Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its gene therapy, Elevidys. Read more here.

As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are caught in the middle.

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause more deaths,

The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed gene therapy Elevidys.