Applied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic Galactosemia
18 sept. 2024 07h00 HE
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Applied Therapeutics
- 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...
Applied Therapeutics to Participate in Upcoming Investor Conferences
04 sept. 2024 07h00 HE
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Applied Therapeutics
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...
Applied Therapeutics Reports Second Quarter 2024 Financial Results
07 août 2024 07h00 HE
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Applied Therapeutics
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...
Applied Therapeutics Added to Russell 3000® Index
01 juil. 2024 07h00 HE
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Applied Therapeutics
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...
Applied Therapeutics Reports First Quarter 2024 Financial Results
09 mai 2024 07h00 HE
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Applied Therapeutics
Govorestat NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024 Govorestat MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision...
Applied Therapeutics to Present at the 2024 RBC Capital Markets Global Healthcare Conference
07 mai 2024 07h00 HE
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Applied Therapeutics
NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...
Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer
15 avr. 2024 07h00 HE
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Applied Therapeutics
NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...
Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024
04 avr. 2024 07h00 HE
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Applied Therapeutics
NEW YORK, April 04, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...
Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
28 mars 2024 16h30 HE
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Applied Therapeutics
NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...
Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results
06 mars 2024 07h00 HE
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Applied Therapeutics
NDA for govorestat accepted and granted Priority Review by FDA for the treatment of Classic Galactosemia; PDUFA target action date of August 28, 2024; MAA under review by EMA with decision expected in...