Regeneron 483 issues might not require reinspection, says Morgan Stanley

Noting that Regeneron (REGN) recently disclosed a CRL for the high dose Eylea BLA application due to an ongoing review of inspection findings at a third party filler, Morgan Stanley analyst Terence Flynn said the firm does not have independent confirmation from Catalent (CTLT) that it is the filler in question, but also noted that the FDA site now indicates 483 observations at the Bloomington facility for an inspection dated May 12, 2023. After speaking with a regulatory consultant regarding this 483 letter, the firm noted that the consultant believes that the issues outlined in the 483 letter can likely be quickly addressed by Catalent and might not require an FDA re-inspection, which the firm found “encouraging,” but it also added “we caveat that this is the opinion of one consultant, who reviewed a redacted 483 document.” The firm has an Overweight rating on Regeneron shares.