US regulators have allowed patients who can walk to resume taking Sarepta’s gene therapy Elevidys. This decision reverses the FDA’s previous request to pause all shipments of the drug, which was prompted by three deaths linked to its treatments. The FDA’s change comes 10 days after the company initially refused to halt shipments due to concerns about safety and revenue impact on debt payments.
Source: https://www.bloomberg.com/news/articles/2025-07-28/fda-says-sarepta-can-treat-ambulatory-patients-with-gene-therapy?srnd=all