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 (APLT) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Applied Therapeutics (APLT) Upgraded to Buy: Here's What You Should Know

Here is how Applied Therapeutics Inc. (APLT) and Axonics Modulation Technologies (AXNX) have performed compared to their sector so far this year.

Is Applied Therapeutics (APLT) Outperforming Other Medical Stocks This Year?

Here is how Applied Therapeutics Inc. (APLT) and CareCloud, Inc. (CCLD) have performed compared to their sector so far this year.

Are Medical Stocks Lagging Applied Therapeutics (APLT) This Year?

Here is how Applied Therapeutics Inc. (APLT) and Cardinal Health (CAH) have performed compared to their sector so far this year.

Is Applied Therapeutics (APLT) Stock Outpacing Its Medical Peers This Year?

All You Need to Know About Applied Therapeutics (APLT) Rating Upgrade to Buy

Applied Therapeutics stock surges 69% as the FDA says that no advisory committee meeting is required to discuss the govorestat NDA for classic galactosemia.

APLT Stock Soars 69% on Positive Update on Galactosemia Drug NDA

Applied Therapeutics, Inc.'s stock surged nearly 70% yesterday after the news that the FDA will not hold an AdCom to discuss approval of AT-007 in galactosemia. AT-007 has shown clinical benefits in galactosemia and SORD deficiency, and its PDUFA for the former arrives at the end of November. With no AdCom, approval seems the likeliest outcome. Despite financial constraints, strong patient and HCP support suggest a successful commercial launch for govorestat, making Applied stock a “Buy” with expected valuation growth.

Applied Therapeutics: AdCom Decision Takes Govorestat Approval A Step Closer

FDA removes the need for an advisory panel to first give a recommendation review of Applied Therapeutics, Inc.'s govorestat for the treatment of patients with galactosemia. PDUFA date of November 28th, 2024, remains on track for the FDA to decide whether govorestat should be approved to treat patients with galactosemia. Pre-NDA meeting with FDA expected in 2nd half of 2024 to discuss possible administrative actions of NDA filing submission of govorestat for the treatment of patients with SORD deficiency.

Applied Therapeutics: FDA Stance Change For Advisory Panel Bodes Well For Review

The FDA won't hold an Advisory Committee meeting to review Applied Therapeutics' regulatory filing for govorestat. This move could increase the likelihood that the drug will win FDA approval.

Why Applied Therapeutics Stock Is Skyrocketing Today

William Blair initiated coverage on Applied Therapeutics Inc. APLT, a late-stage development company focused on rare diseases such as galactosemia, SORD deficiency, and diabetic cardiomyopathy.

Rare Disease-Focused Applied Therapeutics' Lead Candidate Govorestat Has Blockbuster Potential, Analyst Sees 140% Stock Upside

NEW YORK, July 01, 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 Company was added to the Russell 3000® Index, effective after the U.S. market closed on June 28, 2024, as part of the 2024 Russell indexes annual reconstitution.

Applied Therapeutics Added to Russell 3000® Index

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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.

News for Applied Therapeutics Inc Stock (APLT)