Applied Therapeutics initiated with an Outperform at Leerink

Leerink analyst Joseph Schwartz initiated coverage of Applied Therapeutics with an Outperform rating and $12 price target. While Applied Therapeutics has faced a bumpy road in galactosemia, it has successfully filed NDA and MAA submissions with the FDA and EMA, respectively, which sets them up for potential approvals in mid-2024, Leerink says. The MAA has been validated, and the firm expects the NDA to be accepted for review in the coming days. Despite missing the primary endpoint in the galactosemia study, Leerink views the significant reduction in galactitol and consistent improvements across several clinical outcomes as supportive of approval, particularly in the context of a new division director who appears to be supportive of the totality of the data, support from a strong patient advocacy group, and lack of other treatment options.