This Week’s Biopharma News: Clinical Hold for Heart Disease Gene Therapy
November 12, 2025
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5 min
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.
1. FDA holds Tenaya's TN-201 trial for hypertrophic cardiomyopathy. 2. MeiraGTx collaborates with Eli Lilly for AAV therapies, receiving $75 million upfront. 3. Nanoform gets cGMP license for commercial drug manufacturing in the EU. 4. Novartis opens new radioligand facility in California. 5. CRISPR Therapeutics reports promising results from CTX310 gene-editing trial. 6. Ascend Advanced Therapies improves AAV vector yields with new enhancers.
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