Tenax Therapeutics Inc (NASDAQ: TENX) is starting the day on an incredibly strong note after releasing the results of a pre-IND meeting with the United States Food & Drug Administration (FDA). Of course, the result of the meeting proved to be positive. The excitement is brewing and TENX is up in a massive way. Today, we’ll talk about:
- The result of the meeting with the FDA;
- what we’re seeing from the stock;
- and what we’ll be watching for with regard to TENX ahead.
TENX Heads For The Top After Announcing Meeting Results
As mentioned above, Tenax Therapeutics is having an incredibly strong start to the trading session after announcing the result of a meeting with the FDA. In a press release issued early this morning, the company announced the results of its pre-Investigational New Drug (pre-IND) meeting with the FDA. During the meeting, regulatory body that oversees medication in the United States addressed questions posed by TENX and provided guidance with regard to an upcoming Phase 2 clinical trial.
The upcoming Phase 2 trial covers the use of levosimendan for the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). In the release, TENX announced that the FDA has agreed that the new Phase 2 protocol can be submitted under the existing IND. The regulatory body also said that it supported the study design and endpoints for demonstrating proof-of-concept in PH-HFpEF patients. In a statement, Michael Jebsen, Interim CEO at TENX, had the following to offer:
We are very pleased with the outcome of the pre-IND meeting… The initial pathway to move forward with the development of levosimendan in PH-HFpEF has been clarified and confirmed. We will finalize our Phase 2 clinical trial protocol for IND submissions and continue preparations for a late June or July start of the trial.
What We’re Seeing From The Stock
With such overwhelmingly positive news, the Tenax Therapeutics is having an overwhelmingly positive day in the market, and it makes sense. After all, the FDA not only will allow for the new protocol to be submitted under the existing IND, the regulatory body has given its thumbs up when it comes to the protocol surrounding the primary endpoints of the trial. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:49), TENX is trading at $11.75 per share after a gain of $6.43 per share or 120.86% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on TENX. In particular, we’re interested in following the story surrounding the company’s upcoming Phase 2 trial as well as the development in the Phase 3 trial of the same treatment for LCOS prevention in high risk cardiac surgery. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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