TNYA - Tenaya's gene therapy TN-201 for heart disorder gets FDA fast track tag

2023-05-02 09:14:34 ET

• The U.S. Food and Drug Administration (FDA) granted fast track designation to Tenaya Therapeutics' ( NASDAQ: TNYA ) gene therapy TN-201 being developed to treat Myosin Binding Protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM).
• HCM a condition in which the heart becomes thick that makes it hard for the heart to pump blood.
• The company noted that TN-201 is intended to deliver a fully functional MYBPC3 gene to restore normal levels of myosin-binding protein, which regulates the contraction and relaxation of the heart muscle.
• Tenaya is starting a phase 1b trial called MyPeak-1 to evaluate a one-time intravenous infusion of TN-201. The company expects to dose the first patient in Q3.
• TNYA +0.67% to $5.97 premarket May 2

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