Axcella Announces MHRA Regulatory Path for AXA1125

(24/7 MARKET NEWS) – Axcella Therapeutics (Nasdaq: AXLA) announced, this morning, that it received regulatory guidance from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), 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 also submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for a Phase 2b/3 trial.

Axcella Therapeutics is trading at $0.63, 20-cents higher (+46.51%), on volume of 7.6 million shares traded.

Its 52-week range is $0.1621 to $2.89. Its premarket high is $0.89.

View source version: https://www.businesswire.com/news/home/20230123005745/en/

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