Edgewise falls after FDA posts Warning Letter to trial investigator

Shares of Edgewise Therapeutics (EWTX) are moving lower after the FDA posted Warning Letter sent to Han Phan, a principal investigator for companies including Edgewise, Sarepta (SRPT), Fibrogen (FGEN) and Capricor (CAPR). The FDA says Phan “failed to ensure that the investigation was conducted according to the investi-gational plan.” It added, “We acknowledge that this finding was not included on the Form FDA 483 you received, and therefore your written responses do not address this violation. However, this finding was discussed with you during the inspection. You indicated during the inspection that one of the site assessors who performed several of these assessments was no longer employed at your clinical site. However, none of the site assessors appear to have undergone any retraining. Furthermore, no corrective or preventive actions to address this finding appear to have been taken or planned.” Phan is an investigator on Edgewise’s LYNX Phase 2 clinical trial at Rare Disease Research in Atlanta. The trial is examining the safety, pharmacokinetics and effect on biomarkers of muscle damage of EDG-5506 in children with Duchenne muscular dystrophy.