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Soleno Therapeutics ( (SLNO) ) has shared an announcement.
On April 7, 2026, Soleno Therapeutics, Inc. announced that it had voluntarily withdrawn its marketing authorization application in Europe for VIOKAT prolonged-release tablets, known in the U.S. as VYKAT XR, for treating hyperphagia in adults and children aged four and older with Prader-Willi syndrome. The company said the move, based on business and strategic considerations, halts the ongoing European Medicines Agency review but preserves its option to return to European regulators in the future if a viable path emerges to advance the program.
The decision removes a near-term European regulatory catalyst for Soleno and may delay potential market expansion for its Prader-Willi syndrome therapy outside the U.S. However, by framing the withdrawal as strategic rather than clinical or safety-related, the company signals an intent to reassess timing, resources, and regulatory strategy, which could affect expectations among investors, patients, and partners about the pace of its international growth.
The most recent analyst rating on (SLNO) stock is a Buy with a $44.00 price target. To see the full list of analyst forecasts on Soleno Therapeutics stock, see the SLNO Stock Forecast page.
Spark’s Take on SLNO Stock
According to Spark, TipRanks’ AI Analyst, SLNO is a Neutral.
The score is driven primarily by the 2025 financial inflection to meaningful revenue, profitability and free cash flow, reinforced by strong earnings-call guidance and commercial KPIs plus a low-leverage balance sheet. Offsetting factors are weak longer-term technicals (below 100/200-day averages with negative MACD) and a stretched valuation (P/E ~117.9) that increases sensitivity to execution and regulatory/gross-to-net risks.
To see Spark’s full report on SLNO stock, click here.
More about Soleno Therapeutics
Soleno Therapeutics, Inc. is a biopharmaceutical company focused on developing therapeutics for rare diseases, with an emphasis on central nervous system and metabolic disorders. Its lead product, a prolonged-release formulation of diazoxide choline, is being developed to treat hyperphagia in adults and children with Prader-Willi syndrome, a rare genetic condition characterized by insatiable hunger.
Average Trading Volume: 2,622,531
Technical Sentiment Signal: Buy
Current Market Cap: $2.7B
Find detailed analytics on SLNO stock on TipRanks’ Stock Analysis page.