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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Applied Therapeutics is a clinical-stage biotech focused on treating symptoms of galactosemia in the central nervous system. Govorestat (AT-007) is in late-stage regulatory approval for galactosemia, with a PDUFA date set for November 2024. APLT holds $146.5 million in cash, ensuring a sufficient runway to FDA approval and initial product revenues by early 2025.

Applied Therapeutics: A Strong Buy With AT-007 Nearing Approval For Galactosemia

NEW YORK, May 09, 2024 (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 reported financial results for the first quarter ended March 31, 2024.

Applied Therapeutics Reports First Quarter 2024 Financial Results

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 molecular targets in indications of high unmet medical need, today announced the appointment of Dale Hooks as Chief Commercial Officer, replacing Adam Hansard, effective immediately. Mr. Hooks joins Applied with over 30 years of biopharmaceutical experience in rare disease marketing and sales, holding various leadership roles. Mr. Hooks will be responsible for leading Applied's commercial preparations for the potential launch of govorestat for the treatment of Classic Galactosemia and SORD.

Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer

The U.S. Food and Drug Administration has extended its review of Applied Therapeutics' experimental drug to treat galactosemia, a rare genetic metabolic disease, the company said on Thursday.

US FDA extends review of Applied Therapeutics' genetic disease drug

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 molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia by three months. The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.

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

Applied Therapeutics (APLT) surges 124% in a month due to encouraging updates from two separate developmental programs for govorestat to treat different rare neurological indications.

Applied Therapeutics (APLT) Surges 124% in a Month: Here's Why

NEW YORK, March 06, 2024 (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 reported financial results for the fourth quarter and full year ended December 31, 2023.

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

Applied Therapeutics (NASDAQ: APLT ) stock is on the rise Wednesday after the clinical-stage biopharmaceutical company got an update from the Food and Drug Administration (FDA). The FDA has accepted the company's New Drug Application (NDA) for govorestat as a treatment for Classic Galactosemia.

Why Is Applied Therapeutics (APLT) Stock Up 59% Today?

Financing includes significant participation from a number of large healthcare dedicated institutional and mutual fund investors

Applied Therapeutics Announces $100 Million Private Placement

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 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 accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia. The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User Free Act (PDUFA) target action date of August 28, 2024.

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

Positive 12-month interim results from the phase 3 INSPIRE study using govorestat for the treatment of patients with SORD deficiency achieved. Pre-NDA meeting with FDA to be sought out after to see if an NDA submission of govorestat for SORD deficiency could be done with only the positive 12-month interim data. 24-month interim results from the phase 3 INSPIRE study, using govorestat for the treatment of patients with SORD deficiency, is the next data readout to be expected.

Applied Therapeutics: Speedy Regulatory Review Of Govorestat Might Be Possible

Applied Therapeutics shares plunged almost 35% after the biotechnology firm reported disappointing results from its Phase 3 heart disease trial. The company reported that its ARISE-HF trial of drug candidate AT-001 (caficrestat) in patients with diabetic cardiomyopathy (DbCM) at high risk of progressing to overt heart failure did not meet its primary endpoint of stabilization or improvement in cardiac functional capacity as measured by peak VO2.

Applied Therapeutics stock falters on heart disease trial failure

Applied Therapeutics (NASDAQ: APLT ) stock is falling on Friday following the release of Phase 3 clinical trial data from the clinical-stage biopharmaceutical company. This data comes from Applied Therapeutics' ARISE-HF Phase 3 trial of AT-001 in patients with Diabetic Cardiomyopathy who have a high risk of overt heart failure.

Why Is Applied Therapeutics (APLT) Stock Down 30% Today?

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

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