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-0.0118736042876284 -0.0118736042876284 -0.0174184903974989 -0.000446627958910139 -0.00298794104510944 0.0384859312192943 0.114895042429656 0.164805716837874
Stock impact report

Soleno Therapeutics Receives Breakthrough Therapy Designation from U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome (PWS) [Yahoo! Finance]

Soleno Therapeutics, Inc. (SLNO) 
Last soleno therapeutics, inc. earnings: 5/13 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: investors.soleno.life/investor-overview
Company Research Source: Yahoo! Finance
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. “The granting of Breakthrough Therapy Designation, the first for a drug being developed for the treatment of PWS, marks another important m Show less Read more
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