Roche Pauses Contested Gene Therapy’s Shipments Outside US

(Bloomberg) — Roche Holding AG paused some shipments of the controversial gene therapy Elevidys following a similar action by the embattled US biotechnology company that developed the treatment.

The Swiss drugmaker said the move applies to new orders in countries outside the US that base their approvals on Food and Drug Administration decisions. It covers all patients with Duchenne muscular dystrophy, a muscle-wasting disease, regardless of their ability to walk.

Roche described the pause as voluntary and temporary in an emailed statement late Tuesday. The shares rose as much as 1.9% in early Zurich trading on Wednesday, helping them clock a small gain for the year so far.

Sarepta Therapeutics Inc., which developed Elevidys to treat DMD and sells it in the US, announced a temporary halt on shipments there late Monday. Two teenage boys died of acute liver failure in recent months after taking the drug.

The FDA asked Sarepta to pause shipments of Elevidys last week after news reports of a patient death in a clinical trial for another drug that works in a similar way. The US biotech initially refused to do so, then reversed course after a backlash.

Roche markets Elevidys outside the US, with the drug currently approved in countries including the United Arab Emirates, Qatar and Kuwait. It’s still under regulatory review in Europe. Analysts had expected Roche’s share of the revenue to clear the $1 billion blockbuster hurdle in 2030.

The pause also applies to individual patients who may have been getting the gene therapy before it was formally approved in their countries.

A one-time treatment, Elevidys is designed to introduce a gene into the body to produce a version of the protein that people with Duchenne lack.

The teenagers who died after taking the treatment were both unable to walk, and Roche and Sarepta had already paused use of the medicine for patients who can’t walk. Most of the children who have taken the treatment so far have been younger and are still able to walk.

Roche believes the risk-benefit profile is positive for these patients and said it will continue to ship Elevidys to countries like Brazil and Japan that don’t reference the FDA for approval.

(Updates with Roche shares in second paragraph, other countries in last)

©2025 Bloomberg L.P.