Latest news with #AnishBhatnagar
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
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
