From the Journals
Clinical Guidelines
Conference News

This Week’s Biopharma News: Clinical Hold for Heart Disease Gene Therapy

Our latest news roundup reports on Novartis’ new radioligand facility in California, new tech for boosting AAV yields, and MeiraGTx’s deal with Eli Lilly

  • November 12, 2025

  • 5 min

Share

The FDA has imposed a clinical hold on Tenaya Therapeutics' TN-201 gene therapy trial for hypertrophic cardiomyopathy, requiring protocol amendments for patient monitoring and immunosuppression management. Concurrently, MeiraGTx has partnered with Eli Lilly to develop AAV gene therapies for retinal diseases, gaining substantial upfront and potential milestone payments. In industry advancements, Nanoform received a cGMP license for commercial drug manufacturing in the EU, and Novartis launched a new radioligand therapy facility in California. Additionally, CRISPR Therapeutics reported promising phase I trial results for CTX310, a gene-editing treatment targeting lipid levels, while Ascend Advanced Therapies unveiled enhancers to improve AAV vector yields for gene therapy production.

Related Content

Gut Microbes Signal CAD Risk

Metagenome analysis reveals strain-level functional differences and metabolic pathways that distinguish patients with coronary artery disease from healthy controls.

Dual Therapy for Coronary Disease: How Safe Is It? 

Adding aspirin to long-term oral anticoagulation in patients with chronic coronary syndrome increased mortality and major bleeding without improving cardiovascular outcomes.

Why Do Women Need Less Exercise for the Same Heart Benefit?

Accelerometer data from over 85,000 UK Biobank participants reveal significant sex differences in physical activity benefits for heart disease prevention and survival.