Tenaya Therapeutics Gets FDA Fast-Track Designation for TN-201
May 02 2023 - 8:43AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 02, 2023 08:28 ET (12:28 GMT)
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