Leerink sees FDA decision to not hold Adcom as ‘very good news’ for Applied

Leerink notes that Applied Therapeutics announced it has completed its latecycle review with the FDA and that the FDA no longer intends to hold an Advisory Committee meeting for govorestat in galactosemia. The Adcom had been previously tentatively scheduled for October 9, 2024. The FDA also informed them that the priority review of the NDA is continuing as planned with a PDUFA date of November 28, 2024. Applied Therapeutics and the FDA also expect to reach alignment on post-marketing requirements in October 2024. The firm thinks this is very good news. The majority of clinical outcomes that would have been included in the original primary endpoint favored govorestat and only grew stronger when Applied Therapeutics updated its cognition data after calculations errors made by a vendor were discovered, Leerink adds. Collectively, the firm continues to think the galactosemia data are supportive of approval. Leerink has an Outperform rating on the shares.