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Mar 31, 2024
Applied Therapeutics Q1 2024 Earnings Report
Reported financial results for the first quarter ended March 31, 2024.
Key Takeaways
Applied Therapeutics reported its first quarter 2024 financial results, highlighting preparations for the potential approval and commercial launch of govorestat for Classic Galactosemia in the US and EU. The company is also in discussions regarding a potential NDA submission for SORD Deficiency with the FDA.
Preparing for potential approval and commercial launch of govorestat for Classic Galactosemia in the US and EU.
Govorestat NDA for Classic Galactosemia under Priority Review with a PDUFA target action date of November 28, 2024.
Govorestat MAA under review by EMA; decision expected in early Q1 2025.
Discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with the Neurology I Division of FDA.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
The company expects its cash and cash equivalents will fund the business into 2026.