Latest news with #SolenoTherapeutics
Yahoo
24-05-2025
- Business
- Yahoo
Soleno Therapeutics, Inc. (SLNO) Secures EMA Validation for PWS Treatment VYKAT XR
Soleno Therapeutics, Inc. (NASDAQ:SLNO) has achieved a major regulatory milestone as the European Medicines Agency (EMA) validated its Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets (formerly DCCR) to treat hyperphagia in Prader-Willi syndrome (PWS) for patients aged four and older. This follows the recent U.S. FDA approval of the drug, now marketed as VYKAT XR, marking it as the first approved therapy specifically targeting hyperphagia, the most life-limiting symptom of PWS, in both adults and children. A researcher studying cellular therapeutics under a microscope. PWS is a rare genetic disorder characterized by insatiable hunger, leading to dangerous food-seeking behaviors and severe health complications. Soleno Therapeutics, Inc. (NASDAQ:SLNO) estimates that about 9,500 PWS patients in the UK, France, Germany, Italy, and Spain could benefit from this therapy if approved in Europe. The company has also secured Orphan Drug Designation in the EU, potentially granting up to 10 years of market exclusivity. Soleno Therapeutics, Inc. (NASDAQ:SLNO)'s CEO, Dr. Anish Bhatnagar, emphasized the importance of this milestone in expanding access to a much-needed treatment for the PWS community across Europe. The company is working closely with regulators to expedite the availability of the therapy, which has shown promise in addressing a critical unmet need for patients and families. SLNO surged by over 61% in 2025 so far. While we acknowledge the potential of SLNO to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SLNO and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
Soleno Therapeutics seeking regulatory approval in treatment of PWS
Soleno Therapeutics (SLNO) 'announced that Soleno's Marketing Authorization Application seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets for the treatment of adults and children four years and older with Prader-Willi syndrome who have hyperphagia had been validated by the European Medicines Agency.' 'The validation of our MAA represents the next significant milestone in our mission to deliver this important therapy to the broad PWS community, including those in the EU,' said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. 'Based on the data generated, DCCR has the potential to help treat hyperphagia, which is the most life-limiting aspect of PWS. We look forward to working closely with European regulators during the review process and intend to make DCCR available to patients in the EU as expeditiously as possible, if approved.' Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on SLNO: Disclaimer & DisclosureReport an Issue Soleno Therapeutics presents Vykat XR data at Pediatric Endocrine Society Soleno Therapeutics' Optimistic Earnings Call Highlights VYKAT XR Launch Soleno Therapeutics price target raised to $97 from $81 at Guggenheim Soleno Therapeutics price target raised to $105 from $102 at Baird Soleno Therapeutics Reports Q1 2025 Results and VYKAT XR Launch
Yahoo
23-05-2025
- Business
- Yahoo
Soleno Therapeutics, Inc. (SLNO) Secures EMA Validation for PWS Treatment VYKAT XR
Soleno Therapeutics, Inc. (NASDAQ:SLNO) has achieved a major regulatory milestone as the European Medicines Agency (EMA) validated its Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets (formerly DCCR) to treat hyperphagia in Prader-Willi syndrome (PWS) for patients aged four and older. This follows the recent U.S. FDA approval of the drug, now marketed as VYKAT XR, marking it as the first approved therapy specifically targeting hyperphagia, the most life-limiting symptom of PWS, in both adults and children. A researcher studying cellular therapeutics under a microscope. PWS is a rare genetic disorder characterized by insatiable hunger, leading to dangerous food-seeking behaviors and severe health complications. Soleno Therapeutics, Inc. (NASDAQ:SLNO) estimates that about 9,500 PWS patients in the UK, France, Germany, Italy, and Spain could benefit from this therapy if approved in Europe. The company has also secured Orphan Drug Designation in the EU, potentially granting up to 10 years of market exclusivity. Soleno Therapeutics, Inc. (NASDAQ:SLNO)'s CEO, Dr. Anish Bhatnagar, emphasized the importance of this milestone in expanding access to a much-needed treatment for the PWS community across Europe. The company is working closely with regulators to expedite the availability of the therapy, which has shown promise in addressing a critical unmet need for patients and families. SLNO surged by over 61% in 2025 so far. While we acknowledge the potential of SLNO to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SLNO and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
23-05-2025
- Health
- Business Insider
Soleno Therapeutics seeking regulatory approval in treatment of PWS
Soleno Therapeutics (SLNO) 'announced that Soleno's Marketing Authorization Application seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets for the treatment of adults and children four years and older with Prader-Willi syndrome who have hyperphagia had been validated by the European Medicines Agency.' 'The validation of our MAA represents the next significant milestone in our mission to deliver this important therapy to the broad PWS community, including those in the EU,' said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. 'Based on the data generated, DCCR has the potential to help treat hyperphagia, which is the most life-limiting aspect of PWS. We look forward to working closely with European regulators during the review process and intend to make DCCR available to patients in the EU as expeditiously as possible, if approved.' Confident Investing Starts Here:
Yahoo
21-05-2025
- Business
- Yahoo
Soleno Therapeutics to Participate in Upcoming June Conferences
REDWOOD CITY, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ('Soleno') (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it will participate in the following investor conferences in June: Jefferies Global Healthcare ConferencePresentation Date: Wednesday, June 4, 2025 at 10:30 AM ETPresentation Format: Corporate PresentationWebcast: Here Goldman Sachs 46th Healthcare ConferencePresentation Date: Tuesday, June 10, 2025 at 8:40 AM ETPresentation Format: Corporate PresentationWebcast: Here A replay of both events will be available in the Investors section on the Company's website at About Soleno Therapeutics, Inc. Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company's first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children four years of age and older with Prader-Willi syndrome. For more information, please visit Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578
