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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Tenaya Therapeutics Inc | NASDAQ:TNYA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.28 | -6.25% | 4.20 | 4.20 | 4.79 | 4.54 | 4.14 | 4.54 | 179,517 | 05:00:03 |
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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