Latest news with #Soleno
Yahoo
22-05-2025
- Business
- Yahoo
Soleno Therapeutics Announces Submission and EMA Validation of Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome
REDWOOD CITY, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Soleno's Marketing Authorization Application (MAA) seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets (previously referred to as DCCR) for the treatment of adults and children four years and older with Prader-Willi syndrome (PWS) who have hyperphagia had been validated by the European Medicines Agency (EMA). '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.' Soleno estimates that there are approximately 9,500 patients with PWS in the United Kingdom, France, Germany, Italy and Spain combined1. The Company has been granted Orphan Drug Designation for diazoxide choline in the EU for the treatment of PWS, which could provide Soleno with up to 10 years of market exclusivity in the EU, if approved, in addition to certain other regulatory and financial incentives. DCCR was approved by the U.S. Food and Drug Administration (FDA) under the brand name VYKAT™ XR on March 26, 2025. About PWSPrader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease. U.S. INDICATIONVYKAT XR is indicated in the U.S. for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). ________________________________ 1 Based on mid-point of Orphanet Birth Prevalence rate of 1 in 15,000 to 30,000 IMPORTANT SAFETY INFORMATION ContraindicationsUse of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides. Warnings and Precautions HyperglycemiaHyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia. Risk of Fluid OverloadEdema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients. Adverse ReactionsThe most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. Please see the full Prescribing Information, including Medication Guide. About Soleno Therapeutics, 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 4 years of age and older with Prader-Willi syndrome and was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the regulatory approval process for Diazoxide Choline Prolonged-Release Tablets in the EU, the timing of commercialization of Diazoxide Choline Prolonged-Release Tablets in the EU, the potential market opportunity for Diazoxide Choline Prolonged-Release Tablets and the ability of Diazoxide Choline Prolonged-Release Tablets to address the unmet needs of the PWS community. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578 Media Contact:media@ 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
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
Yahoo
27-03-2025
- Health
- Yahoo
Soleno wins FDA approval for Prader-Willi hyperphagia treatment
Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as Vykat XR – to treat extreme hunger in patients with Prader-Willi syndrome. This approval follows a three-month delay from the FDA. In November 2024, the agency classified responses from Soleno as a 'major amendment' to its new drug application (NDA), requiring additional time to review. However, the agency did not raise concerns about the drug's safety, efficacy, or manufacturing. Prader-Willi syndrome is a rare genetic disorder caused by abnormalities in chromosome 15. Symptoms include low muscle tone, developmental delays, and behavioural challenges. Extreme hunger – known as hyperphagia, is one of the most serious and defining characteristics of the disorder and can lead to severe obesity and associated health complications if unmanaged. Vykat XR is now the only FDA-approved treatment specifically addressing hyperphagia in Prader-Willi syndrome. The FDA approval of Vykat XR was based on data from the Phase III Study C602-RWP clinical trial (NCT03714373). Efficacy was demonstrated during a 16-week randomised withdrawal study period. Patients who switched to a placebo demonstrated a statistically significant worsening of hyperphagia compared to those who remained on Vykat XR. The drug was also studied in the Phase III DESTINY-PWS trial (NCT03440814), which enrolled 127 individuals with genetically confirmed Prader-Willi syndrome. The trial did not demonstrate a statistically significant difference in hyperphagia reduction overall, but Soleno reported 'nominally significant' reductions in fat mass, and general improvements in condition as assessed by investigators. Vykat XR is set to launch in the US in April 2025, according to Soleno's 26 March announcement. Vykat XR – an extended-release tablet containing a crystalline salt formulation of diazoxide – works by activating the adenosine triphosphate (ATP)-sensitive potassium (KATP) channel, which plays a role in hunger regulation. The approval was welcomed by the Prader-Willi Syndrome Association: 'Today marks a historic day for the PWS community. The FDA's approval of Vykat XR represents a monumental step forward in addressing the longstanding unmet needs of individuals living with PWS and their families,' said Stacy Ward, CEO of the Association. Soleno also has its eyes set on Europe, having announced previously that it plans to file for approval of Vykat XR in the EU in the first half of 2025. According to GlobalData's Pharma Intelligence Center, Vykat XR is set to generate $876m in sales by 2030. GlobalData is the parent company of Pharmaceutical Technology. "Soleno wins FDA approval for Prader-Willi hyperphagia treatment" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
