FDA Approves VYKAT XR for Prader-Willi Syndrome Treatment

FDA approval for Soleno Therapeutics' VYKAT XR brings encouraging news. Soleno Therapeutics anticipates availability by April 2025, promising a new treatment for hyperphagia in Prader-Willi syndrome.

Date: 27-03-2025

AI Rating: 7

Key Approval Announced

Soleno Therapeutics Inc. (SLNO) has received FDA approval for its drug VYKAT XR, aimed at treating hyperphagia in individuals with Prader-Willi syndrome. This approval is a significant milestone for the company and enhances its product portfolio.

The expected launch of VYKAT XR in April 2025 positions Soleno well within the therapeutic market for this syndrome, potentially increasing revenue streams.

This announcement does not provide any detailed financial metrics such as Earnings Per Share (EPS), Revenue Growth, Net Income, Profit Margins, Free Cash Flow (FCF), or Return on Equity (ROE). However, the approval may result in future positive financial indicators as the drug enters the market.

The 16-week randomized withdrawal study referenced confirms VYKAT XR's efficacy compared to placebo, which may encourage investor confidence in its commercial viability.

Stocks: SLNO