REDWOOD CITY, Calif. - Soleno Therapeutics, Inc. (NASDAQ: NASDAQ:SLNO), a biopharmaceutical company focused on rare diseases, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product DCCR (diazoxide choline) extended-release tablets. The treatment is intended for individuals aged four and older with Prader-Willi syndrome (PWS) who experience hyperphagia, a condition characterized by an insatiable hunger.
The company's CEO, Anish Bhatnagar, M.D., expressed the significance of this milestone for both Soleno and the PWS community, acknowledging the collaborative efforts that brought the development program to this stage.
The submission of the NDA for DCCR, which has been granted Breakthrough and Fast Track Designations by the FDA, as well as Orphan Drug Designation in both the U.S. and E.U., could potentially address the life-threatening hyperphagia and other critical aspects of PWS.
The FDA has a 60-day period to decide whether to accept the NDA for review. Soleno has requested Priority Review, which, if granted, would shorten the FDA's target review period to six months post-acceptance.
PWS is estimated to occur in one out of every 15,000 live births, and is associated with a range of symptoms including behavioral problems, cognitive disabilities, and metabolic issues alongside hyperphagia. Currently, there are no approved therapies specifically targeting the hyperphagia and related symptoms of this disorder.
DCCR is a once-daily oral tablet that has shown promise in addressing not only hyperphagia but also aggressive behaviors, body fat accumulation, and other metabolic parameters in PWS. The submission is supported by data from multiple Phase 1 and Phase 2 clinical studies, as well as a Phase 3 clinical development program.
The information in this article is based on a press release statement from Soleno Therapeutics. The forward-looking statements included in the press release are subject to risks and uncertainties, and there is no assurance that the FDA will accept the NDA for review or ultimately approve the drug for the treatment of PWS.
In other recent news, Soleno Therapeutics has been actively expanding its corporate footprint with a new office lease in Redwood (NYSE:RWT) City, California. The medical device company has also been vigorously engaging with investors, discussing the development and regulatory path of its drug candidate, DCCR.
Analysts from Piper Sandler, Oppenheimer, and Baird have all provided their ratings and price targets for the company, reflecting varying degrees of optimism about DCCR's market potential.
Piper Sandler maintained its Overweight rating on Soleno Therapeutics, with a consistent price target of $93.00. The firm highlighted the potential of DCCR to be expanded into other indications, enhancing its market position.
Meanwhile, Oppenheimer lowered its price target for Soleno but maintained an Outperform rating, emphasizing the high investor interest in DCCR's market potential. Baird initiated coverage on Soleno Therapeutics with an Outperform rating and a stock price target of $72.00, suggesting that the market valuation does not fully account for the potential of DCCR.
In addition to these developments, Soleno Therapeutics announced plans for a public offering of its common stock at $46 each, aiming to raise approximately $138 million. The proceeds from the sale are intended to support the company's research and development, particularly for the advancement of DCCR. These recent developments underscore Soleno Therapeutics' ongoing efforts to bring innovative treatments to patients with rare diseases.
InvestingPro Insights
As Soleno Therapeutics, Inc. (NASDAQ: SLNO) strives to make a significant impact on the Prader-Willi syndrome (PWS) community with its New Drug Application, the company's financial health and market performance offer additional insights. According to InvestingPro data, Soleno has a market capitalization of $1.52 billion, reflecting investor confidence in its potential growth.
Despite the challenges faced in the biopharmaceutical sector, Soleno's commitment to addressing rare diseases like PWS is mirrored in its stock price, which has seen a tremendous 859.77% return over the past year.
InvestingPro Tips suggest that Soleno holds more cash than debt on its balance sheet, providing a level of financial stability as it navigates the FDA approval process. Moreover, analysts predict that the company will be profitable this year, which could be a pivotal turn for a firm that has not been profitable over the last twelve months.
While the company's Price / Book ratio stands at a high 10.6, indicating a premium market valuation, Soleno's liquid assets exceed its short-term obligations, suggesting a robust liquidity position. For investors looking to delve deeper into Soleno's financial metrics and future prospects, InvestingPro offers additional tips.
Using the special coupon code PRONEWS24, investors can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription, granting them access to comprehensive analysis and insights that could inform investment decisions. There are 8 more InvestingPro Tips available for Soleno, providing a more detailed picture of the company's financial health and market potential.
Investors and stakeholders in the biopharmaceutical industry may find these insights particularly valuable as they assess Soleno's prospects amidst the NDA submission for its promising PWS treatment.
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