04/07/2026 | Press release | Distributed by Public on 04/07/2026 04:59
| ITEM 8.01 |
Other Events |
On April 7, 2026, Soleno Therapeutics, Inc. (the "Company") reported that it has voluntarily withdrawn its marketing authorization application ("MAA") for VIOKAT prolonged-release tablets (diazoxide choline), which is marketed in the United States as VYKATTM XR, its medicinal product for the treatment of adults and children aged 4 years and older with Prader-Willi syndrome ("PWS") who experience hyperphagia. The Company had previously announced that the application has been under review by the European Medicines Agency ("EMA"), with a decision expected in mid-2026.
The Company's decision to withdraw the MAA is based on business and strategic considerations. Withdrawal of the application preserves the Company's ability to re-engagewith regulators at a later date should there be an appropriate pathway to progress the program.