Verve Therapeutics said Monday that its experimental gene-editing treatment for a common form of heart disease was placed on clinical hold by the Food and Drug Administration, potentially delaying an ongoing, early-stage clinical trial.
The Cambridge, Mass.-based biotech had submitted a request to the FDA in October to allow participants in the U.S. to receive the CRISPR-based treatment, called VERVE-101, as part of its clinical trial program.
Verve said the FDA responded by placing VERVE-101 on clinical hold. No other details or explanation for the FDA’s action were provided Monday. In a statement, the company said it “plans to provide updates pending engagement with the FDA and intends to work closely with the FDA to resolve the hold as promptly as possible in order to initiate dosing in the U.S.”
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