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Govorestat (AT-007)

Classic Galactosemia

Phase 3Regulatory Strategy Phase

Key Facts

Indication
Classic Galactosemia
Phase
Phase 3
Status
Regulatory Strategy Phase
Company

About Applied Therapeutics

Applied Therapeutics (Nasdaq: APLT) is a clinical-stage biotech founded in 2016 with a mission to develop transformative therapies for rare diseases by targeting well-validated molecular pathways. Its core achievement is the advancement of govorestat, a novel Aldose Reductase Inhibitor, into Phase 3 development for Classic Galactosemia and SORD Deficiency, utilizing biomarker-driven trial designs aligned with new FDA guidance. The company's strategic focus on regulatory acceleration and validated biology is poised for a significant inflection point, bolstered by a pending acquisition by Cycle Pharmaceuticals Group which aims to provide the capital and operational expertise needed to bring these critical therapies to market.

View full company profile

About Applied Therapeutics

Applied Therapeutics (Nasdaq: APLT) is a clinical-stage biotech founded in 2016 with a mission to develop transformative therapies for rare diseases by targeting well-validated molecular pathways. Its core achievement is the advancement of govorestat, a novel Aldose Reductase Inhibitor, into Phase 3 development for Classic Galactosemia and SORD Deficiency, utilizing biomarker-driven trial designs aligned with new FDA guidance. The company's strategic focus on regulatory acceleration and validated biology is poised for a significant inflection point, bolstered by a pending acquisition by Cycle Pharmaceuticals Group which aims to provide the capital and operational expertise needed to bring these critical therapies to market.

View full company profile

About Applied Therapeutics

Applied Therapeutics (Nasdaq: APLT) is a clinical-stage biotech founded in 2016 with a mission to develop transformative therapies for rare diseases by targeting well-validated molecular pathways. Its core achievement is the advancement of govorestat, a novel Aldose Reductase Inhibitor, into Phase 3 development for Classic Galactosemia and SORD Deficiency, utilizing biomarker-driven trial designs aligned with new FDA guidance. The company's strategic focus on regulatory acceleration and validated biology is poised for a significant inflection point, bolstered by a pending acquisition by Cycle Pharmaceuticals Group which aims to provide the capital and operational expertise needed to bring these critical therapies to market.

View full company profile