Soleno Therapeutics launches VYKAT XR for rare disease

Published 07/05/2025, 21:12
Soleno Therapeutics launches VYKAT XR for rare disease

REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company with a market capitalization of $3.7 billion, has announced the U.S. launch of VYKAT XR, a treatment for hyperphagia associated with Prader-Willi syndrome (PWS), following its FDA approval on March 26, 2025. The company reported that as of May 6, 2025, it has received 268 patient start forms and 131 unique prescribers have administered the treatment since its market introduction on April 14th, 2025. The stock has shown remarkable strength, gaining nearly 64% year-to-date according to InvestingPro data.

The company’s financial results for the first quarter ending March 31, 2025, indicated a cash usage of $32.8 million in operating activities. Soleno held $290.0 million in cash, cash equivalents, and marketable securities at the end of the quarter, maintaining a strong current ratio of 15.7x and operating with a moderate debt-to-equity ratio of 0.22. Notably, there was no revenue during this period as commercialization of VYKAT XR began after the quarter ended.

Research and development expenses amounted to $13.5 million, which includes $4.3 million of non-cash stock-based compensation. This is a slight decrease from the $14.6 million spent in the same period in 2024. The company also incurred $0.7 million related to its upcoming Marketing Authorization Application submission to the European Medicines Agency (EMA), expected in the second quarter of 2025.

Selling, general, and administrative expenses were significantly higher at $29.3 million, with $10.4 million in non-cash stock-based compensation, reflecting the company’s preparation for the commercial launch of VYKAT XR.

The company noted an increase in the fair value of contingent consideration payable to former Essentialis stockholders, related to commercial milestones for VYKAT XR, which was estimated at $17.8 million as of March 31, 2025.

Soleno reported a net loss of approximately $43.8 million, or $0.95 per share, for the first quarter of 2025, compared to a net loss of $21.4 million, or $0.59 per share, for the same period in 2024.

The company’s management will host a conference call and webcast to discuss these financial and operational results and provide an update on the launch of VYKAT XR. According to InvestingPro analysis, analysts maintain a strong buy consensus with price targets ranging from $81 to $145 per share. Get access to 12 additional exclusive ProTips and comprehensive financial analysis with an InvestingPro subscription.

Soleno’s focus is on the development and commercialization of novel therapeutics for rare diseases. VYKAT XR, known as DCCR before its commercial name was adopted, is the company’s first commercial product and represents a significant milestone as a first-to-market treatment for hyperphagia in PWS patients. Based on InvestingPro’s Fair Value analysis, the stock appears to be trading near its fair value, with analysts expecting the company to become profitable this year. Discover detailed valuation metrics and growth potential in the comprehensive Pro Research Report, available for over 1,400 US stocks.

This article is based on a press release statement from Soleno Therapeutics.

In other recent news, Soleno Therapeutics has announced the U.S. commercial launch of VYKAT XR, an FDA-approved treatment for hyperphagia in individuals with Prader-Willi Syndrome (PWS). The drug, which has gained significant attention, is the first approved treatment specifically targeting hyperphagia associated with PWS. Piper Sandler recently raised its price target for Soleno Therapeutics to $145, citing the approval and anticipated successful launch of VYKAT XR. The firm maintains an Overweight rating on the stock, highlighting strong investor interest and the drug’s potential in an untapped market. Additionally, H.C. Wainwright increased its price target for the company to $100, up from $70, while maintaining a Buy rating, reflecting the positive market opportunity for VYKAT XR. In corporate governance news, Soleno Therapeutics appointed CBIZ CPAs as its new auditor, following the resignation of Marcum LLP. This change comes after Marcum expressed an adverse opinion on Soleno’s internal control over financial reporting for the year ending December 31, 2024. These developments indicate a period of significant activity for Soleno Therapeutics as it navigates its product launch and corporate changes.

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