Business
Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2022 Financial Results
REDWOOD CITY, Calif., Nov. 09, 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., Nov. 09, 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 reported financial results for the three and nine months ended September 30, 2022. Third Quarter 2022 and Recent Corporate Highlights Initiated the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS) U.S. Food and Drug Administration (FDA) previously acknowledged that data from the study has the potential to support a New Drug Application (NDA) submission for DCCRRandomized withdrawal period consists only of patients currently enrolled in Study C602 and will not enroll any new subjectsTop-line data expected in the first half of 2023 Exposure response analysis of DCCR in PWS was presented at the Foundation For Prader-Willi Research (FPWR) Research Symposium and Family Conference in September 2022 Analysis showed that long term hyperphagia change from baseline was significantly associated with circulating drug levels, with greater improvements associated with higher circulating drug levels Significant exposure response relationships were also characterized for leptin and insulin change from baseline and for various safety parameters evaluated “The initiation of the randomized withdrawal phase of Study C602 is an important step in advancing our late-stage DCCR program towards NDA submission,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “We anticipate top-line data in the first half of 2023, and are confident that these results, together with the robust data generated to date from our DCCR development program, will demonstrate the significant potential of this promising product candidate as an effective and safe therapy for patients with PWS who have limited therapeutic options.” Financial ResultsSoleno’s current research and development efforts are primarily focused on advancing its lead product candidate, DCCR, for the treatment of PWS, through late-stage clinical development. Cash at the end of September 30, 2022 was $19.8 million, which the Company believes is sufficient to fund operations at least through top line-data expec...