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.
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Read More on APLT:
- Applied Therapeutics downgraded to Sector Perform from Outperform at RBC
- Applied Therapeutics down 84% after receiving CRL from FDA on NDA for govorestat
- Applied Therapeutics trading resumes
- Applied Therapeutics’ NDA for govorestat receives negative response from FDA
- Applied Therapeutics trading halted, news pending
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
