REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ: NASDAQ:SLNO), a biopharmaceutical company focused on developing treatments for rare diseases, has received a regulatory update from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets. The FDA's Review Division indicated that an advisory committee meeting may not be necessary at this stage for the evaluation of DCCR's use in treating Prader-Willi syndrome (PWS).
This development follows the FDA's previous decision to grant the DCCR NDA Priority Review status, with a target action date set for December 27, 2024. The FDA's Review Division, while currently not planning an advisory committee meeting, will still consider whether such a meeting will be needed as the review progresses.
Prader-Willi syndrome is a rare genetic disorder affecting one in every 15,000 live births. It is marked by chronic hunger, known as hyperphagia, which leads to excessive eating and life-threatening obesity-related complications. Currently, there are no approved treatments that address the hyperphagia and related metabolic, cognitive, and behavioral aspects of PWS.
DCCR, a once-daily oral tablet, represents a novel therapeutic approach for PWS. It has shown promise in Phase 3 clinical trials by potentially addressing hyperphagia and other symptoms, including aggressive behaviors and body fat composition. Despite its long-standing use in other rare diseases, diazoxide, the parent molecule of DCCR, has not been approved for PWS treatment.
Soleno Therapeutics has patented diazoxide choline and DCCR for PWS use and has completed several Phase 1 and 2 clinical studies, including trials involving individuals with PWS.
The company's forward-looking statements regarding the FDA review process and the potential approval of DCCR for PWS treatment are based on current expectations and involve risks and uncertainties. These statements reflect information available as of today and may change based on future developments.
This news article is based on a press release statement from Soleno Therapeutics.
In other recent news, Soleno Therapeutics has experienced significant developments. The U.S. Food and Drug Administration (FDA) has accepted Soleno's New Drug Application (NDA) for its diazoxide choline controlled-release (DCCR) treatment, a potential solution for Prader-Willi Syndrome. The application has received Priority Review status, targeting a decision by December 27, 2024. Stifel, maintaining a Buy rating on the stock, has raised the price target for Soleno Therapeutics to $74, citing potential approval of DCCR and the strength of its market exclusivity.
Piper Sandler reiterated its Overweight rating on Soleno Therapeutics, maintaining a price target of $93.00, based on the anticipated favorable outcome for DCCR. The firm expressed confidence in the drug's clear safety profile and the high unmet medical need within the patient population. Similarly, H.C. Wainwright initiated coverage with a Buy rating, anticipating a supportive outcome for DCCR approval and revenue generation from 2025.
Other noteworthy developments include changes in Soleno Therapeutics' Board of Directors, with Matthew Pauls becoming the new Lead Independent Director and Dawn Carter Bir joining the board. The company has also entered into an agreement with Jefferies LLC to potentially sell up to $150 million of its common stock. Additionally, Soleno Therapeutics has awarded performance-based restricted stock units to its employees, aligning their interests with the company's performance.
InvestingPro Insights
As Soleno Therapeutics (NASDAQ: SLNO) advances its New Drug Application for DCCR, investors are closely watching the company's financial health and market performance. According to InvestingPro data, Soleno's market capitalization stands at $1.85 billion, reflecting significant investor interest in the company's potential breakthrough in Prader-Willi syndrome treatment.
Despite not being profitable over the last twelve months, with an operating income of -$68.5 million, InvestingPro Tips suggest that Soleno's net income is expected to grow this year. This projection aligns with the company's progress in the FDA review process for DCCR, which could potentially lead to commercialization if approved.
Interestingly, Soleno's stock has shown remarkable performance, with a one-year price total return of 104.6% as of the latest data. This strong market sentiment is further supported by an InvestingPro Tip indicating that the company holds more cash than debt on its balance sheet, which could provide financial flexibility as it navigates the regulatory pathway.
For investors seeking a deeper understanding of Soleno's prospects, InvestingPro offers 7 additional tips that could provide valuable insights into the company's financial position and market dynamics. These tips, along with real-time metrics, can help in making more informed investment decisions as Soleno approaches its critical FDA target action date in December 2024.
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