Sarep­ta march­es for­ward with its po­ten­tial DMD gene ther­a­py and an ex­pand­ed Catal­ent man­u­fac­tur­ing deal

Sarep­ta spent much of last year march­ing for­ward with its can­di­date SRP-9001, a gene ther­a­py treat­ment for the rare but fa­tal Duchenne mus­cu­lar dy­s­tro­phy, even­tu­al­ly fil­ing a BLA for an ac­cel­er­at­ed ap­proval, with a May 29 PDU­FA date and a like­ly ad­comm on the way too.

The Cam­bridge, MA-based biotech on Thurs­day signed a com­mer­cial sup­ply agree­ment with the New Jer­sey-based CD­MO Catal­ent to man­u­fac­ture SRP-9001 and to sup­port oth­er gene ther­a­py can­di­dates in Sarep­ta’s pipeline for an­oth­er rare, ge­net­ic dis­ease re­lat­ed to mus­cle de­te­ri­o­ra­tion, known as limb-gir­dle mus­cu­lar dy­s­tro­phy (LGMD). Fi­nan­cial de­tails of the deal were not dis­closed and End­points News did not hear back from Catal­ent by press time.

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