Business
Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2021 Financial Results
REDWOOD CITY, Calif., March 31, 2022 (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., March 31, 2022 (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 announced financial results for the fourth quarter and full-year ended December 31, 2021. Fourth Quarter 2021 and Recent Corporate Highlights Received official meeting minutes on January 20, 2022, from the December 21, 2021, Type C meeting with the U.S. Food and Drug Administration’s (FDA) Division of Psychiatry. The purpose of the meeting was to discuss the adequacy of the data submitted to the FDA by Soleno in October 2021 to support a potential New Drug Application (NDA) submission for diazoxide choline extended-release (DCCR) tablets for the treatment of Prader-Willi syndrome (PWS), as well as possible ways to generate additional controlled clinical data. Soleno recently submitted a study proposal involving participants currently enrolled in Study C602, Soleno’s ongoing open-label extension study, and intends to initiate the study after alignment with the FDA is reached.Announced that Running for Research - Prader-Willi Syndrome, an organization committed to raising private donations in support of advancing the science around PWS, will fund an investigator-sponsored clinical study to evaluate DCCR in patients with early phase PWSClosed $15 million public offering on March 31, 2022Participated in the BIO CEO & Investor Conference Participated in the LifeSci Partners 11th Annual Corporate Access Event “Following our recent discussions with the FDA, the Soleno team remains focused on advancing our late-stage DCCR program to an NDA submission,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Based on the feedback from the FDA, we recently submitted a study proposal to generate additional controlled clinical data involving patients currently enrolled in our ongoing open-label extension study, Study C602. Once alignment with the FDA is reached, we anticipate study initiation shortly thereafter. We remain confident in DCCR’s efficacy and safety based on the considerable data we have generated to date and look forward to continuing to work closely with the FDA, providers, patients and the entire PWS community to bring this important therapy to people wit...