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<a href="https://smartkarma.com/entities/soleno-therapeutics-inc">Soleno Therapeutics </a>has achieved a major milestone with the recent FDA approval of its lead drug, VYKAT™ XR (diazoxide choline extended-release tablets), for the treatment of hyperphagia (excessive hunger) in patients with Prader-Willi Syndrome (PWS). This marks the first approved therapy specifically for this debilitating symptom of the rare genetic disorder, representing a significant commercial opportunity.</li>
  <li>The company is now transitioning to a commercial-stage entity, with the U.S. launch of VYKAT™ XR expected to commence in April 2025. This pivotal shift from a clinical-stage to a revenue-generating company is a key inflection point for Soleno.</li>
  <li>While the FDA approval is a major de-risking event, the company's future success will depend on a successful commercial launch, market adoption by physicians and patients, and navigating the competitive landscape of potential future treatments for PWS.</li>
</ul><p><em>This content is AI-generated and displayed for general informational purposes only. Please verify independently before use.</em></p>


  
Soleno Therapeutics has achieved a major milestone with the recent FDA approval of its lead drug, VYKAT™ XR (diazoxide choline extended-release tablets), for the treatment of hyperphagia (excessive hunger) in patients with Prader-Willi Syndrome (PWS). This marks the first approved therapy specifically for this debilitating symptom of the rare genetic disorder, representing a significant commercial opportunity.
  The company is now transitioning to a commercial-stage entity, with the U.S. launch of VYKAT™ XR expected to commence in April 2025. This pivotal shift from a clinical-stage to a revenue-generating company is a key inflection point for Soleno.
  While the FDA approval is a major de-risking event, the company's future success will depend on a successful commercial launch, market adoption by physicians and patients, and navigating the competitive landscape of potential future treatments for PWS.
This content is AI-generated and displayed for general informational purposes only. Please verify independently before use.

Primer: Soleno Therapeutics  (SLNO US) - Nov 2025

United States

Soleno Therapeutics, Inc. is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.

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Primer: Soleno Therapeutics (SLNO US) - Nov 2025

Soleno Therapeutics has achieved a major milestone with the recent FDA approval of its lead drug, VYKAT™ XR (diazoxide choline extended-release...

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