Applied Therapeutics CRL a ‘major setback,’ says William Blair

William Blair says Applied Therapeutics (APLT)’ complete response letter from the FDA for govorestat for the treatment of galactosemia is “unexpected and disappointing.” Given the lack of information in the CRL, it is unclear what the path forward for govorestat in galactosemia is and whether an additional clinical trial will be necessary for approval in this indication, the analyst tells investors in a research note. The firm says that while the rejection is a “major setback,” there is a possibility that a Type-A meeting with the FDA could provide clarity on the path forward. It keeps an Outperform rating on Applied Therapeutics. The stock in premarket trading is down 71%, or $6.12, to $2.45.