REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ:SLNO) announced today that the U.S. Food and Drug Administration (FDA) has extended its review period for the company's New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets. This medication is intended for the treatment of Prader-Willi syndrome (PWS) in individuals aged four years and older who experience hyperphagia, a condition characterized by persistent, intense hunger.
The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of March 27, 2025. The extension follows the FDA's determination that recent responses to their information requests represent a major amendment to the NDA, warranting an additional three months to complete their review. The FDA has not raised any issues related to the safety, efficacy, or manufacturing processes of the drug in their correspondence.
Soleno submitted the NDA on June 27, 2024, which the FDA accepted and granted Priority Review status in August 2024. DCCR has also received Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation in both the U.S. and E.U.
PWS, a rare genetic disorder estimated to affect one in every 15,000 live births, leads to a variety of symptoms including hyperphagia, which can significantly impact the quality of life and may lead to life-threatening conditions and long-term health problems such as diabetes and heart disease. Currently, there are no approved treatments specifically targeting the hyperphagia and related symptoms of PWS.
DCCR, a once-daily oral tablet, has shown promise in addressing not only hyperphagia but also other symptoms of PWS, including aggressive behaviors and metabolic parameters, as indicated by data from its clinical development program.
Soleno Therapeutics focuses on developing and commercializing novel treatments for rare diseases. The extension of the review period by the FDA allows for a thorough evaluation of the additional information provided by Soleno. This announcement is based on a press release statement from Soleno Therapeutics.
In other recent news, Soleno Therapeutics has been receiving positive responses from various analyst firms like Oppenheimer, Laidlaw, Baird, and Stifel. These firms have maintained their positive outlooks on Soleno, highlighting the potential for significant revenues if the FDA approves DCCR, a treatment for Prader-Willi syndrome. The FDA's decision is expected in the near future, marking a significant milestone for Soleno Therapeutics.
Oppenheimer recently raised its price target for Soleno from $65.00 to $73.00, maintaining an Outperform rating. This revision is based on Soleno's updated sales projections which predict a significant growth in U.S. sales from 2025 to 2029. The firm cites an expected rise in diagnosis rates and the anticipated pricing strategy for DCCR as key factors for this revision.
In addition to these developments, Soleno has also seen changes in its Board of Directors with the appointment of Matthew Pauls as the new Lead Independent (LON:IOG) Director and the addition of Dawn Carter Bir to the board. The company has also entered into an agreement with Jefferies LLC to potentially sell up to $150 million of its common stock and has awarded performance-based restricted stock units to its employees. These are recent developments that have been shaping the trajectory of Soleno Therapeutics.
InvestingPro Insights
As Soleno Therapeutics (NASDAQ:SLNO) navigates the extended FDA review period for its DCCR treatment, investors may find valuable insights from recent financial data and market performance. According to InvestingPro, Soleno's stock has shown remarkable strength, with a significant 98.2% price return over the past year and a 39.02% return in the last six months. This positive momentum aligns with the company's progress in its drug development pipeline.
InvestingPro Tips highlight that Soleno's net income is expected to grow this year, and analysts predict the company will be profitable. This outlook is particularly relevant given the potential market impact of DCCR if approved for Prader-Willi syndrome treatment. Additionally, the company's strong liquidity position, with liquid assets exceeding short-term obligations, suggests financial stability as it awaits the FDA's decision.
However, investors should note that Soleno is currently trading at a high Price / Book multiple of 9.32, indicating market optimism about its future prospects. The company's market capitalization stands at $2.47 billion, reflecting significant investor interest in its potential breakthrough treatment.
For those seeking a deeper understanding of Soleno's financial health and market position, InvestingPro offers 14 additional tips, providing a comprehensive analysis to inform investment decisions in this promising biotech company.
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