Axcella Health (NASDAQ:AXLA) stock is rocketing higher on Tuesday after revealing a regulatory path to registration for AXA1125.
Investors will note that AXA1125 is the company’s treatment for Long Covid Fatigue. The Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.’s regulatory agency, has provided guidance to Axcella Health.
That guidance has the MHRA providing Axcella Health with a primary endpoint, key measurements, and more for a clinical trial of the drug. This guidance follows the submission of results from a Phase 2a clinical trial of AXA1125 as a Long Covid Fatigue treatment.
To go along with this news, Axcella Health is also planning further clinical trials of the treatment in the U.S. This has it submitting an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for a Phase 2b/3 clinical trial of the drug.
What This Means for AXLA Stock
If Axcella Health can continue to report positive results from clinical trials, AXLA stock is likely to benefit. The company is targeting a market that affects 15% to 20% of Americans that have experienced Covid-19.
This morning’s news also brings with it heavy trading of AXLA stock. As of this writing, more than 5 million shares have changed hands. That’s well above its daily average trading volume of 772,000 shares.
AXLA stock is up 66% as of Tuesday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.