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Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2021 Financial Results
REDWOOD CITY, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., Nov. 10, 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 a corporate update, and reported financial results for the three and nine months ended September 30, 2021. “The recently announced top-line results from Soleno’s ongoing open-label extension study evaluating DCCR for the treatment of Prader-Willi syndrome (PWS), and the comparison of these data to matched subjects from the PATH for PWS (PfPWS) natural history study, highlight the compelling potential of this promising therapy in addressing the myriad physical and behavioral challenges faced by PWS patients and families,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “We have submitted these collective results to the U.S. Food and Drug Administration (FDA) as part of an ongoing discussion with the agency regarding the clinical data necessary to support the submission of a New Drug Application (NDA) to market DCCR for the treatment of PWS. We remain firmly committed to obtaining regulatory approval for DCCR as a new treatment for people with PWS as quickly as possible.” Third Quarter 2021 and Recent Corporate Highlights Submitted to the FDA top-line results from the company’s ongoing open-label extension study, C602, evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with PWS and its comparison to data from the PfPWS, an ongoing study sponsored by the Foundation for Prader-Willi Research (FPWR) to advance the understanding of the natural history in individuals with PWS. A total of 115 subjects were enrolled into C602, the extension study in PWS patients who completed DESTINY PWS, an international, multi-center, randomized, double-blind, placebo-controlled study of DCCR. Key top-line results of Study C602 Hyperphagia: There was a progressive improvement in hyperphagia, the primary endpoint in the DESTINY PWS study, represented by a decrease in the HQ-CT total score, which was highly significant (p","length":2573,"tagName":"div"}]