The U.S. Food and Drug Administration placed a clinical hold on a Tenaya Therapeutics gene‑therapy trial while the company standardizes immunosuppression regimens across sites. The pause affects early clinical activity for Tenaya’s cardiovascular program and forces the sponsor to align site practices and dosing protocols before dosing can resume. Tenaya must provide the agency with harmonized immunosuppression procedures and oversight updates; the hold underscores regulator focus on consistent peri‑trial management when gene therapies carry immune risks. The delay will shift timelines for enrollment and potential readouts while the company addresses the agency’s requests.