By Chris Wack
Tenax Therapeutics shares doubled to 35 cents in premarket trading after the company said that the U.S. Food and Drug Administration has reviewed and cleared its Investigational New Drug Application for TNX-103 for the treatment of pulmonary hypertension with heart failure.
The FDA’s clearance allows the specialty pharmaceutical company to proceed with the first of two Phase 3 studies.
The study is expected to launch in the fourth quarter of 2023.
Tenax said that the clearance means it won’t be required to conduct a long-term, cardiovascular outcomes trial, which should significantly reduce costs and time to registration for TNX-103.
Write to Chris Wack at [email protected]
Read the full article here
