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 (NASDAQ: SLNO) has secured a $200 million debt financing agreement with Oxford Finance The deal includes an initial draw of $50 million at closing, with an additional $100 million available in three tranches contingent on FDA approval of DCCR for Prader-Willi syndrome and commercial milestones. The remaining $50 million will be available upon mutual consent.
The loan features a 48-month interest-only period and 60-month total term, with possible 12-month extensions if specific milestones are met by September 2026. Interest accrues at 1-month term SOFR plus 5.50%. Following the initial draw, Soleno's pro-forma cash position stands at $334.7 million as of September 30, 2024.
Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease therapeutics, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's management will engage in a fireside chat on Thursday, December 5, 2024, at 9:00 AM Eastern Time. Interested parties can access both the live audio webcast and replay through the Investors section of Soleno's website at www.soleno.life.
Soleno Therapeutics announced that the FDA has extended the review period for DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi syndrome (PWS) in patients four years and older with hyperphagia. The new PDUFA target action date is pushed back by three months to March 27, 2025. The extension follows the FDA's determination that responses to recent information requests constituted a major amendment to the NDA. The FDA did not cite any safety, efficacy, or manufacturing concerns. The drug has received Breakthrough, Fast Track, and Orphan Drug Designations.
Soleno Therapeutics (NASDAQ: SLNO) announced two upcoming oral presentations at the 62nd Annual European Society for Paediatric Endocrinology Meeting 2024 in Liverpool, UK. The presentations will showcase data from their DCCR clinical development program for Prader-Willi syndrome (PWS) treatment. The first presentation focuses on food control parameters and hyperphagia reduction, while the second discusses long-term efficacy results from the DESTINY PWS and C602 studies. PWS affects one in 15,000 live births, with hyperphagia as its hallmark symptom, causing intense hunger and food-seeking behavior. Currently, there are no approved therapies for PWS's hyperphagia, metabolic, cognitive, or behavioral aspects.
Soleno Therapeutics (NASDAQ: SLNO) reported key developments in Q3 2024, including FDA acceptance of their New Drug Application for DCCR tablets treating Prader-Willi syndrome, with Priority Review and a PDUFA date of December 27, 2024. The company reported a net loss of $76.6 million ($1.83 per share) compared to $10.9 million in Q3 2023. R&D expenses were $30.1 million, while G&A expenses reached $49.2 million. The company maintains a strong balance sheet with $284.7 million in cash and equivalents, preparing for potential commercial launch.
Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease therapeutics, has announced its participation in three major healthcare investor conferences in November 2024. The company will present at the Guggenheim Healthcare Innovation Conference (Nov 11, 10:00 AM ET), Stifel 2024 Healthcare Conference (Nov 18, 4:45 PM ET), and Jefferies London Healthcare Conference (Nov 20, 8:00 AM GT). Live audio webcasts and replays will be available for the Guggenheim and Jefferies events through the company's website.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) has announced the passing of Ernest Mario, Ph.D., former Chairman of the Board of Directors, at the age of 86. Dr. Mario served as Soleno's Chairman from 2007 through August 2024. The company expressed deep sadness and extended condolences to Dr. Mario's family.
Dr. Mario had a distinguished career in the pharmaceutical industry spanning decades. He held key positions at companies such as Strasenburgh Laboratories, SmithKline, Squibb Corp., and Glaxo plc. As CEO and Deputy Chairman of Glaxo, he oversaw the launch of five major brands, leading the company to become the second-largest pharmaceutical company globally. He later served as CEO of Alza and Chairman and CEO of Reliant Pharmaceuticals.
Soleno Therapeutics acknowledged Dr. Mario's significant contributions to the development of new treatments for various diseases and his commitment to the company's success.
Soleno Therapeutics (NASDAQ: SLNO) has received a regulatory update from the FDA regarding its New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets to treat Prader-Willi syndrome (PWS). The FDA Review Division has determined that an advisory committee meeting does not appear necessary at this time. However, the review team will continue to consider this possibility during their ongoing evaluation.
The DCCR NDA has been designated for Priority Review with a PDUFA target action date of December 27, 2024. Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases.
Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease treatments, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will present on Tuesday, September 17, 2024, at 8:00 AM Eastern Time.
Investors and interested parties can access a live audio webcast of the presentation through Soleno's website. The presentation will also be available for replay in the Investors section at www.soleno.life. This conference provides Soleno with an opportunity to showcase its progress in developing novel therapeutics for rare diseases to a global audience of healthcare industry professionals and investors.
Soleno Therapeutics announced that the FDA has accepted for filing and granted Priority Review to its New Drug Application (NDA) for DCCR (Diazoxide Choline) Extended-Release Tablets for treating Prader-Willi syndrome (PWS) in individuals four years and older with hyperphagia. The PDUFA target action date is set for December 27, 2024. The FDA plans to hold an Advisory Committee meeting to discuss the application.
Priority Review is designated for drugs that could significantly improve treatment of serious conditions. DCCR has Breakthrough and Fast Track Designations in the U.S., and Orphan Drug Designation for PWS in both the U.S. and E.U. This acceptance marks a important milestone for Soleno and the PWS community, highlighting the potential impact of DCCR in addressing this rare and devastating condition.
FAQ
What is the current stock price of Soleno Therapeutics (SLNO)?
What is the market cap of Soleno Therapeutics (SLNO)?
What is Soleno Therapeutics' primary focus?
What is DCCR?
What recent milestones has Soleno Therapeutics achieved?
What is Prader-Willi Syndrome (PWS)?
What is the current financial status of Soleno Therapeutics?
What significant data supports the development of DCCR?
What are Soleno's obligations to former Essentialis stockholders?
What partnerships has Soleno Therapeutics formed?
What are the next steps for Soleno Therapeutics?
Where can I find more information about Soleno Therapeutics?
