Catalent had 483s cleared, removing overhang, says Barclays

Barclays analyst Luke Sergott notes that the FDA cleared Catalent (CTLT) of Form 483s for its Belgium and Bloomington facilities’ over the holiday weekend with Voluntary Action Indicated designations, which means that there are no warning letters at the facilities, which he adds "was a big overhang for the stock." Investors had been concerned that there would be another guide-down if either facility was shut down and given that this was not the case, he looks at its FY23 guidance as "achievable," though still weighted to the second half. Separately, Sarepta Therapeutics (SRPT) announced that the FDA has accepted the company’s Biologics License Application seeking accelerated approval of SRP-900 for the treatment of ambulant individuals with Duchenne muscular dystrophy, which Sergott said represents "pure upside" potential in 2024 and 2025 given that Catalent has previously stated that it does not assume FDA approval for any of its customers’ drugs. Sergott has an Overweight rating and $62 price target on Catalent shares.