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Sep 30, 2024
Applied Therapeutics Q3 2024 Earnings Report
Reported financial results for the third quarter ended September 30, 2024.
Key Takeaways
Applied Therapeutics reported financial results for Q3 2024, highlighting progress in regulatory submissions for govorestat in Classic Galactosemia and SORD Deficiency. The company is preparing for commercialization, with NDA review ongoing for Classic Galactosemia and NDA submission expected for SORD Deficiency in early Q1 2025. Cash and cash equivalents totaled $98.9 million. Net loss for the quarter was $68.6 million.
NDA review of govorestat for Classic Galactosemia is ongoing with a PDUFA target action date of November 28, 2024; MAA is under CHMP review by the EMA with a decision expected in Q1 2025.
NDA submission for govorestat for SORD Deficiency under Accelerated Approval is anticipated in early Q1 2025.
The company presented clinical data and development characterization of govorestat for Classic Galactosemia at medical conferences.
Cash and cash equivalents and short-term investments totaled $98.9 million as of September 30, 2024.
Forward Guidance
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” “predicts” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements.
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