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Investing.com -- Soleno Therapeutics (NASDAQ:SLNO) Inc. shares saw a significant surge in US premarket trading, rising by as much as 39% following the announcement of US Food and Drug Administration (FDA) approval for its Vykat extended-release tablets.
The medication is targeted at treating hyperphagia associated with Prader-Willi syndrome. Analysts have highlighted the FDA approval as a major catalyst for the stock, expressing positivity towards the clean label and pricing of Vykat.
Brian Skorney, an analyst at Baird, referred to the approval as a "key catalyst," suggesting it could lead to a significant upward re-rating of Soleno’s valuation. Baird has subsequently upgraded its price target for Soleno to $102, marking a boost in confidence for the biotech company’s prospects.
Furthermore, the commercial upside potential of Vykat is seen as very attractive, either as a standalone business or integrated into a larger infrastructure. This is due to its clean label and favorable interactions with payers. The FDA approval is a significant milestone for Soleno, boosting its market position and setting the stage for potential growth in its business.
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