About Soleno:
Soleno Therapeutics Provides Update on U.S. Launch of VYKAT(TM) XR and Reports First Quarter 2025 Financial Results
May 7, 2025
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REDWOOD CITY, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update on the U.S. launch of VYKATTM XR and reported financial results for the first quarter ended March 31, 2025.
First Quarter 2025 and Recent Corporate Highlights
Announced U.S. Food and Drug Administration (FDA) approval of VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children four years of age and older with Prader-Willi syndrome (PWS).
Announced launch and commencement of patient treatments on April 14th, 2025.
From approval through May 6th, 2025 Soleno reports:
268 patient start forms received
131 unique prescribers of VYKAT XR
Continued to engage with leading payers regarding the value proposition of VYKAT XR with the goal of establishing broad access for patients.
Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) seeking marketing approval of DCCR (marketed in the U.S. as VYKAT XR) to patients with PWS in the E.U. on track for second quarter of 2025.
“During the first quarter of 2025, we achieved the most significant milestone in the history of our company with FDA approval of VYKAT XR for the treatment of hyperphagia in patients four years and older with Prader-Willi syndrome,” stated Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “While it has only been a few weeks since we announced approval and commercial availability, the high level of interest that we are experiencing, as reflected in both patient start forms and unique prescribers, reflects the significant unmet need that VYKAT XR can address as a first-to-market treatment for this debilitating condition. With a strong balance sheet and a world class team, I believe we are very well positioned to sustain our current momentum, delivering VYKAT XR to the patients who need it while creating significant long-term value for our company.”
Financial Results
Soleno’s efforts are primarily focused on executing a robust commercial launch of VYKAT XR following FDA approval on March 26th, 2025.
First Quarter Ended March 31, 2025 Financial Results
Soleno used $32.8 million of cash in its operating activities during the three months ended March 31, 2025, and had $290.0 million of cash, cash equivalents and marketable securities as of the end of the quarter.
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