The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.

Allogene hopes its off-the-shelf CAR-T can begin a potentially pivotal Phase II study by the end of this year but is frustrated by an “under-resourced and overworked FDA.”

Janssen priced the one-time autologous treatment at $465,000, well above the $419,500 list price for Bristol’s first-to-market CAR-T, but expects broad commercial and Medicare coverage.