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. (NASDAQ: SLNO) announced that CEO Anish Bhatnagar will participate in a fireside chat at the Guggenheim Healthcare Talks on April 3, 2023, at 10:10 AM Eastern Time. This event focuses on genomic medicines and rare diseases. Investors can access a live audio webcast as well as a replay of the discussion on the company's website. Soleno is actively developing innovative therapies for rare diseases, particularly its lead candidate, DCCR extended-release tablets, targeting Prader-Willi syndrome, which is in Phase 3 clinical trials.
Soleno Therapeutics (NASDAQ: SLNO) provided a corporate update and financial results for Q4 and full-year 2022. Enrollment in Study C602 for DCCR treatment of Prader-Willi syndrome is nearing completion, with top-line data expected by Q3 2023. The company secured a $60 million Securities Purchase Agreement with healthcare investors, with the first $10 million contingent upon the completion of enrollment. As of December 31, 2022, Soleno reported $14.6 million in cash. R&D expenses decreased to $15.3 million for the year, while net loss reduced to $24.1 million, or $2.87 per share. Strengthened funding enhances operational capability ahead of critical data announcements.
Soleno Therapeutics, Inc. (NASDAQ: SLNO), a clinical-stage biopharmaceutical company, has announced that CEO Anish Bhatnagar will participate in a fireside chat at Oppenheimer’s 33rd Annual Healthcare Conference on March 14, 2023, at 11:20 AM Eastern Time. This participation highlights Soleno's commitment to transparency and engagement with investors. The event will be accessible via a live audio webcast, available on the company’s website. Soleno specializes in developing novel therapeutics for rare diseases, with its lead candidate, DCCR, currently undergoing Phase 3 clinical trials for Prader-Willi syndrome.
Soleno Therapeutics (NASDAQ: SLNO) announced the publication of results from its Phase 3 DESTINY PWS trial for DCCR (Diazoxide Choline) Extended-Release tablets in treating Prader-Willi Syndrome (PWS) in the peer-reviewed Journal of Clinical Endocrinology and Metabolism. The promising trial outcomes have prompted the initiation of a randomized withdrawal phase in the ongoing extension study C602, potentially paving the way for a New Drug Application submission. PWS affects 1 in 15,000 births, marked by severe hunger and related health issues, underscoring the urgent need for effective treatments.
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