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March 19, 2025 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Appoints Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer

NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced...
January 21, 2025 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Appoints Reena Thomas Colacot as Vice President and Head of Quality

NEW YORK, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced...
December 20, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Appoints John H. Johnson as Executive Chairman

Shoshana Shendelman Steps Down as CEO; Les Funtleyder Appointed Interim Chief Executive Officer Announces Business Updates NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics,...
November 27, 2024 16:10 ET | Source: Applied Therapeutics

Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia

NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced...
November 07, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Reports Third Quarter 2024 Financial Results

- NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in Q1 2025 -...
November 05, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics to Present at the 2024 UBS Global Healthcare Conference

NEW YORK, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...
September 18, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic Galactosemia

- Company completed Late-Cycle review meeting with FDA - FDA no longer intends to hold Advisory Committee meeting - FDA Review of NDA continues to proceed as planned with PDUFA target action date of...
September 04, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics to Participate in Upcoming Investor Conferences

NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...
August 07, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Reports Second Quarter 2024 Financial Results

NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in early Q1...
July 01, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Added to Russell 3000® Index

NEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...