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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Demonstrated Long-term Clinical Benefit of Govorestat in ACTION-Galactosemia Kids Trial Strengthened Balance Sheet with $30 Million Private Placement of Equity Phase 3 INSPIRE Trial of Govorestat in Sorbitol Dehydrogenase (SORD) Deficiency and ARISE-HF Trial of AT-001 in Diabetic Cardiomyopathy on Track for Data in 2023 NEW YORK, May 11, 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 reported financial results for the first quarter ended March 31, 2023. “We are committed to bringing transformative therapies to patients with debilitating diseases and no treatment options, including Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.

Applied Therapeutics Reports First Quarter 2023 Financial Results

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NEW YORK, April 24, 2023 (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 announced it has entered into a definitive securities purchase agreement, dated as of April 23 2023, for the sale of 9,735,731 shares of the Company's common stock, par value $0.0001 per share at a purchase price of $0.946 per share (the “Shares”) and 22,000,000 pre-funded warrants to purchase common stock at a purchase price of $0.945, which equal the purchase price per share of common stock less the $0.001 per share exercise price of each pre-funded warrant (the “Pre-Funded Warrants” and together with the Shares the “Securities”), in a private placement (the “Private Placement”). The Private Placement was led by new investor Venrock Healthcare Capital Partners and is expected to result in gross proceeds to the Company of approximately $30 million, before deducting placement agent commissions and other offering expenses.

Applied Therapeutics, Inc. Announces $30 Million Private Placement of Equity

NEW YORK, April 24, 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 results from the ACTION-Galactosemia Kids study of govorestat (AT-007), a novel, oral, small molecule, central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI).

Applied Therapeutics Announces Clinical Benefit of Govorestat (AT-007) in ACTION-Galactosemia Kids Trial; Company Plans to Meet with FDA Regarding Potential NDA Submission

Progress in Three Phase 3 Trials in Areas of High Unmet Clinical Need, Including Positive Sorbitol Reduction Data from the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency

Applied Therapeutics Reports Fourth Quarter and Year-end 2022 Financial Results

NEW YORK, March 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 participate in a Neuromuscular & Bone Panel at the Cowen 43rd Annual Health Care Conference on Wednesday, March 8, 2023 at 2:10 p.m. ET in Boston.

Applied Therapeutics to Present at the Cowen 43rd Annual Health Care Conference

NEW YORK, Feb. 16, 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 positive sorbitol reduction data from the ongoing global Phase 3 INSPIRE trial. The INSPIRE trial is a Phase 3 double-blind placebo-controlled registrational study evaluating the effect of once-daily oral AT-007 in approximately 50 patients age 16-55 with SORD Deficiency in the US and Europe. SORD Deficiency (also called SORD Neuropathy or CMT-SORD) is a debilitating hereditary axonal neuropathy caused by mutations in the Sorbitol Dehydrogenase gene, leading to an inability to metabolize the sugar sorbitol, and resulting in accumulation of high levels of toxic sorbitol, which causes motor neuron degeneration and loss of mobility and motility. AT-007 (govorestat) is a central nervous system penetrant Aldose Reductase Inhibitor, which blocks conversion of glucose to sorbitol, and has previously been shown to reduce sorbitol levels in an open-label pilot study in patients with SORD Deficiency.

Applied Therapeutics Announces Positive Sorbitol Reduction Data From the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency

NEW YORK, Feb. 09, 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 present virtually at the SVB Securities Global Biopharma Conference on Thursday, February 16, 2023 at 2:20 p.m. ET.

Applied Therapeutics to Present at the SVB Securities Global Biopharma Conference

NEW YORK, Jan. 04, 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 a partnership with Advanz Pharma, a pharmaceutical company with a strategic focus on commercialization of specialty, hospital, and rare disease medicines, for commercialization of AT-007 (govorestat) in Europe.

Applied Therapeutics Announces Partnership with Advanz Pharma for Commercialization of AT-007 (Govorestat) in Europe

NEW YORK, Oct. 31, 2022 (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 data presentations at the upcoming American Heart Association Scientific Sessions, to be held November 5-7, 2022 in Chicago, IL. Data to be presented includes mechanistic support for AT-001 in a Diabetic Cardiomyopathy mouse model, demonstrating that AT-001 treatment prevents fibrosis and adverse cardiac remodeling; baseline data from the ongoing Phase 3 ARISE-HF study on quality of life impact of disease and correlation of cardiac functional capacity (peak VO2) with physical function; additional DbCM diagnosis and prevalence data.

Applied Therapeutics Announces Multiple Data Presentations at the American Heart Association Scientific Sessions November 5-7, 2022

NEW YORK, Oct. 25, 2022 (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 full enrollment in the Phase 3 registrational ARISE-HF trial, studying AT-001, a selective Aldose Reductase inhibitor, in patients with Diabetic Cardiomyopathy (DbCM).

Applied Therapeutics Announces Full Enrollment in the Registrational Phase 3 ARISE-HF Trial of AT-001 in Diabetic Cardiomyopathy

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• The study did not yet reach statistical significance at 12 months of treatment; however, AT-007 (gavorostat) demonstrated a trend in clinical benefit vs. placebo • Applied Therapeutics plans to meet with the EMA to discuss potential submission of the current data package for conditional approval in the EU • Trial will continue to 18 months in blinded format

Applied Therapeutics Announces Positive Data Trend in AT-007 ACTION-Galactosemia Kids Pediatric Trial; Trial Will Continue to 18 Months in Blinded Format

After losing some value lately, a hammer chart pattern has been formed for Applied Therapeutics Inc. (APLT), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.

Bears are Losing Control Over Applied Therapeutics Inc. (APLT), Here's Why It's a 'Buy' Now

Completed public equity offering with gross proceeds of $30 million

Applied Therapeutics Reports Second Quarter 2022 Financial Results

NEW YORK, June 22, 2022 (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 announced the pricing of its underwritten public offering of 20.0 million shares of its common stock, par value $0.0001 per share, 10.0 million pre-funded warrants to purchase common stock in lieu of common stock to certain investors, and accompanying warrants (“common warrants”) to purchase up to 30.0 million shares of its common stock. Each share of common stock and accompanying common warrant are being offered at a combined public offering price of $1.00, less underwriting discounts and commissions, and each pre-funded warrant and accompanying common warrant are being offered at a combined public offering price of $0.9999, less underwriting discounts and commissions. The pre-funded warrants have an exercise price of $0.0001 per share and the common warrants have an exercise price of $1.00 per share. The pre-funded warrants and the common warrants are immediately exercisable and will expire five years from the date of issuance. The gross proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by the Company, are expected to be $30 million.

Applied Therapeutics, Inc. Announces Pricing of $30 Million Public Offering of Common Stock and Warrants

NEW YORK, June 22, 2022 (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 announced that it plans to make a public offering of shares of its common stock, par value $0.0001 per share, or pre-funded warrants to purchase common stock in lieu of common stock to certain investors, and accompanying warrants to purchase shares of its common stock, in an underwritten registered public offering.

Applied Therapeutics, Inc. Announces Public Offering of Common Stock and Warrants

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NEW YORK, June 03, 2022 (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 designation of AT-007 (gavorestat) as an orphan medicinal product by the European Medicines Agency (EMA) for treatment of Galactosemia (Galactosaemia).

Applied Therapeutics Receives Orphan Medicinal Product Designation from the EMA for AT-007 for Treatment of Galactosemia

NEW YORK, May 19, 2022 (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 participate in a fireside chat at the UBS Global Healthcare Conference on Wednesday, March 25, 2022 at 10:45 a.m. ET in New York.

Applied Therapeutics to Present at the UBS Global Healthcare Conference

News for Applied Therapeutics Inc Stock (APLT)