Tenaya Therapeutics Gets FDA Fast-Track Designation for TN-201

By Colin Kellaher

Tenaya Therapeutics on Tuesday said the U.S. Food and Drug Administration granted fast-track designation to its TN-201 gene-therapy product candidate for certain patients with the most common inherited cardiac disorder.

The South San Francisco, Calif., clinical-stage biotechnology company said the designation covers TN-201 in patients who have hypertrophic cardiomyopathy caused by mutations in the myosin binding protein C3, or MYBPC3, gene.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Tenaya said MYBPC3-associated hypertrophic cardiomyopathy accounts for about 20% of all cases of the disorder, affecting roughly 115,000 people in the U.S.

The company expects to begin dosing in a Phase 1 study of TN-201 in the third quarter.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

05-02-23 0828ET