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Applied Therapeutics’ Pivotal Galactosemia Product Stalls, Confirming Analyst Concerns

 
• By Ayisha Sharma

Analysts’ fears have been confirmed as a US FDA demand for clinical outcomes data has forced Applied Therapeutics to delay a planned filing for its lead product candidate, AT-007, in the rare disease galactosemia based on biomarker data alone.  

Female orthopedist examining little child's foot condition in clinic.
Galactosemia Is A Rare Condition That Can Cause Poor Motor Skills • Source: Alamy

Applied Therapeutics Inc. has put a hold on a planned US filing for its galactosemia candidate, AT-007, because of a shift in US Food and Drug Administration approval parameters that means that biomarker data alone will not be enough, reinforcing worries expressed earlier by some analysts.

The firm’s share price fell by 30.5% to close at a $6.22 on the NASDAQ on 3 January with the delay to market of one of its lead products

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