Applied Therapeutics reported financial results for the fourth quarter and full year ended December 31, 2020, with a focus on advancing late-stage assets toward commercialization and initiating clinical development of new rare disease programs.
AT-007 ACTION-Galactosemia Kids pediatric clinical study recently resumed following discussions with FDA.
Company is on track to submit NDA for AT-007 in Galactosemia no later than Q3 2021; Commercial preparations underway.
ARISE-HF Phase 3 global registrational study of AT-001 in Diabetic Cardiomyopathy is on track to complete enrollment in mid-2021.
Company is on track to initiate rare disease franchise expansion programs in SORD Deficiency and PMM2-CDG studies in the first half of 2021.
The company is focused on advancing its late-stage assets toward commercialization while initiating clinical development of its two new rare disease programs.