short squeeze are additional factors contributing to the stock's rise. The FDA's decision highlights the unmet need for treatments addressing PWS-associated hyperphagia.
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