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TNYA Tenaya Therapeutics Inc

4.20
-0.28 (-6.25%)
11 May 2024 - Closed
Delayed by 15 minutes
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

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

02/05/2023 1:43pm

Dow Jones News


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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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