Articles from Applied Therapeutics

Ms. Colacot brings over 25 years of quality leadership experience across the biopharmaceutical and medical device industries

Shoshana Shendelman Steps Down as CEO; Les Funtleyder Appointed Interim Chief Executive Officer

NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia.

- NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in Q1 2025

NEW YORK, Nov. 05, 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 it will present at the 2024 UBS Global Healthcare Conference on Tuesday, November 12, 2024, at 7:15 a.m. PT in Rancho Palos Verdes, California.

- Company completed Late-Cycle review meeting with FDA

NEW YORK, Sept. 04, 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 will participate in the following upcoming investor conferences:

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.

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.

NEW YORK, May 07, 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 it will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024 at 4:35 p.m. ET in New York, New York.

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.

NEW YORK, April 04, 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 it will present full results from the Phase 3 ARISE-HF study evaluating AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM) in an oral presentation at the 2024 American College of Cardiology (ACC) Annual Scientific Session to take place April 6-8, 2024 in Atlanta, Georgia.

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.

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.

Financing includes significant participation from a number of large healthcare dedicated institutional and mutual fund investors

PDUFA target action date of August 28, 2024

Interim primary endpoint met; Statistically significant correlation of sorbitol with the CMT-FOM clinical outcome composite (p=0.05)

AT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months

NDA submitted to FDA and MAA validated by EMA in December 2023

Regulatory submissions on track for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA in 4Q 2023

NEW YORK, Nov. 02, 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 at the UBS Biopharma Conference 2023 on Thursday, November 9, 2023 at 2:00 p.m. ET in Miami, Florida.

Forum to be Webcast Live

NEW YORK, Sept. 06, 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 successful completion of a recent pre-New Drug Application (“NDA”) meeting with the Food and Drug Administration (FDA) regarding its govorestat (AT-007) Galactosemia program. Based on discussions with the FDA, the Company believes they are aligned with the FDA and plans to submit an NDA for govorestat (AT-007) for the treatment of Galactosemia in the fourth quarter of this year.

Regulatory progress for govorestat (AT-007) for the treatment of Classic Galactosemia, with potential NDA submission based on discussions with the FDA as well as EMA Marketing Authorization Application planned in Fall 2023

Pre-NDA Meeting to be held with FDA this summer to discuss potential NDA submission for govorestat (AT-007) for treatment of Classic Galactosemia

NEW YORK, June 22, 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 multiple presentations on AT-001 (caficrestat) and the ARISE-HF Phase 3 study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association to take place June 23 - 26 in San Diego, California.

NEW YORK, June 15, 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 multiple oral presentations at the 2023 Annual Meeting of the Peripheral Nerve Society to take place June 17 - 20 in Copenhagen, Denmark.

NEW YORK, May 25, 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 AT-007 (govorestat) has been granted orphan medicinal product designation by the European Medicines Agency (EMA) for treatment of Sorbitol Dehydrogenase (SORD) Deficiency. Additionally, the Company announced that new data has been published in the Journal of Clinical Investigation on govorestat treatment in models of SORD Deficiency.

Demonstrated Long-term Clinical Benefit of Govorestat in ACTION-Galactosemia Kids Trial

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).

NEW YORK, April 24, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQAPLT) (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.

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

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.

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.

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.

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.

NEW YORK, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQAPLT) (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 third quarter ended September 30, 2022.

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.

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).

• 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

NEW YORK, July 28, 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 its sponsorship and presentations at the 2022 Galactosemia Foundation Conference being held July 28-30 in Orlando, Florida.