Fast Track Designation Is A Strong Positive. Axcella announced that the FDA has granted Fast Track Designation for AXA1125 in its non-alcoholic steatohepatitis (NASH) with fibrosis indication. AXA1125 is a formulation of amino acids in development to resolve NASH by controlling metabolic, inflammatory, and fibrotic pathways. AXA 1125 is currently in the Phase 2b EMMPACT clinical trial for the NASH indication.Fast Track Designation Signifies Recognition Of Potential Impact. AXA1125 was granted Fast Track Designation after the FDA reviewed clinical data from the previous studies. This designation is intended to assist development and shorten time to market by allowing the company to have more frequent communications about clinical plans and requirements. It can also allow for rolling submission and review of the application, shortening review time.The Phase 2b EMMPACT Study Is Making Progress. In April 2021, Axcella began a Phase 2b trial for AXA1125 in NASH known as EMMPACT. The trial compares two doses of AXA1125 against placebo and has an expected enrollment of about 270 patients. The company reported that the study is enrolling well, and is on schedule for an interim data announcement in mid-2022.Phase 2a In Long COVID Is Progressing. AXA1125 is in a separate Phase 2a trial for Long COVID. This trial has a planned enrollment of about 40 patients with symptoms of exertional fatigue (fatigue, muscle aches, shortness of breath). AXA1125 has shown beneficial impacts on mitochodrial dysfunction that may correct the abnormal metabolism seen in Long COVID. Preliminary data is expected around mid-2022.Conclusion: We see the Fast Track Designation as a strong positive for AXA1125 that signifies the FDA recognizes that it could fill an unmet medical need and provide a beneficial therapy where none exists. We are reiterating our Outperform rating and price target of $10 per share. Read More >>