Soleno Therapeutics Receives Breakthrough Therapy Designation from U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome (PWS)
Soleno Therapeutics, Inc. (SLNO)
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Source: GlobeNewswire
First Ever Breakthrough Designation for a Drug Being Developed for PWS Designation is Based on Data from the Phase 3 Program for DCCR Planned Submission of a New Drug Application (NDA) for DCCR Remains on Track for Mid-2024 REDWOOD CITY, Calif., April 29, 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 granted Breakthrough Therapy Designation to diazoxide choline for the treatment of adults and children ages 4 years and older with genetically confirmed Prader-Willi syndrome (PWS) who have hyperphagia. The designation reflects the Agency’s determination that, based on an assessment of the preliminary data from the Phase 3 clinical development program, diazoxide choline may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
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News
- Soleno Therapeutics Stands with the Prader-Willi Syndrome Community [Yahoo! Finance]Yahoo! Finance
- Soleno Therapeutics Stands with the Prader-Willi Syndrome CommunityGlobeNewswire
- Soleno Therapeutics, Inc. (NASDAQ: SLNO) was upgraded by analysts at Baird R W to a "strong-buy" rating.MarketBeat
- Soleno Therapeutics, Inc. (NASDAQ: SLNO) had its price target lowered by analysts at Oppenheimer Holdings Inc. from $65.00 to $59.00. They now have an "outperform" rating on the stock.MarketBeat
- INVESTIGATION ALERT: Kaskela Law LLC Announces Shareholder Investigation of Soleno Therapeutics, Inc. (SLNO) and Encourages Investors to Contact the FirmAccesswire
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- 5/9/24 - Miss
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Sec Filings
- 5/10/24 - Form 8-K
- 5/9/24 - Form 10-Q
- 5/7/24 - Form 8-K
- SLNO's page on the SEC website