MaaT Pharma says EU drug panel maintains negative opinion on Xervyteg conditional approval

EMA’s CHMP upheld a negative opinion on conditional approval for Xervyteg in refractory gastrointestinal acute graft-versus-host disease. Regulators cited insufficient benefit-risk evidence from the single-arm dataset, keeping EU authorization at risk pending the Commission’s decision. Development focus shifts to the PHOENIX randomized Phase 3 trial versus best available therapy, designed to support US and EU filings. FDA Type C feedback backs PHOENIX as a registrational study, with first patient enrollment targeted for H1 2027. Cash-preservation measures extended the cash runway to December 2026 from November 2026. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Maat Pharma SA published the original content used to generate this news brief via (Ref. ID: 202609180130BIZWIRE_USPR_____20260917_BW925040) on September 18, 2026, and is solely responsible for the information contained therein. (C)