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Applied Therapeutics Inc - APLT STOCK NEWS

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

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Applied Therapeutics's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Applied Therapeutics's position in the market.

News
Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.94%
Tags
management
-
News
Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-4.67%
Tags
conferences clinical trial
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News
Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-6.91%
Tags
none
News
Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
4.7%
Tags
earnings
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News
Applied Therapeutics Announces $100 Million Private Placement
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
32.62%
Tags
none
-
News
Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
32.62%
Tags
clinical trial
News
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
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
39.93%
Tags
clinical trial
-
News
Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-40.63%
Tags
clinical trial
-
News
Applied Therapeutics Announces MAA Validation and NDA Submission of Govorestat (AT-007) for Treatment of Classic Galactosemia
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.37%
Tags
none
News
Applied Therapeutics Reports Third Quarter 2023 Financial Results
Rhea-AI Summary
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.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-10.39%
Tags
earnings
Stock APLT logo
Applied Therapeutics Inc

Nasdaq:APLT

APLT Rankings

#3009 Ranked by Market Cap
#26 Ranked by Stock Gains
N/A Ranked by Dividends

APLT Stock Data

545.32M
84.90M
6.9%
69.56%
4.7%
Research and Development in Biotechnology
Professional, Scientific, and Technical Services
Link
US
New York

About APLT

applied therapeutics, inc. is a hospital and health care company located in 3104 cherry palm dr, tampa, fl, united states.