Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA 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
PDUFA target action date set for December 27, 2024 FDA currently plans to hold an Advisory Committee meeting REDWOOD CITY, Calif., Aug. 27, 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 accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. The FDA granted Priority Review for the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024. Priority review is designated to applications for drugs that, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. In its Priority Review Designation letter, the FDA also stated that it is cur
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News
- Soleno Therapeutics Announces Oral Presentations featuring Diazoxide Choline Extended-Release (DCCR) Tablets in Prader-Willi Syndrome at ESPE 2024GlobeNewswire
- Here's Why We're Not At All Concerned With Soleno Therapeutics' (NASDAQ:SLNO) Cash Burn Situation [Yahoo! Finance]Yahoo! Finance
- 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 Provides Corporate Update and Reports Third Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial ResultsGlobeNewswire
SLNO
Earnings
- 11/6/24 - Miss
SLNO
Sec Filings
- 11/19/24 - Form SC
- 11/14/24 - Form SCHEDULE
- 11/14/24 - Form SC
- SLNO's page on the SEC website