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Latest news with #DiazoxideCholineProlonged-ReleaseTablets

Soleno Therapeutics seeking regulatory approval in treatment of PWS
Soleno Therapeutics seeking regulatory approval in treatment of PWS

Yahoo

time23-05-2025

  • 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

Soleno Therapeutics seeking regulatory approval in treatment of PWS
Soleno Therapeutics seeking regulatory approval in treatment of PWS

Business Insider

time23-05-2025

  • 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:

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