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May 09, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Reports First Quarter 2024 Financial Results

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...
May 07, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics to Present at the 2024 RBC Capital Markets Global Healthcare Conference

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...
April 15, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer

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...
April 04, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024

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...
March 28, 2024 16:30 ET | Source: Applied Therapeutics

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

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...
March 06, 2024 07:00 ET | Source: Applied Therapeutics

Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results

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...
February 28, 2024 08:05 ET | Source: Applied Therapeutics

Applied Therapeutics Announces $100 Million Private Placement

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...
February 28, 2024 08:00 ET | Source: Applied Therapeutics

Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia

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...
February 15, 2024 07:00 ET | Source: Applied Therapeutics

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

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...
January 04, 2024 16:05 ET | Source: Applied Therapeutics

Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy

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...