Axcella Up 65% After Announcing Regulatory Path To Registration Of AXA1125 For Long COVID Fatigue

(RTTNews) - Shares of Axcella Therapeutics (AXLA) surged over 65% in extended session on Monday after the clinical-stage biotechnology company announced a regulatory path to registration of AXA1125 in the treatment of Long COVID Fatigue.

The company reported that it had received regulatory guidance from The Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.'s regulatory agency, supporting a single trial that could serve as the registration trial for patients with Long COVID fatigue, and aligning on key measurements, including primary endpoint and trial design.

The company further reported submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for a Phase 2b/3 trial.