REDWOOD CITY, Calif. – Soleno Therapeutics, Inc. (NASDAQ: NASDAQ:SLNO), a biopharmaceutical company focused on developing treatments for rare diseases, has announced the U.S. Food and Drug Administration (FDA) acceptance of its New Drug Application (NDA) for DCCR tablets intended for Prader-Willi syndrome (PWS). The FDA has granted the application Priority Review status, with a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024.
PWS is a rare genetic disorder characterized by chronic hunger, known as hyperphagia, which can lead to life-threatening obesity and its related conditions. Currently, no approved treatments specifically address the hyperphagia and associated symptoms of PWS.
The Priority Review designation by the FDA is reserved for drugs that could offer significant improvements in the safety or effectiveness of treating serious conditions. This expedited review shortens the FDA's decision timeline with the goal of getting promising new therapies to patients sooner.
DCCR, or diazoxide choline extended-release tablets, is a once-daily oral medication. Its parent molecule, diazoxide, has been in use for other rare diseases but is not currently approved for PWS. Soleno's NDA submission is supported by data from multiple clinical studies, including a Phase 3 program that indicated DCCR's potential in managing not only hyperphagia but also aggressive behaviors, body fat, and other metabolic parameters in PWS patients.
According to the Prader-Willi Syndrome Association USA, PWS affects approximately one in every 15,000 births. The disorder's impact on patients and their families is profound, often involving cognitive disabilities, behavioral issues, and physical complications.
The company also noted the FDA's intention to convene an advisory committee meeting to discuss the application further. Soleno's CEO, Anish Bhatnagar, M.D., expressed gratitude towards the PWS community for their support and emphasized the company's commitment to working with the FDA throughout the review process.
Soleno Therapeutics has previously secured Breakthrough and Fast Track Designations for diazoxide choline in the U.S., as well as Orphan Drug Designation for PWS in both the U.S. and E.U.
This announcement is based on a press release statement from Soleno Therapeutics. As the review process continues, the PWS community and investors are watching closely, with the advisory committee meeting and the PDUFA target action date marking the next major milestones in the potential approval of DCCR.
In other recent news, Soleno Therapeutics has been making significant strides in its operations. The company has submitted a New Drug Application (NDA) to the FDA for its product DCCR, a treatment for Prader-Willi syndrome. Piper Sandler maintains a positive outlook on Soleno, citing the treatment's comprehensive benefits, its clean safety profile, and the undeniable unmet need recognized by the FDA.
In addition, Soleno Therapeutics has seen significant changes in its Board of Directors, with Matthew Pauls stepping in as the new Lead Independent Director and biotech veteran Dawn Carter Bir joining the board. The company has also entered an agreement with Jefferies LLC to potentially sell up to $150 million of its common stock, aiming to bolster its financial flexibility.
Furthermore, Soleno Therapeutics has awarded performance-based restricted stock units to its employees, including top executives, under the Amended and Restated 2014 Equity Incentive Plan. This move is part of a strategy to align employee interests with the company's performance. Lastly, the company has expanded its corporate footprint by securing a new office lease in Redwood (NYSE:RWT) City, California. These are the recent developments in the company's ongoing operational and strategic initiatives.
InvestingPro Insights
As Soleno Therapeutics, Inc. (NASDAQ: SLNO) garners attention with its recent FDA Priority Review status for DCCR tablets, investors are closely monitoring the company's financial health and stock performance. An InvestingPro Tip indicates that Soleno holds more cash than debt on its balance sheet, which may provide financial stability as they navigate the approval process. Additionally, analysts predict the company will be profitable this year, a potential turning point for a firm that has not been profitable over the last twelve months.
InvestingPro Data further reveals that Soleno Therapeutics has a market capitalization of approximately 1790M USD, reflecting the company's current valuation in the market. Despite the challenges, the stock has experienced a remarkable return of 815.28% over the last year, showcasing significant investor confidence. However, the stock is trading at a high Price / Book multiple of 6.39, suggesting it may be valued richly compared to its book value.
For those considering an investment in Soleno Therapeutics, it's worth noting that there are 11 additional InvestingPro Tips available on InvestingPro, offering deeper insights into the company's financials and market performance.
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