Soleno stock maintains Overweight rating at Piper Sandler on VYKAT XR outlook

Piper Sandler reiterated its Overweight rating and $145 price target on Soleno Therapeutics (SLNO) after discussions with a European specialist who indicated strong willingness to prescribe VYKAT XR for Prader-Willi syndrome (PWS) upon potential EMA approval, expected around Q1 2026. Soleno anticipates filing its Marketing Authorization Application (MAA) in Q2 2025. The positive outlook is further supported by recent clinical data showing improvements in hyperphagia and behavioral symptoms, along with EMA validation of the MAA for Diazoxide Choline Prolonged-Release Tablets.

Analysis

Piper Sandler has reiterated its Overweight rating and a $145.00 price target for Soleno Therapeutics (NASDAQ:SLNO), which currently trades at $78.15 with a $3.94 billion market capitalization, indicating substantial perceived upside. This bullish stance is reinforced by discussions with a European pediatric endocrinologist, who manages 35-40 Prader-Willi syndrome (PWS) patients and expressed intent to prescribe VYKAT XR to nearly all eligible individuals upon its potential European approval. Soleno plans to file a Marketing Authorization Application (MAA) for VYKAT XR in the second quarter of 2025, with European Medicines Agency (EMA) approval and launch anticipated around the first quarter of 2026. VYKAT XR is positioned as a potentially first-in-class PWS treatment, addressing significant unmet medical needs, with other PWS therapies in development considered either too early-stage or having different mechanisms, suggesting potential for synergistic use. Supporting this outlook, VYKAT XR has already received FDA approval in the U.S. for patients aged four and older and is available for prescription. Recent positive clinical data highlighted improvements in hyperphagia and behavioral symptoms post-withdrawal, and Soleno's MAA for Diazoxide Choline Prolonged-Release Tablets has been validated by the EMA. This positive sentiment is shared by other firms, including Stifel (Buy rating, $108 target) and Cantor Fitzgerald (Overweight rating, $123 target), who point to encouraging U.S. launch dynamics and VYKAT XR's potential to become the standard of care. Soleno's stock has appreciated 84% over the past year, trading near its 52-week high of $81.54, reflecting investor confidence in its commercialization strategy and robust patent portfolio.

Key Decisions for Investors

• Investors should consider the significant valuation gap between Soleno's current share price and analyst targets, such as Piper Sandler's $145, alongside strong specialist endorsement for VYKAT XR, as indicative of substantial growth potential.
• Key upcoming catalysts to monitor include the European MAA filing for VYKAT XR in Q2 2025 and the subsequent EMA approval process targeted for Q1 2026, which could materially affect the company's valuation.
• Closely observe the U.S. commercialization progress of VYKAT XR, including prescription uptake rates, market access achievements, and payor interactions, as these will be critical indicators of its market penetration and revenue generation capabilities.