CARsgen Therapeutics Holdings Limited announced that responses regarding the status of the Corrective and Preventive Actions (CAPAs) plan have been submitted to the U.S. Food and Drug Administration (FDA). This submission is related to the observations identified in the Form 483 issued after the FDA inspection in December 2023 of clinical manufacturing site in Durham, North Carolina. All relevant works are progressing smoothly according to the previously committed timetable.

The Company is committed to working closely with the FDA to prioritize quality in production during clinical trials.