By Denny JacobAxcella Health Inc. shares surged 53% to 66 cents in after-hours trading Monday after the company said it received regulatory guidance from the U.K.'s regulatory agency for AXA1125 as a treatment for long Covid fatigue. The clinical-stage biotechnology company said the Medicines and Healthcare products Regulatory Agency issued guidance supporting a single trial that could serve as the registration trial for patients with long Covid fatigue. It said it will meet with the agency in the near term to discuss the innovative licensing and access pathway application. Axcella also said it reported submission of an investigational new drug application to the U.S. Food and Drug Administration for a Phase 2b/3 trial. Write to Denny Jacob at denny.jacob@wsj.com(END) Dow Jones NewswiresJanuary 23, 2023 16:48 ET (21:48 GMT)Copyright (c) 2023 Dow Jones & Company, Inc.

Source: Wall Street Journal January 24, 2023 04:04 UTC