Gold prices slip lower; consolidating after recent gains
Piper Sandler has reiterated an Overweight rating and $145.00 price target on Soleno Therapeutics Inc. (NASDAQ:SLNO), currently trading at $78.15 with a market cap of $3.94 billion. The firm’s bullish stance aligns with the broader analyst consensus, as revealed by InvestingPro data, following discussions with a European specialist about the company’s VYKAT XR medication for Prader-Willi syndrome (PWS).
Soleno expects to file a Marketing Authorization Application (MAA) for VYKAT XR in the second quarter of 2025, with potential European Medicines Agency (EMA) approval and subsequent launch anticipated around the first quarter of 2026, according to the research firm. The stock has shown remarkable strength, gaining 84% over the past year and currently trading near its 52-week high of $81.54.
The UK-based pediatric endocrinologist consulted by Piper Sandler manages approximately 35-40 PWS patients, with roughly 67-75% of them aged 4 years or older and 70% experiencing hyperphagia, a key symptom of PWS characterized by excessive hunger. The specialist indicated she would prescribe VYKAT XR to nearly all eligible patients upon potential approval.
The physician noted growing awareness of VYKAT XR and suggested that other PWS treatments in development are either too early-stage or have different mechanisms of action, potentially allowing for synergistic use with VYKAT XR rather than direct competition.
Piper Sandler emphasized that VYKAT XR represents significant potential as the first approved treatment specifically addressing PWS, a condition with substantial unmet medical needs.
In other recent news, Soleno Therapeutics has been actively advancing its product VYKAT XR, with significant developments in its treatment for Prader-Willi Syndrome (PWS). The company reported positive clinical data at the Pediatric Endocrine Society Annual Meeting, showing improvements in hyperphagia and behavioral symptoms for patients resuming VYKAT XR after a 16-week withdrawal. Additionally, Soleno’s Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets has been validated by the European Medicines Agency, marking a crucial step towards making the treatment available in the EU.
Analyst firms have shown strong confidence in Soleno’s potential. Stifel maintained a Buy rating with a $108 price target, citing encouraging initial launch dynamics for VYKAT and positive interactions with payors. Cantor Fitzgerald reaffirmed an Overweight rating with a $123 target, highlighting the treatment’s potential for attracting and retaining patients. Piper Sandler also reiterated an Overweight rating with a $145 target, emphasizing the significant market opportunity and VYKAT XR’s potential to become the standard of care for PWS patients.
The company has received FDA approval for VYKAT XR, now available for prescription in the U.S. for patients aged four and above. Soleno’s focus on market access and commercialization strategy, along with its strong patent portfolio, positions it well in the competitive landscape. The company’s management continues to express optimism about expanding VYKAT XR’s reach and solidifying its market position.
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