Catalent confirms being Regeneron’s Eylea 8 mg third party filler, says Stephens

Stephens notes that Catalent (CTLT) confirmed to Endpoint News and Bloomberg that its Bloomington facility recently underwent a “scheduled pre-approval inspection for aflibercept 8 mg., during which the regulator made three observations,” which confirms investor concerns that Catalent was responsible for the CRL at Regeneron (REGN) related to the BLA for aflibercept 8 mg, or high-dose Eylea. It is “hard to precisely say at this point” what this means for Catalent, according to the firm, but among its “preliminary thoughts” are the fact that this is “another high profile therapy impacted by inspection findings” at a company site, which Stephens calls “not a great look.” The delay around the approval of aflibercept 8 mg may represent some risk to FY24 expectations and this news “brings additional noise” to the Catalent story and likely fuels investor concerns around new business development given recent headlines, added the analyst, who has an Overweight rating and $50 price target on Catalent shares.