The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could further jeopardize Sarepta’s financial future.

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.

The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta Therapeutics (NASDAQ: SRPT) gene therapy, Elevidys, for Duchenne muscular dystrophy (DMD).