Applied Therapeutics Inc

Applied Therapeutics, Inc. is a clinical-stage biopharmaceutical company which engages in the development of a pipeline of novel products. It is targeting treatments for central nervous system rare diseases and diabetic complications. The company was founded by Shoshana Shendelman on January 20, 2016 and is headquartered in New York, NY.

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NEW YORK, June 28, 2021 (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 need, today announced that the Company has joined the Russell Microcap® Index. The newly reconstituted index took effect after the market close on Friday, June 25, 2021.

Applied Therapeutics Added to Russell Microcap® Index

~1 in 5 people with diabetes or pre-diabetes have Diabetic Cardiomyopathy, a serious and progressive disease that limits the heart's ability to function   People with diabetes or pre-diabetes who have Diabetic Cardiomyopathy are at high risk for developing overt heart failure

Applied Therapeutics Announces Presentation of Data on the Prevalence of Diabetic Cardiomyopathy at the 81st Scientific Sessions of the 2021 Annual Meeting of the American Diabetes Association

NEW YORK, June 21, 2021 (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 need, today announced a Product Theater presentation at the upcoming 81st Scientific Sessions of the annual 2021 American Diabetes Association meeting taking place virtually June 25-29. The Product Theater will include an overview of Diabetic Cardiomyopathy (DbCM), the increased risk of progression to overt heart failure and death due to the disease, new data on the wide prevalence of the disease among patients with diabetes, the role of aldose reductase in the pathogenesis of disease, and a review of the ongoing ARISE-HF global registrational trial of AT-001, a novel and selective aldose reductase inhibitor.

Applied Therapeutics to Present on Diabetic Cardiomyopathy and Prevalence of Disease at the 81st Scientific Sessions of the 2021 Annual Meeting of the American Diabetes Association

The FDA has granted Fast Track designation to Applied Therapeutics Inc's (NASDAQ: APLT) AT-007 to treat Galactosemia, a rare metabolic disease. AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders.

Applied Therapeutics Stock Moves Higher On FDA Fast Track Review For AT-007 In Rare Metabolic Disorder

NEW YORK, June 17, 2021 (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 need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AT-007 for the treatment of Galactosemia, a rare metabolic disease. AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders, including Galactosemia, SORD and PMM2-CDG.

Applied Therapeutics Granted Fast Track Designation by FDA for AT-007 for Galactosemia

NEW YORK, June 01, 2021 (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 need, announced today that it will present at the Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 at 1:20 p.m. ET.

Applied Therapeutics to Present at the Goldman Sachs 42nd Annual Global Healthcare Conference

NEW YORK, May 19, 2021 (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 need, announced today that it will present at the UBS Global Healthcare Virtual Conference on Tuesday, May 25, 2021 at 10:00 a.m. ET.

Applied Therapeutics to Present at the UBS Global Healthcare Virtual Conference

Phase 2 pilot study of AT-007 initiated in patients with SORD Deficiency

Applied Therapeutics Reports First Quarter 2021 Financial Results

AT-007 ACTION-Galactosemia Kids pediatric clinical study recently resumed following discussions with FDA

Applied Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results

NEW YORK, Feb. 23, 2021 (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 need, announced today that it will present at two upcoming investor conferences in March:

Applied Therapeutics to Present at the Cowen and Barclays Investor Conferences

NEW YORK, Feb. 22, 2021 (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 unmet medical need, today announced the closing of its public offering of 3,000,000 shares of its common stock, par value $0.0001 per share.  The shares were offered at a price to the public of $23.00 per share, resulting in aggregate net proceeds of approximately $64.6 million, after deducting underwriting discounts and commissions and estimated offering expenses.  The offering closed on February 17, 2021.  The Company granted the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock at the price to the public, less underwriting discounts and commissions, which the underwriters exercised in full on February 17, 2021 and settled on February 19, 2021.

Applied Therapeutics, Inc. Announces Closing of Public Offering

Applied Therapeutics Inc (NASDAQ: APLT) prices its underwritten public offering of 3 million at $23 per share, raising $69 million in gross proceeds, at a marginal premium of 2%. Underwriters have an option to purchase up to 450,000 additional shares.

Applied Therapeutics Raises $69M Via Equity

NEW YORK, Feb. 11, 2021 (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 unmet medical need, today announced the pricing of its underwritten public offering of 3,000,000 shares of its common stock, par value $0.0001 per share, at a price to the public of $23.00 per share. The gross proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, are expected to be $69 million. The Company has granted the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock at the price to the public, less underwriting discounts and commissions.

Applied Therapeutics, Inc. Announces Pricing of Public Offering of 3,000,000 Shares of Common Stock

NEW YORK, Feb. 10, 2021 (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 unmet medical need, today announced that it plans to make a public offering of 3,000,000 shares of its common stock, par value $0.0001 per share, in an underwritten registered public offering. The Company expects to grant the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock.

Applied Therapeutics, Inc. Announces Offering of 3,000,000 Shares of Common Stock

Applied Therapeutics Announces Restart of Pediatric Galactosemia Study

NEW YORK, Dec. 09, 2020 (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 need, today announced the launch of Galactosemia Together, the first and only industry-led Galactosemia awareness and education campaign. Developed in partnership with the Galactosemia community, this initiative aims to address gaps in education by providing updated, reliable and credible resources to help connect, educate and support those families impacted by this disease.

Applied Therapeutics Announces Launch of Galactosemia Awareness and Education Initiative

NEW YORK, Dec. 09, 2020 (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 need, today announced magnetic resonance spectroscopy (MRS) data on reduction of galactitol levels in the brain of Galactosemia patients treated with AT-007 in the ACTION-Galactodsemia adult study. Overall, plasma reduction in galactitol correlated with brain reduction in galactitol. There were two exceptions, which may have resulted from incomplete peak separation on the MRS scans. At the two doses which demonstrated statistically significant reduction in plasma galactitol, 20 and 40mg/kg, 3 out of 4 patients displayed substantial galactitol reduction ranging from 61.94% to 69.80% reduction from baseline.

Applied Therapeutics Announces MRS Data from ACTION-Galactosemia Study

Continued enrollment in the ARISE-HF Phase 3 global registrational study of AT-001 in Diabetic Cardiomyopathy (fatal heart disease affecting ~17% diabetics)

Applied Therapeutics Reports Third Quarter 2020 Financial Results

Treatment with AT-001 normalizes cardiac energetics and improves cardiac function in a mouse model of Diabetic Cardiomyopathy (DbCM) Treatment with AT-001 normalizes cardiac energetics and improves cardiac function in a mouse model of Diabetic Cardiomyopathy (DbCM)

Applied Therapeutics Announces Presentation of Pre-Clinical Data on AT-001 for the Treatment of Diabetic Cardiomyopathy at the American Heart Association (AHA) Scientific Sessions 2020

NEW YORK, Oct. 21, 2020 (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 need, announced today that it will present two poster presentations covering AT-007 in Galactosemia at the upcoming American Society of Human Genetics (ASHG) 2020 Annual Meeting. The presentations include animal model efficacy data and adult clinical data on the safety and biomarker efficacy of Applied Therapeutics' investigational candidate for Galactosemia, AT-007, a Central Nervous System (CNS) penetrant Aldose Reductase Inhibitor (ARI).

Applied Therapeutics to Present Data on AT-007 for the Treatment of Galactosemia at the American Society of Human Genetics (ASHG) 2020 Annual Meeting

Applied Therapeutics Inc. (APLT) closed at $22.86 in the latest trading session, marking a -0.95% move from the prior day.

Applied Therapeutics Inc. (APLT) Stock Sinks As Market Gains: What You Should Know

Applied Therapeutics Inc. (NASDAQ: APLT) shares pushed higher on Thursday after a new analyst report came out supposing massive upside for this biotech.

Could Applied Therapeutics Stock Rise 300%?

Applied Therapeutics Inc. (APLT) closed at $20.02 in the latest trading session, marking a +0.05% move from the prior day.

Applied Therapeutics Inc. (APLT) Gains As Market Dips: What You Should Know

NEW YORK, Sept.  24, 2020  (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 need, announced today that the U.S. Food and Drug Administration (FDA) has granted AT-007 both Pediatric Rare Disease Designation and Orphan Drug Designation for treatment of PMM2-CDG. PMM2-CDG is a debilitating rare disease caused by deficiency in the critical enzyme phosphomannomutase-2, required for systemic glycosylation of proteins. PMM2-CDG causes multiple organ failure and severe disability, resulting in approximately 20% mortality in the first four years of life.   There are currently no drugs approved to treat PMM2-CDG.

FDA Grants AT-007 Pediatric Rare Disease Designation and Orphan Designation for Treatment of PMM2-CDG

NEW YORK, Sept.  17, 2020  (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 need, announced today that it will present two poster presentations covering AT-001, a next generation aldose reductase inhibitor (ARI), in Phase 3 development for Diabetic Cardiomyopathy at the upcoming 56th Annual Meeting of the European Association for the Study of Diabetes (EASD). The presentations include data on the safety and specificity of AT-001, as well as data on mechanistic protection from cellular damage during hyperglycemia.

Applied Therapeutics to Present Data on AT-001 for Treatment of Diabetic Cardiomyopathy at 56th Annual Meeting of the European Association for the Study of Diabetes

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