– Appointed John H. Johnson as Executive Chairman; Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer; and Reena Thomas Colacot as Vice President and Head of Quality NEW YORK, April 14, 2025 (GLOBE NEWSWIRE) — Applied Therapeutics, In…
NEW YORK, March 31, 2025 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high…
Dr. Baumgartner will advance Applied’s preparation for upcoming regulatory interactions NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments …
Ms. Colacot brings over 25 years of quality leadership experience across the biopharmaceutical and medical device industries NEW YORK, Jan. 21, 2025 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to…
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, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to c…
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 that the U.S. Food and Drug Administration (FDA) has is…
– 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 – NDA submission for govorestat for the treatment of SORD D…
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 molecular targets in indications of high unmet medical ne…
– 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 November 28, 2024 NEW YORK, Sept. 18, 2024 (GLOBE NEW…
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 molecular targets in indications of high unmet medical n…
