Tuesday, February 15, 2022

Axcella Therapeutics (AXLA)
AXA1125 Receives Fast Track Designation For NASH Indication

Axcella Health Inc. is a clinical-stage biotechnology company focused on treating complex diseases and improvinge health using endogenous metabolic modulator, or EMM, compositions. Its product candidates are comprised of multiple EMMs that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. The company’s pipeline includes two lead therapeutic candidates:, AXA1665 for the reduction in risk of recurrent overt hepatic encephalopathy (OHE) , and AXA1125 for the treatment of non-alcoholic steatohepatitis (NASH).

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

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 …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision.