FDA places hold on Tenaya’s heart‑gene trial over immunosuppression standardization

The FDA issued a clinical hold on a Tenaya Therapeutics gene therapy trial while the company standardizes immunosuppression protocols across study sites. Tenaya said it is addressing the agency’s concerns about regimen consistency and site practices before resuming enrollment. The pause affects a cardiac gene‑therapy program intended for heart disease and underscores regulatory scrutiny of immunomodulation management in systemic gene‑therapy studies.