Business
Tenaya Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update
TN-201 Received Orphan Medicinal Product Designation from the European Commission Preclinical TN-401 Data Presented at Heart Rhythm 2022 SOUTH SAN FRANCISCO,
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"\nTN-201 Received Orphan Medicinal Product Designation from the European Commission\n\nPreclinical TN-401 Data Presented at Heart Rhythm 2022\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nTenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today provided business and program updates, and reported financial results for the first quarter ended March 31, 2022.\n\n“Tenaya continues to advance a broad pipeline of potentially first-in-class programs for both rare and prevalent forms of heart disease,” said Faraz Ali, Chief Executive Officer of Tenaya. “Our progress is measurable across all aspects of our business. We recently presented encouraging preclinical data for our emerging gene therapy program, TN-401, being developed for the treatment of genetic arrhythmogenic right ventricular cardiomyopathy. Our IND-enabling efforts for TN-201 and TN-301 are on track, as are efforts for our cGMP manufacturing facility to become operational. We are also pleased to announce that TN-201 has been granted orphan drug designation in Europe.”\n\nRecent Business and Program Updates\n\nTN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy (HCM)\n\n\nTN-201 received Orphan Medicinal Product designation from the European Commission for the treatment of HCM due to mutations in the MYBPC3 gene. TN-201 has also received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).\n\n\nTenaya expects to submit an Investigational New Drug (IND) application for TN-201 to the FDA in the second half of 2022.\n\n\nTN-401 – PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)\n\n\nTenaya presented preclinical data at the Heart Rhythm Society’s annual Heart Rhythm 2022 meeting for its investigational PKP2 gene therapy, TN-401. In a preclinical study using a Pkp2 knockout mouse model to assess prevention of disease onset and progression, a single dose of PKP2 gene therapy restored heart function, reduced the occurrence of severe arrythmia, prevented adverse remodeling and fibrosis, and significantly increased survival.\n\n\nTenaya expects to submit an IND application for TN-401 to the FDA in 2023.\n\n\nTN-301 – HDAC6 Small Molecule Inhibit...