Tenaya Therapeutics announces TN-201 FDA IND clearance

Tenaya Therapeutics announced that the U.S. Food and Drug Administration, FDA, has provided clearance of its Investigational New Drug, IND, application to initiate clinical testing of TN-201. In addition, Tenaya shared anticipated 2023 program milestones and updated cash runway guidance. "Tenaya had a momentous year in 2022 in which we filed two INDs, transitioned into a clinical-stage company, launched operations of our Genetic Medicines Manufacturing Center – where we successfully produced clinical drug supply for TN-201 – and significantly extended our cash runway," said Faraz Ali, Chief Executive Officer of Tenaya. "We are pleased to start 2023 with clearance of the IND for our TN-201 gene therapy program and look forward to dosing patients with MYBPC3-associated HCM in our Phase 1b study in the coming months. We are also starting 2023 with confirmation of target engagement in our TN-301 Phase 1 study and look forward to reporting clinical data for this program later this year. We are enrolling patients across three non-interventional studies for our gene therapy programs and plan to file an IND for TN-401. Taken altogether, we are making tremendous strides on our mission and are solidifying our leadership position in the field of precision medicine therapies for heart disease."