Welcome to our dedicated page for Soleno Therapeutics news (Ticker: SLNO), a resource for investors and traders seeking the latest updates and insights on Soleno Therapeutics stock.
Soleno Therapeutics, Inc. (symbol: SLNO) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics for the treatment of rare diseases. The company's lead candidate, DCCR (Diazoxide Choline Controlled-Release) Tablets, is a once-daily oral medication currently in its Phase 3 clinical development program for Prader-Willi Syndrome (PWS). PWS is a rare genetic disorder characterized by chronic hunger, leading to severe obesity, among other complications.
Soleno Therapeutics has achieved significant milestones, including the FDA's Breakthrough Therapy Designation for DCCR, indicating promising preliminary data. This designation aims to expedite the development and review process of DCCR, reflecting the drug's potential to offer substantial improvements over existing therapies.
Financially, Soleno is well-positioned, with cash and cash equivalents amounting to approximately $169.7 million as of December 31, 2023, bolstered by a successful public offering and warrant exercises. The company continues to invest significantly in research and development, with expenses reaching $25.2 million for the year ended December 31, 2023, primarily driven by clinical trial costs and manufacturing efforts in preparation for NDA submission.
Soleno's strategic partnerships and acquisitions, including the 2016 merger with Essentialis, have enhanced its pipeline and development capabilities. The company is obligated to pay up to $21.2 million to former Essentialis stockholders upon achieving specific commercial milestones for DCCR sales.
The clinical data supporting DCCR is robust, with extensive research from five Phase 1 studies in healthy volunteers and three Phase 2 studies, including one focused on PWS patients. The data suggests DCCR's potential in addressing hyperphagia, aggressive behaviors, and other metabolic parameters associated with PWS.
With a strengthened leadership team and a clear focus on advancing DCCR through regulatory processes, Soleno Therapeutics aims to provide a new treatment option for PWS patients. For the latest updates and more detailed information, visit the company's official website at www.soleno.life.
Soleno Therapeutics, Inc. announced a public offering of 3,000,000 shares of common stock at $46.00 per share, expected to yield approximately $138.0 million in gross proceeds. The company granted the underwriters a 30-day option to purchase up to 450,000 additional shares. The offering is set to close around May 7, 2024, with plans to utilize the proceeds for research and development of DCCR tablets for Prader-Willi Syndrome treatment, and general corporate purposes.
Soleno Therapeutics, a clinical-stage biopharmaceutical company, announced a proposed public offering of common stock. The company intends to offer shares to fund research and development efforts, including advancing DCCR tablets for the treatment of Prader-Willi Syndrome. The offering is subject to market conditions, with the net proceeds to be used for various corporate purposes.
Soleno Therapeutics announced the publication of a comparison study showing significant improvements in hyperphagia and PWS-related behaviors with DCCR treatment for Prader-Willi syndrome. The study demonstrated positive results from the Phase 3 trials, indicating the potential of DCCR to enhance the quality of life for PWS patients.
Soleno Therapeutics has received Breakthrough Therapy Designation from the U.S. FDA for DCCR in Prader-Willi Syndrome (PWS), marking the first ever for a drug developed for PWS. The designation is based on Phase 3 data, with plans for an NDA submission in mid-2024.
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