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Applied Therapeutics, Inc. - APLT STOCK NEWS

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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.

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Applied Therapeutics (Nasdaq: APLT) announced the acceptance of their abstract #OP005 for an oral presentation at the 2022 Annual Clinical Genetics Meeting, scheduled for March 22-26 in Nashville. This presentation will focus on the efficacy of AT-007 in reducing toxic galactitol levels in pediatric patients with Classic Galactosemia. Dr. Riccardo Perfetti highlighted the significant correlation between galactitol levels and CNS deficit severity in patients. Approximately 3,000 individuals are affected by Galactosemia in the U.S., emphasizing the importance of ongoing clinical research and development.

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Applied Therapeutics, Inc. (Nasdaq: APLT) reported its fourth-quarter and full-year financial results for 2021, showing a net loss of $105.6 million, or $4.12 per share, up from a loss of $94.0 million in 2020. The company is focused on three ongoing Phase 3 trials in Galactosemia, SORD Deficiency, and Diabetic Cardiomyopathy. A regulatory update indicates the FDA may require clinical outcomes data for the Galactosemia program before NDA submission. Cash reserves are reported at $80.8 million, down from $96.8 million in 2020, while R&D expenses increased to $62.6 million.

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Applied Therapeutics, Inc. (Nasdaq: APLT) has announced its participation in two key investor conferences in March 2022. The Cowen 42nd Annual Health Care Conference will be held on March 7, 2022, with a panel discussion scheduled from 9:10 to 10:10 a.m. ET. The Barclays Global Healthcare Conference is set for March 17, 2022, featuring a presentation from 10:15 to 10:40 a.m. ET. Interested investors can access the webcast on the company's Investor Relations page and listen to replays afterward. The company focuses on developing treatments for unmet medical needs.

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Applied Therapeutics (Nasdaq: APLT) is marking the 15th Annual Rare Disease Day to enhance awareness of rare diseases, specifically focusing on Galactosemia and SORD Deficiency. The company is actively supporting events like the GLOW for Galactosemia in Knoxville, Tennessee, and collaborating with advocacy partners on various initiatives. Its lead drug candidate, AT-007, aims to treat rare metabolic diseases with a high unmet medical need. The company emphasizes its commitment to developing solutions for these conditions, aligning with its clinical-stage development goals.

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Applied Therapeutics, a clinical-stage biopharmaceutical company (Nasdaq: APLT), will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 11:20 a.m. ET. The event's webcast can be accessed via the company's Investor Relations page. Applied Therapeutics focuses on developing novel drug candidates for high unmet medical needs, notably with three Phase 3 programs in progress, including lead drug AT-007 for rare CNS diseases and AT-001 for Diabetic Cardiomyopathy.

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Applied Therapeutics (Nasdaq: APLT) announced a regulatory update on its AT-007 Galactosemia program. Following discussions with the FDA, the company will delay submitting an NDA for AT-007, as clinical outcomes data will now likely be required for approval. The ongoing Phase 3 ACTION-Galactosemia Kids study assesses AT-007's impact on clinical outcomes, with the first assessment due in Q1 2022. Despite the disappointment, CEO Shoshana Shendelman expressed commitment to work with the FDA on the approval process.

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Applied Therapeutics has launched a registrational phase 2/3 study of AT-007 targeting Sorbitol Dehydrogenase (SORD) Deficiency, a hereditary neuropathy affecting around 3,300 patients in the U.S. and 4,000 in Europe. The INSPIRE trial aims to evaluate the safety and efficacy of AT-007 compared to placebo, focusing on sorbitol reduction and clinical outcomes. Initial data from a pilot study showed a 66% reduction in blood sorbitol levels. This milestone could offer new hope for patients suffering from this debilitating condition.

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Applied Therapeutics (Nasdaq: APLT) announced its participation in the 14th International Congress of Inborn Errors of Metabolism (ICIEM) from November 21-23, 2021, in Sydney, Australia. The company's CEO, Shoshana Shendelman, highlighted critical data correlating toxic galactitol levels with disease severity in Galactosemia. Key presentations include studies on the impact of Galactosemia on children and adults, and an upcoming symposium on targeting toxic galactitol for treatment. The company develops therapies for rare metabolic diseases and has notable candidates like AT-007 for Galactosemia.

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Applied Therapeutics, Inc. (Nasdaq: APLT) reported financial results for Q3 2021, highlighting significant advancements in its AT-007 drug for SORD deficiency and Galactosemia. In a pilot trial, AT-007 reduced blood sorbitol levels by approximately 66%. The ACTION-Galactosemia Kids study showed a statistical 40% reduction in plasma galactitol. The company ended Q3 with $108.8 million in cash. However, the net loss for the quarter was $28.4 million, or $1.09 per share, a slight improvement from the $29.8 million loss a year prior.

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Applied Therapeutics (Nasdaq: APLT) announced promising results from a pilot trial of AT-007 for SORD Deficiency, a rare neurological disorder. AT-007 decreased blood sorbitol levels by approximately 66% in patients, with a range of 54%-75% reduction. The drug was safe and well tolerated. The company plans to initiate a registrational trial by the end of 2021. With around 3,300 patients in the US affected by this condition, AT-007 could be a first disease-modifying therapy. The company is also enhancing patient screening and diagnosis.

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FAQ

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

The current stock price of Applied Therapeutics (APLT) is $0.8516 as of December 24, 2024.

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

The market cap of Applied Therapeutics (APLT) is approximately 99.1M.

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.

Applied Therapeutics, Inc.

Nasdaq:APLT

APLT Rankings

APLT Stock Data

99.09M
102.11M
5.24%
101.91%
11.66%
Biotechnology
Pharmaceutical Preparations
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United States of America
NEW YORK