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Soleno Therapeutics Says FDA Accepts Application for Prader-Willi Syndrome Drug
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Soleno Therapeutics Says FDA Accepts Application for Prader-Willi Syndrome Drug
Aug 27, 2024 7:20 AM

08:41 AM EDT, 08/27/2024 (MT Newswires) -- Soleno Therapeutics ( SLNO ) said Tuesday that the US Food and Drug Administration has accepted a new drug application for its experimental drug, DCCR, to treat Prader-Willi syndrome in certain patients four years of age and older.

The company said the FDA granted priority review for the new drug application and expected a decision by December 27.

In its priority review designation letter, the FDA also stated it plans to hold an advisory committee meeting to discuss the application.

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