Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of 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., March 08, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended release tablets for the treatment of Prader-Willi Syndrome (PWS). Subsequent to the previously disclosed Type C meeting with the FDA on November 12, 2020 regarding the potential adequacy of data from studies with DCCR to support a New Drug Application (NDA) for the treatment of PWS, Soleno submitted additional analyses to the FDA from the Company’s Phase 3 trial, DESTINY PWS (C601). These data were from study visits that were completed prior to the significant disruptions caused by the COVID-19 pandemic. The data analyses showed statistically significant changes for DCCR compared to placebo
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News
- Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- How Hard Is It To Be A Biotech Venture Capitalist? [Forbes]Forbes
- We're Not Worried About Soleno Therapeutics' (NASDAQ:SLNO) Cash Burn [Yahoo! Finance]Yahoo! Finance
- Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results [Yahoo! Finance]Yahoo! Finance
SLNO
Sec Filings
- 4/22/24 - Form ARS
- 4/22/24 - Form DEF
- 4/22/24 - Form 8-K
- SLNO's page on the SEC website