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Applied Therapeutics, Inc. - APLT STOCK NEWS

Welcome to our dedicated page for Applied Therapeutics news (Ticker: APLT), a resource for investors and traders seeking the latest updates and insights on Applied Therapeutics stock.

Applied Therapeutics, Inc. (Nasdaq: APLT) is a clinical-stage biopharmaceutical company headquartered at 3104 Cherry Palm Dr, Tampa, FL. The company focuses on creating novel drug candidates targeting validated molecular markers for diseases with high unmet medical needs.

Currently, the company has several promising compounds in its pipeline. The lead candidate is govorestat (AT-007), a central nervous system penetrant Aldose Reductase Inhibitor (ARI) designed to treat rare metabolic diseases like Classic Galactosemia, SORD Deficiency, and PMM2-CDG. Govorestat has shown significant clinical benefits in reducing toxic metabolites like galactitol and sorbitol, leading to improvements in activities of daily living, cognitive skills, and motor functions in both adult and pediatric patients.

In recent achievements, Applied Therapeutics has completed Phase 3 trials for govorestat in treating Classic Galactosemia and SORD Deficiency, receiving Priority Review status for its New Drug Application (NDA) from the U.S. FDA. The company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). Additionally, Applied Therapeutics is preparing for the commercial launch of govorestat upon potential approval by regulatory authorities.

Other key pipeline candidates include AT-001 for Diabetic Cardiomyopathy (DbCM) and AT-003 for Diabetic Retinopathy. AT-001 has shown favorable results in stabilizing cardiac functional capacity in patients with DbCM and is safe and well-tolerated. AT-003, still in preclinical development, is designed to address diabetic retinopathy.

Financially, Applied Therapeutics reported strong progress, raising $100 million in a private placement to extend its cash runway into 2026. This funding supports its clinical and commercial activities, ensuring sustained growth and development.

To learn more about Applied Therapeutics, visit their official website at www.appliedtherapeutics.com and follow them on Twitter @Applied_Tx.

News

Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer

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Applied Therapeutics appoints Dale Hooks as Chief Commercial Officer, bringing over 30 years of biopharmaceutical experience to lead commercial preparations for the potential launch of govorestat for Classic Galactosemia and SORD. Hooks has a proven track record in rare disease marketing and sales, overseeing 20+ new product launches and leading commercial operations at Reata Pharmaceuticals and Genentech.
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Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024

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Applied Therapeutics, Inc. (Nasdaq: APLT) announced the presentation of full results from the Phase 3 ARISE-HF study evaluating AT-001 in Diabetic Cardiomyopathy at the 2024 ACC Annual Scientific Session. The study showed a significant difference in cardiac functional capacity and prevented progression to overt heart failure compared to placebo.
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Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

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Applied Therapeutics, Inc. (Nasdaq: APLT) announces FDA extension for govorestat NDA for Classic Galactosemia treatment, with new PDUFA target date of November 28, 2024. Govorestat shows promise in reducing galactitol levels and improving clinical outcomes. FDA requested additional time for review due to supplemental analyses. Company remains confident in approval potential.
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Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results

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Applied Therapeutics, Inc. (Nasdaq: APLT) reported significant clinical and regulatory progress with the NDA acceptance and MAA validation for govorestat for the treatment of Galactosemia. Positive results from the 12-month interim analysis of govorestat in the INSPIRE Phase 3 trial in SORD Deficiency were also announced. The company strengthened its balance sheet with a $100 million Private Placement, extending its cash runway into 2026.
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Applied Therapeutics Announces $100 Million Private Placement

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Applied Therapeutics, Inc. secures $100 million in equity financing through a private placement, extending cash runway into 2026. The financing involves large healthcare institutional and mutual fund investors, including Perceptive Advisors and Janus Henderson Investors.
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Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia

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Applied Therapeutics, Inc. announces FDA acceptance of NDA for govorestat (AT-007) for Classic Galactosemia treatment with Priority Review status and PDUFA target action date of August 28, 2024. The FDA plans an advisory committee meeting. The drug has received various designations and is supported by positive clinical outcomes data.
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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

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Applied Therapeutics, Inc. (Nasdaq: APLT) announces positive interim 12-month results from the Phase 3 INSPIRE trial for govorestat in SORD Deficiency. The trial met primary and key secondary endpoints, showing statistically significant reduction in sorbitol levels and improvement in patient-reported outcomes. The company plans to request a pre-NDA meeting with the FDA and aims to bring a potential treatment option to patients soon.
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Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy

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Applied Therapeutics, Inc. (Nasdaq: APLT) announced the topline results of the ARISE-HF Phase 3 trial of AT-001 (caficrestat) in patients with Diabetic Cardiomyopathy (DbCM). The trial demonstrated a strong trend in stabilizing cardiac functional capacity, favorable safety and tolerability profile, and a potential tool for physicians in treating DbCM patients.
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Applied Therapeutics Announces MAA Validation and NDA Submission of Govorestat (AT-007) for Treatment of Classic Galactosemia

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Applied Therapeutics, Inc. (Nasdaq: APLT) submits NDA to FDA and MAA to EMA for govorestat (AT-007) for the treatment of Classic Galactosemia based on positive results from Phase 3 ACTION-Galactosemia Kids study. The submissions include clinical outcomes data from pediatric and adult patients, with the FDA and EMA review processes underway.
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Applied Therapeutics Reports Third Quarter 2023 Financial Results

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APLT - Applied Therapeutics, Inc. reports 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, ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy and INSPIRE Trial of AT-007 trial in Sorbitol Dehydrogenase (SORD) Deficiency on track for data readout in 4Q 2023 and 1Q 2024, respectively. Financial results for the third quarter ended September 30, 2023, show cash and cash equivalents totaling $37.5 million and a net loss of $42.4 million.
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FAQ

What is the current stock price of Applied Therapeutics (APLT)?

The current stock price of Applied Therapeutics (APLT) is $0.8667 as of December 23, 2024.

What is the market cap of Applied Therapeutics (APLT)?

The market cap of Applied Therapeutics (APLT) is approximately 95.2M.

What is the primary focus of Applied Therapeutics, Inc.?

Applied Therapeutics focuses on developing novel drug candidates against validated molecular targets for diseases with high unmet medical needs.

What is govorestat (AT-007)?

Govorestat is a CNS penetrant Aldose Reductase Inhibitor developed for treating rare metabolic diseases like Classic Galactosemia, SORD Deficiency, and PMM2-CDG.

What are the recent achievements of Applied Therapeutics?

Recent achievements include completing Phase 3 trials for govorestat, obtaining FDA Priority Review status for its NDA, and submitting an MAA to the EMA.

What other drugs are in the Applied Therapeutics pipeline?

The pipeline includes AT-001 for Diabetic Cardiomyopathy and AT-003 for Diabetic Retinopathy.

How is govorestat expected to benefit patients with Galactosemia?

Govorestat reduces plasma galactitol levels, improving activities of daily living, cognitive skills, and motor functions in patients with Galactosemia.

What recent financial activities has Applied Therapeutics undertaken?

Applied Therapeutics raised $100 million in a private placement to extend its cash runway into 2026, supporting clinical and commercial activities.

What is the status of govorestat's regulatory review?

Govorestat's NDA is under Priority Review by the FDA with a PDUFA target action date of November 28, 2024. Its MAA is under review by the EMA.

Where is Applied Therapeutics headquartered?

Applied Therapeutics is headquartered at 3104 Cherry Palm Dr, Tampa, FL, United States.

What are AT-001 and AT-003 intended to treat?

AT-001 is developed for Diabetic Cardiomyopathy, and AT-003 is intended for the treatment of Diabetic Retinopathy.

How can I learn more about Applied Therapeutics?

You can learn more by visiting their website at www.appliedtherapeutics.com and following them on Twitter @Applied_Tx.

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Applied Therapeutics, Inc.

Nasdaq:APLT

APLT Rankings

#4440 Ranked by Market Cap
N/A Ranked by Dividends

APLT Stock Data

95.25M
102.26M
5.24%
101.91%
11.66%
Biotechnology
Pharmaceutical Preparations
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United States of America
NEW YORK