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REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biotechnology company with a market capitalization of $2.25 billion, announced the FDA approval of VYKAT XR for treating hyperphagia in individuals with Prader-Willi syndrome (PWS), a rare genetic disorder. According to InvestingPro analysis, the stock is currently trading above its Fair Value, though analysts maintain price targets ranging from $67 to $93. This medication, previously known as DCCR, is the first approved therapy specifically targeting hyperphagia, a condition characterized by an insatiable appetite leading to life-threatening obesity. VYKAT XR is expected to be available in the U.S. from April 2025.
The company’s CEO, Dr. Anish Bhatnagar, expressed gratitude towards participants, advocacy groups, and the FDA for their roles in this development. Dr. Jennifer Miller, a specialist in PWS and a principal investigator for VYKAT XR’s clinical program, highlighted the drug’s potential to significantly improve the quality of life for PWS individuals and their families. Stacy Ward, CEO of the Prader-Willi Syndrome Association | USA, and Susan Hedstrom, Executive Director of the Foundation for Prader-Willi Research, also acknowledged the approval as a pivotal advancement for the PWS community.
The FDA’s decision was based on a comprehensive clinical program, including a Phase 3 trial, which showed a significant worsening of hyperphagia in patients who were switched to a placebo compared to those who continued with VYKAT XR. Patients had been treated with the drug for an average of 3.3 years prior to the trial. InvestingPro data reveals the company maintains strong financial flexibility with a current ratio of 15.68, suggesting robust ability to fund ongoing commercialization efforts. The most common adverse reactions included hypertrichosis, edema, hyperglycemia, and rash.
To support patient access to VYKAT XR, Soleno launched Soleno One™, a comprehensive patient support program, and provided a toll-free number and a website for healthcare providers to initiate treatment access.
The announcement was followed by an investor conference call and webcast hosted by Soleno management to discuss the FDA approval details.
Prader-Willi syndrome affects approximately one in every 15,000 live births. The disorder leads to a variety of symptoms, with hyperphagia being the most life-limiting. VYKAT XR’s approval marks a significant milestone for the treatment of this aspect of PWS. InvestingPro analysis indicates strong market confidence in Soleno’s future, with analysts projecting profitability this year. The stock’s negative beta of -1.69 suggests it could provide portfolio diversification benefits, as it often moves counter to broader market trends. Get access to 8 more exclusive ProTips and comprehensive financial analysis with an InvestingPro subscription.
This article is based on a press release statement from Soleno Therapeutics.
In other recent news, Soleno Therapeutics is garnering attention as it approaches a significant milestone with the potential FDA approval of its drug DCCR for Prader-Willi Syndrome. Stifel analysts have reiterated their Buy rating with a price target of $74, citing optimism about DCCR’s approval prospects given the unmet need in the rare disease space. The Prescription Drug User Fee Act (PDUFA) date for DCCR is set for March 27th, and Stifel estimates an 80% probability of success for its approval. Cantor Fitzgerald also maintains an Overweight rating with a $67 price target, reflecting confidence in Soleno’s financial trajectory despite conservative revenue estimates for 2025.
Additionally, Soleno Therapeutics has announced changes to its executive compensation program, including salary increases and bonuses for its top executives. CEO Anish Bhatnagar’s new base salary is $739,000, with a cash bonus of $403,200 for fiscal year 2024. The company has also granted equity awards to its executives, aligning compensation with performance and market standards. These developments underscore Soleno’s strategic positioning as it prepares for a potential new drug launch. The anticipation surrounding DCCR’s approval and the company’s financial adjustments highlight Soleno Therapeutics’ ongoing efforts to enhance shareholder value.
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