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

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