Tenax Therapeutics Inc TENX shares are trading higher by 105% to $0.32 Monday morning after the company received FDA clearance of the IND for TNX-103, an oral levosimendan, to treat pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).
What Else?
Tenax Therapeutics says this clearance enables the launch of the Phase 3 LEVEL Study in fourth-quarter 2023. The FDA alignment streamlines the process, avoiding a long-term cardiovascular outcomes trial.
With no FDA-approved treatments for PH-HFpEF, Tenax says this addresses a significant medical need.
More than two-thirds of the targeted research sites for the LEVEL Study have already been selected, including leading cardiovascular centers in the United States and Canada.
The majority of sites that participated in the previous Phase 2 HELP study have agreed to take part in LEVEL.
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According to data from Benzinga Pro, TENX has a 52-week high of $4.30 and a 52-week low of $0.15.
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