Applied Therapeutics

Yahoo Finance • last year

Applied Therapeutics Reports Third Quarter 2023 Financial Results

Regulatory submissions on track for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA in 4Q 2023 Two Upcoming Phase 3 Trial Readouts, with ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy on... Full story

Yahoo Finance • last year

Applied Therapeutics to Present at the UBS Biopharma Conference 2023

NEW YORK, Nov. 02, 2023 (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 u... Full story

Yahoo Finance • last year

Applied Therapeutics to Host Diabetic Cardiomyopathy Expert Forum with Key Opinion Leaders on Tuesday, November 7

Forum to be Webcast Live Topline Phase 3 Data Readout from ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy On Track for 4Q 2023 NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a... Full story

Yahoo Finance • last year

Applied Therapeutics to Present Baseline Data from Phase 3 ARISE-HF Study Evaluating AT-001 at the 2023 EASD Annual Meeting

The ongoing ARISE-HF Phase 3 global clinical trial is evaluating the efficacy of AT-001 (caficrestat) on cardiac functional capacity in patients with diabetic cardiomyopathy (DbCM)Baseline data from ARISE-HF shows patients with DbCM exhibi... Full story

Yahoo Finance • last year

Applied Therapeutics Announces Successful Pre-NDA Meeting with the FDA and Confirms Plans to Submit NDA for Govorestat (AT-007) for Treatment of Classic Galactosemia to FDA in Q4 2023

NEW YORK, Sept. 06, 2023 (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... Full story

Yahoo Finance • last year

Applied Therapeutics to Present Baseline Data on the Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association

The ongoing ARISE-HF Phase 3 global clinical trial is evaluating the safety and efficacy of AT-001 (caficrestat) in improving or preventing worsening of cardiac functional capacity in Diabetic Cardiomyopathy (DbCM); topline data from the s... Full story

Yahoo Finance • last year

Applied Therapeutics to Present Data on AT-007 (Govorestat) Treatment in SORD Deficiency at the 2023 Annual Meeting of the Peripheral Nerve Society

Data further elucidates the pathophysiology of sorbitol toxicity, including sorbitol accumulation as the driver of disease in patient-derived motor neurons, as well as in the drosophila model and a new rat model of SORD Deficiency Clinical... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Reports First Quarter 2023 Financial Results

Applied Therapeutics Demonstrated Long-term Clinical Benefit of Govorestat in ACTION-Galactosemia Kids Trial Strengthened Balance Sheet with $30 Million Private Placement of Equity Phase 3 INSPIRE Trial of Govorestat in Sorbitol Dehydro... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Announces Clinical Benefit of Govorestat (AT-007) in ACTION-Galactosemia Kids Trial; Company Plans to Meet with FDA Regarding Potential NDA Submission

Govorestat demonstrated consistent long-term clinical outcomes benefit across a range of functional measures in the ACTION-Galactosemia Kids trial, confirming prior biomarker dataGovorestat treatment improved activities of daily living, be... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics, Inc. Announces $30 Million Private Placement of Equity

NEW YORK, April 24, 2023 (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 indi... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Reports Fourth Quarter and Year-end 2022 Financial Results

Progress in Three Phase 3 Trials in Areas of High Unmet Clinical Need, Including Positive Sorbitol Reduction Data from the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency On Track to Report Additional Phase 3 Dat... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics to Present at the Cowen 43rd Annual Health Care Conference

NEW YORK, March 01, 2023 (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... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Announces Positive Sorbitol Reduction Data From the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency

The ongoing Phase 3 INSPIRE trial is evaluating the effect of AT-007 vs. placebo in patients with SORD Deficiency on sorbitol reduction as well as clinical outcomes in approximately 50 patients age 16-55 in the US and EuropeAT-007 reduced... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics to Present at the SVB Securities Global Biopharma Conference

NEW YORK, Feb. 09, 2023 (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 u... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Announces Partnership with Advanz Pharma for Commercialization of AT-007 (Govorestat) in Europe

Advanz Pharma will leverage its specialty, hospital, and rare disease expertise and infrastructure to commercialize AT-007 in Europe for both Galactosemia and SORD DeficiencyApplied Therapeutics will receive milestone payments of over €130... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Reports Third Quarter 2022 Financial Results

NEW YORK, Nov. 09, 2022 (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 indic... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Announces Multiple Data Presentations at the American Heart Association Scientific Sessions November 5-7, 2022

Additional preclinical data supports AT-001 as an effective treatment for Diabetic Cardiomyopathy, reducing cardiac fibrosis and adverse remodelingBaseline analysis of Phase 3 ARISE-HF study supports the primary endpoint (cardiac functiona... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Announces Full Enrollment in the Registrational Phase 3 ARISE-HF Trial of AT-001 in Diabetic Cardiomyopathy

ARISE-HF is a global registrational study in 675 patients with Diabetic Cardiomyopathy (DbCM), evaluating the potential of AT-001 to improve or prevent worsening of cardiac function vs. placeboPrimary study endpoint is cardiac functional c... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics Reports Second Quarter 2022 Financial Results

Completed public equity offering with gross proceeds of $30 million Granted orphan medicinal product designation by the EMA for AT-007 for treatment of Galactosemia Continued progress in three registrational Phase 3 trials in areas of hi... Full story

Yahoo Finance • 2 years ago

Applied Therapeutics, Inc. Announces Pricing of $30 Million Public Offering of Common Stock and Warrants

NEW YORK, June 22, 2022 (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 indic... Full story