Sarepta Therapeutics announced that it has signed a commercial supply agreement with CDMO giant Catalent to manufacture SRP-9001, Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).

The U.S. FDA accepted Sarepta’s BLA seeking accelerated approval of SRP-9001 for the treatment of ambulant individuals with DMD back in November. The therapy was granted Priority Review and given a regulatory action date of May 29, 2023.

SRP-9001 (delandistrogene moxeparvovec) is an investigational gene therapy for Duchenne being developed in partnership with Roche. Massachusetts-based Sarepta is responsible for global development and manufacturing and plans to commercialize SRP-9001 in the U.S. upon receiving FDA approval. Back in Dec. 2019, Roche handed over $1.15 billion to obtain the rights to the drug outside the U.S.

If approved in May, SRP-9001 will be the first gene therapy for Duchenne — a one-time treatment designed to treat the underlying cause of DMD by delivering a functional shortened dystrophin to muscle tissue.

Catalent’s gene therapy network includes state-of-the-art facilities that currently house 10 CGMP gene therapy manufacturing suites, with another 8 suites under construction, each capable of accommodating multiple bioreactors up to 2,000-liter scale. The agreement with Sarepta also structures how Catalent may support multiple gene therapy candidates in Sarepta’s pipeline for limb-girdle muscular dystrophy (LGMD).