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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AT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months

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

EMA validated and accepted the regulatory application of govorestat for the treatment of patients with galactosemia; the FDA has a 60-day review period to look at the application for validation and acceptance. Release of results from the phase 3 ARISE-HF study, using AT-001 for the treatment of patients with cardiomyopathy, is expected any day now in Q1 of 2024. Release of results from the phase 3 INSPIRE study, using AT-007 for the treatment of patients with SORD Deficiency, expected Q1 of 2024.

Applied Therapeutics: Multiple Inflection Points Could Generate Substantial Value

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Regulatory submissions on track for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA in 4Q 2023

Applied Therapeutics Reports Third Quarter 2023 Financial Results

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 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 will host a Diabetic Cardiomyopathy (DbCM) expert forum with key opinion leaders on Tuesday, November 7, 2023 at 8:00 a.m. ET. Members of the Company's senior management team will be joined by the following key opinion leaders: James Januzzi, MD, Hutter Family Professor of Medicine, Harvard Medical School; Director, Dennis and Marilyn Barry Fellowship in Cardiology Research, Massachusetts General Hospital Gregory Lewis, MD, Director, Cardiopulmonary Exercise Testing Laboratory and Section Head, Heart Failure, Massachusetts General Hospital The agenda for the event is as follows: Diabetic Cardiomyopathy Disease Overview & Treatment Landscape (Dr. Januzzi) ARISE-HF Registrational Phase 3 Trial Overview (Dr. Januzzi) Cardiac Functional Capacity (primary endpoint in ARISE-HF) (Dr. Lewis) Q&A (with Drs.

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

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 exhibit reduced cardiac functional capacity resulting in decreased physical activity NEW YORK, Sept. 28, 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 unmet medical need, today announced it will participate in a Symposium presentation, entitled Diabetic Cardiomyopathy (DbCM): a severe complication of diabetes, at the 59th European Association for the Study of Diabetes (EASD) Annual Meeting to take place October 2-6, 2023 in Hamburg, Germany and online.

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

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 unmet medical need, today announced successful completion of a recent pre-New Drug Application (“NDA”) meeting with the Food and Drug Administration (FDA) regarding its govorestat (AT-007) Galactosemia program. Based on discussions with the FDA, the Company believes they are aligned with the FDA and plans to submit an NDA for govorestat (AT-007) for the treatment of Galactosemia in the fourth quarter of this 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

Applied Therapeutics is a micro-cap with low cash balance, but has major upcoming catalysts (pre-NDA meeting for galactosemia and phase 3 results in diabetic cardiomyopathy) and a huge upside potential. Despite missing the primary endpoint in galactosemia ph3 trial, APLT still plans for NDA submission. The pre-NDA meeting with the FDA this summer will be a big catalyst if positive. I expect a positive outcome from the meeting considering consistent and meaningful clinical benefit in multiple endpoints, orphan and fast-track designation, no alternative treatments, and the significant burden for affected patients.

Applied Therapeutics: Buy For Upcoming Pre-NDA Meeting (I Expect A Positive Outcome)

Regulatory progress for govorestat (AT-007) for the treatment of Classic Galactosemia, with potential NDA submission based on discussions with the FDA as well as EMA Marketing Authorization Application planned in Fall 2023

Applied Therapeutics Reports Second Quarter 2023 Financial Results

NEW YORK , June 27, 2023 /PRNewswire/ -- Levi & Korsinsky announces that it has commenced an investigation of Applied Therapeutics, Inc. (NASDAQ: APLT) concerning possible breaches of fiduciary duty. To obtain additional information, go to: https://zlk.com/compensation2/applied-therapeutics-inc-information-request-form-2 or contact Joseph E.

SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of an Investigation Concerning Possible Breaches of Fiduciary Duty by Certain Officers and Directors of Applied Therapeutics, Inc. (NASDAQ: APLT)

NEW YORK , June 27, 2023 /PRNewswire/ -- Purcell & Lefkowitz LLP, a class action law firm dedicated to representing shareholders nationwide, is investigating a potential breach of fiduciary duty claim involving the board of directors of Applied Therapeutics, Inc. (NASDAQ: APLT). If you are a shareholder of Applied Therapeutics, Inc. and are interested in obtaining additional information regarding this investigation, free of charge, please visit us at: https://pjlfirm.com/applied-therapeutics-inc/ You may also contact Robert H.

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Is Investigating Applied Therapeutics, Inc. for Potential Breaches of Fiduciary Duty By Its Board of Directors

NEW YORK, June 22, 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 unmet medical need, today announced multiple presentations on AT-001 (caficrestat) and the ARISE-HF Phase 3 study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association to take place June 23 - 26 in San Diego, California.

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

NEW YORK, May 25, 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 unmet medical need, today announced that AT-007 (govorestat) has been granted orphan medicinal product designation by the European Medicines Agency (EMA) for treatment of Sorbitol Dehydrogenase (SORD) Deficiency. Additionally, the Company announced that new data has been published in the Journal of Clinical Investigation on govorestat treatment in models of SORD Deficiency.

Govorestat (AT-007) Receives Orphan Medicinal Product Designation from the EMA for Treatment of SORD Deficiency

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 Dehydrogenase (SORD) Deficiency and ARISE-HF Trial of AT-001 in Diabetic Cardiomyopathy on Track for Data in 2023 NEW YORK, May 11, 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 unmet medical need, today reported financial results for the first quarter ended March 31, 2023. “We are committed to bringing transformative therapies to patients with debilitating diseases and no treatment options, including Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.

Applied Therapeutics Reports First Quarter 2023 Financial Results

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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 indications of high unmet medical need, today announced it has entered into a definitive securities purchase agreement, dated as of April 23 2023, for the sale of 9,735,731 shares of the Company's common stock, par value $0.0001 per share at a purchase price of $0.946 per share (the “Shares”) and 22,000,000 pre-funded warrants to purchase common stock at a purchase price of $0.945, which equal the purchase price per share of common stock less the $0.001 per share exercise price of each pre-funded warrant (the “Pre-Funded Warrants” and together with the Shares the “Securities”), in a private placement (the “Private Placement”). The Private Placement was led by new investor Venrock Healthcare Capital Partners and is expected to result in gross proceeds to the Company of approximately $30 million, before deducting placement agent commissions and other offering expenses.

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

NEW YORK, April 24, 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 unmet medical need, today announced results from the ACTION-Galactosemia Kids study of govorestat (AT-007), a novel, oral, small molecule, central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI).

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

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

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

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 unmet medical need, today announced that it will participate in a Neuromuscular & Bone Panel at the Cowen 43rd Annual Health Care Conference on Wednesday, March 8, 2023 at 2:10 p.m. ET in Boston.

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

NEW YORK, Feb. 16, 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 unmet medical need, today announced positive sorbitol reduction data from the ongoing global Phase 3 INSPIRE trial. The INSPIRE trial is a Phase 3 double-blind placebo-controlled registrational study evaluating the effect of once-daily oral AT-007 in approximately 50 patients age 16-55 with SORD Deficiency in the US and Europe. SORD Deficiency (also called SORD Neuropathy or CMT-SORD) is a debilitating hereditary axonal neuropathy caused by mutations in the Sorbitol Dehydrogenase gene, leading to an inability to metabolize the sugar sorbitol, and resulting in accumulation of high levels of toxic sorbitol, which causes motor neuron degeneration and loss of mobility and motility. AT-007 (govorestat) is a central nervous system penetrant Aldose Reductase Inhibitor, which blocks conversion of glucose to sorbitol, and has previously been shown to reduce sorbitol levels in an open-label pilot study in patients with SORD Deficiency.

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

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 unmet medical need, today announced that it will present virtually at the SVB Securities Global Biopharma Conference on Thursday, February 16, 2023 at 2:20 p.m. ET.

Applied Therapeutics to Present at the SVB Securities Global Biopharma Conference

NEW YORK, Jan. 04, 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 unmet medical need, today announced a partnership with Advanz Pharma, a pharmaceutical company with a strategic focus on commercialization of specialty, hospital, and rare disease medicines, for commercialization of AT-007 (govorestat) in Europe.

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

NEW YORK, Oct. 31, 2022 (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 multiple data presentations at the upcoming American Heart Association Scientific Sessions, to be held November 5-7, 2022 in Chicago, IL. Data to be presented includes mechanistic support for AT-001 in a Diabetic Cardiomyopathy mouse model, demonstrating that AT-001 treatment prevents fibrosis and adverse cardiac remodeling; baseline data from the ongoing Phase 3 ARISE-HF study on quality of life impact of disease and correlation of cardiac functional capacity (peak VO2) with physical function; additional DbCM diagnosis and prevalence data.

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