Axcella Health leaps 70% on UK regulator guidance on AXA1125 for long COVID fatigue

24 January 2023

Shares of US clinical-stage biotech Axcella Therapeutics (Nasdaq: AXLA) were up nearly 70% at $0.72 pre-market this morning, after it 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 UK’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. Axcella will be meeting with the MHRA in the near term to discuss the Innovative Licensing and Access Pathway (ILAP) application.

Axcella had also been studying AXA1125 as a treatment for non-alcoholic steatohepatitis (NASH), but last month revealed it will be discontinuing its Phase IIb trial in this indication.

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