Shares of Tenax Therapeutics surged over 300% after it announced the US Food and Drug Administration (FDA) has reviewed and cleared its Investigational New Drug (IND) application for its hypertension candidate, TNX-103.
The specialty pharmaceutical company said the FDA's decision enables it to proceed with the first of two Phase 3 studies for TNX-103 (oral Levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).
The LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) is expected to launch in the fourth quarter of 2023, it added.
“We could not be more pleased with the results of our collaborative, productive discussions with the FDA, which provide a clear path to starting LEVEL, including mutual alignment with respect to the primary efficacy endpoint and expected patient enrollment,” Tenax president and CEO Chris Giordano said.
“Importantly, Tenax will not be required to conduct a long-term, cardiovascular outcomes trial, which should significantly reduce our costs and time to registration for TNX-103."
Along with its contract research organization partner, Tenax said it has already selected more than two-thirds of the research sites targeted to participate in the LEVEL Study, including many of the leading cardiovascular centers in the US and Canada.
The company’s shares traded 330% higher at $0.67 shortly after midday in New York.
Contact the author at stephen.gunnion@proactiveinvestors.com