Business
Tenax Therapeutics Reports Third Quarter 2021 Results and Provides Business Update
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":" MORRISVILLE, N.C.--(BUSINESS WIRE)--\nTenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today reported financial results for the third quarter of 2021 and provided a business update.\n\n“As we approach the new year, the Tenax team is building strong momentum across our lead clinical programs,” said Christopher T. Giordano, President and Chief Executive Officer of Tenax Therapeutics. “In October, we announced the initiation of a comparative pharmacokinetic study designed to evaluate our novel formulation of imatinib versus the currently approved formulation. We expect this trial to be completed by year-end. It will serve as a bridging study for our registration-enabling Phase 3 trial in pulmonary arterial hypertension, or PAH. Based on our current timeline, we expect this Phase 3 study to begin in the second quarter of 2022. In our view, there is a growing recognition that by reformulating oral imatinib, a drug already clinically proven to benefit PAH patients, Tenax has an opportunity to introduce the first safe and effective treatment for PAH with the potential for disease-modifying activity.”\n\n“Our open label transition study using the oral formulation of levosimendan also remains on track. As a reminder, this trial is being conducted to help Tenax determine the optimal dosage for levosimendan in our planned Phase 3 trial, which also is expected to start in 2022. In sum, Tenax is entering an exciting period in the Company’s history, with the potential for initiating two registration-enabling studies in the next several months. We thank our investors for their continued support, and we look forward to providing additional updates in the near future.”\n\nRecent Highlights\n\n\nReceived FDA notice of clearance of the Investigational New Drug (IND) application for the Company’s novel formulation of imatinib.\n\n\nInitiated, and plans to complete before the end of 2021, a comparative pharmacokinetic (PK) study bridging to the start of a Phase 3 trial of the Company’s delayed-release formulation of imatinib for the treatment of PAH.\n\n\nAnnounced the publication of a new article that identifies a novel mechanism of action behind the improved cardiovascular hemo...