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Applied Therapeutics Reports First Quarter 2024 Financial Results
09 mai 2024 07h00 HE | 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...
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Applied Therapeutics to Present at the 2024 RBC Capital Markets Global Healthcare Conference
07 mai 2024 07h00 HE | 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...
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Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer
15 avr. 2024 07h00 HE | 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...
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Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024
04 avr. 2024 07h00 HE | 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...
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Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
28 mars 2024 16h30 HE | 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...
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Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results
06 mars 2024 07h00 HE | 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...
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Applied Therapeutics Announces $100 Million Private Placement
28 févr. 2024 08h05 HE | Applied Therapeutics
Financing includes significant participation from a number of large healthcare dedicated institutional and mutual fund investors Net proceeds, along with existing cash and cash equivalents, are...
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Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia
28 févr. 2024 08h00 HE | Applied Therapeutics
PDUFA target action date of August 28, 2024 MAA validated and accepted for review by EMA in December 2023 NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a...
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Applied Therapeutics Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in Sorbitol Dehydrogenase (SORD) Deficiency
15 févr. 2024 07h00 HE | Applied Therapeutics
Interim primary endpoint met; Statistically significant correlation of sorbitol with the CMT-FOM clinical outcome composite (p=0.05) Sustained, statistically significant reduction in sorbitol in...
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Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy
04 janv. 2024 16h05 HE | Applied Therapeutics
AT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months AT-001 treatment resulted in a statistically significant...