Why Axcella Health (AXLA) Shares Are Trading Higher Premarket Today?

Axcella Health Inc AXLA announced a regulatory path to the registration of AXA1125 for Long COVID Fatigue.
The company 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.
Axcella will meet with the MHRA soon to discuss the Innovative Licensing and Access Pathway (ILAP) application. The company submitted an Investigational New Drug (IND) Application to the FDA for a Phase 2b/3 trial.
In August, the company announced results from the Phase 2 study of AXA1125 in patients with fatigue related to Long COVID. Subjects who received AXA1125 experienced clinically and statistically significant improvement in mental and physical fatigue scores compared to placebo subjects.
In December, Axcella Health announced organizational and program updates, including a reprioritization of its programs for Long COVID Fatigue and Nonalcoholic Steatohepatitis (NASH) and restructuring operations.
Axcella announced discontinuing its Phase 2b trial of AXA1125 in NASH while keeping the option to revisit this program should resource availability change.
Price Action: AXLA shares are up 66.3% at $0.72 during the premarket session on the last check Tuesday.

Why Are Axcella Health Shares Gaining Today?