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
For further details see:
Tenaya's gene therapy TN-201 for heart disorder gets FDA fast track tag