Go or no go? Sarepta’s gene therapy faces scrutiny

One of biopharma's most highly anticipated approval processes of the year comes to a conclusion next month, when the fate of Sarepta’s Duchenne muscular dystrophy gene therapy will be determined. SRP-9001, partnered with Roche, has both an FDA panel and Pdufa date scheduled.

Elsewhere, two respiratory syncytial virus vaccines, Arexvy from GSK and Pfizer's Abrysvo, are expected to receive approvals in older adults. Pfizer’s candidate will also go before a panel in the infant setting. And Genmab and Abbvie’s epcoritamab, which boasts best-in-class potential in B-cell lymphoma, is looking good for an accelerated thumbs up.