Soleno Therapeutics Announces FDA Extension of Review Period for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome
Soleno Therapeutics, Inc. (SLNO)
Last soleno therapeutics, inc. earnings: 5/13 08:00 am
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Source: GlobeNewswire
REDWOOD CITY, Calif., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. The new Prescription Drug User Fee Act (PDUFA) target action date is March 27, 2025. The FDA determined that responses to recent information requests constituted a major amendment to the NDA, resulting in the extension of the PDUFA goal date by three months. The extension allows the FDA time to complete their review, including that of the recently submitted information. The FDA did not cite any safety, efficacy or manufacturing concerns in their correspondence. Soleno subm
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News
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- Soleno Therapeutics, Inc. (NASDAQ: SLNO) had its "buy" rating re-affirmed by analysts at Stifel Nicolaus. They now have a $74.00 price target on the stock.MarketBeat
- Soleno Therapeutics, Inc. (NASDAQ: SLNO) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $70.00 price target on the stock.MarketBeat
- Soleno Therapeutics, Inc. (NASDAQ: SLNO) had its "outperform" rating re-affirmed by analysts at Robert W. Baird. They now have a $72.00 price target on the stock.MarketBeat
SLNO
Earnings
- 11/6/24 - Miss
SLNO
Sec Filings
- 1/6/25 - Form 4
- 1/6/25 - Form 4
- 1/6/25 - Form 4
- SLNO's page on the SEC website