Soleno Therapeutics (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel treatments for rare diseases, announced on April 7, 2026, that it has voluntarily withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for VIOKAT prolonged-release tablets.
The medicinal product, marketed in the United States as VYKAT™ XR (diazoxide choline), was under regulatory review for the treatment of hyperphagia—an insatiable hunger—in adults and children aged four years and older with Prader-Willi syndrome (PWS).
The company had previously signaled that a regulatory decision from the EMA’s Committee for Medicinal Products for Human Use (CHMP) was expected by mid-2026.
Soleno stated that the decision to withdraw the application was based on internal business and strategic considerations rather than concerns regarding the safety or efficacy profile of the drug.
By voluntarily pulling the application at this stage, the company preserves its ability to re-submit or re-engage with European regulators at a later date if an alternative pathway or strategic partnership becomes more viable.
In the United States, VYKAT XR remains commercially available following its FDA approval.
The drug serves a critical unmet need for the PWS community, as hyperphagia is a leading cause of morbidity and reduced quality of life for those living with the genetic disorder.
The U.S. launch has been a primary driver of Soleno's recent revenue growth, and management indicated that the European withdrawal does not impact its domestic commercial operations or supply chain.