Axcella Health (NASDAQ:AXLA) stock is on the rise Wednesday as investors react to an update from the Food and Drug Administration (FDA).
That update has to do with the company’s Long Covid Fatigue treatment currently in development. The FDA has granted the company approval to move forward with a Phase 2b/3 clinical trial of AXA1125.
With this news, Axcella Health has obtained approval from both the FDA and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) for its studies. Both agencies will provide guidance for the registration trial for patients with Long Covid Fatigue.
Jason Maley, M.D., Director of the Beth Israel Deaconess Medical Center Covid-19 Survivorship Program, said the following about the news:
“Treatment with AXA1125 resulted in statistically significant improvement in mental and physical fatigue scores, compared to placebo, in a well-designed and carefully conducted randomized controlled trial. I’m eager to see AXA1125 move into a phase 2b/3 study. This work is important to help patients with Long Covid who commonly experience debilitating daily fatigue.”
What This Means for AXLA Stock
Considering the previous success of its Long Covid Fatigue treatment in a Phase 2 clinical trial, this guidance is good news for the company. It puts it one step closer to regulatory approval in the U.S. and the U.K.
If Axcella Health sees further positive results, it could result in a commercial release of its treatment. That would bring in more revenue for the company, which would be a boon to shares of AXLA stock.
With today’s news comes heavy trading of AXLA stock. As of this writing, more than 8 million shares have changed hands. That’s well above the company’s daily average trading volume of about 1.3 million shares.
AXLA stock is up 35.3% as of Thursday morning.
Investors looking for more of the latest stock market news are in luck!
We’ve got all the most recent stock happenings for Thursday! That includes the biggest pre-market stock movers this morning, as well as the latest concerning Warren Buffett and Michael Burry investments to watch. You can find all that news at the following links!
More Thursday Stock Market News
- Today’s Biggest Pre-Market Stock Movers: 10 Top Gainers and Losers on Thursday
- Is Warren Buffett Giving Up on Taiwan Semiconductor (TSM) Stock?
- 8 Stocks Michael Burry Was Betting on Before Cryptic ‘Sell’ Warning
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.
With only the rarest exceptions, InvestorPlace does not publish commentary about companies that have a market cap of less than $100 million or trade less than 100,000 shares each day. That’s because these “penny stocks” are frequently the playground for scam artists and market manipulators. If we ever do publish commentary on a low-volume stock that may be affected by our commentary, we demand thatInvestorPlace.com’s writers disclose this fact and warn readers of the risks.
Read More: Penny Stocks — How to Profit Without Getting Scammed