How are energy investors positioned?
Investing.com -- Soleno Therapeutics, Inc. (NASDAQ:SLNO) shares gained 2.6% after the biopharmaceutical company provided an update on the U.S. launch of its newly approved drug VYKAT XR and reported first quarter 2025 financial results.
Soleno reported a first quarter loss of $0.95 per share, $0.06 worse than analyst estimates of a $0.89 loss. The company did not generate any revenue in the quarter as it had not yet commenced commercialization of VYKAT XR, which was approved by the FDA on March 26, 2025 for treating hyperphagia in Prader-Willi syndrome patients.
Since launching VYKAT XR on April 14, Soleno has received 268 patient start forms and 131 unique prescribers as of May 6. The company highlighted strong early interest, reflecting significant unmet need for the first approved treatment for this condition.
"While it has only been a few weeks since we announced approval and commercial availability, the high level of interest that we are experiencing reflects the significant unmet need that VYKAT XR can address as a first-to-market treatment for this debilitating condition," said Anish Bhatnagar, CEO of Soleno Therapeutics.
Research and development expenses were $13.5 million in Q1, down from $14.6 million YoY. Selling, general and administrative expenses rose to $29.3 million from $8.5 million YoY as the company prepared for commercial launch.
Soleno ended the quarter with $290 million in cash and marketable securities. The company plans to submit a Marketing Authorization Application to European regulators in Q2 2025 seeking approval for VYKAT XR in the EU.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.