Applied Therapeutics

Applied Therapeutics to Present Extended INSPIRE Trial Data for Govorestat in SORD Deficiency at PNS Annual Meeting

13 days ago

• Applied Therapeutics will present full 12-month results from the Phase 3 INSPIRE trial of govorestat for SORD Deficiency at the Peripheral Nerve Society 2025 Annual Meeting in Edinburgh, Scotland. • The presentation will include new topline 18-month and 24-month data from the double-blind, placebo-controlled registrational trial, extending beyond the previously reported 12-month results. • Govorestat, a CNS-penetrant Aldose Reductase Inhibitor, has received multiple regulatory designations including Orphan Drug status from both FDA and EMA for treating rare diseases including CMT-SORD.

Govorestat: FDA Approval Status and Its Role in Treating Galactosemia

5 months ago

Govorestat, developed by Applied Therapeutics, Inc., is a central nervous system penetrant Aldose Reductase Inhibitor aimed at treating galactosemia. Despite receiving Orphan Drug, Pediatric Rare Disease, and Fast Track designations, the FDA has not approved it, citing deficiencies in the clinical application.