Soleno Therapeutics, Inc. (SLNO) Tuesday announced that the FDA has extended the review period for the New Drug Application for DCCR tablets targeted at patients with Prader-Willi syndrome. DCCR is a proprietary extended-release dosage form containing diazoxide choline, the crystalline salt of diazoxide and is expected to treat individuals of four years and older who have hyperphagia.
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The extension will allow FDA to complete their review, including that of the recently submitted information. The FDA did not cite any safety, efficacy or manufacturing concerns
The new Prescription Drug User Fee Act target action date will be March 27, 2025.
Diazoxide choline has been granted Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation in the U.S. and E.U. for the treatment of patients with Prader-Willi syndrome.
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