Welcome to our dedicated page for Applied Therapeutics news (Ticker: APLT), a resource for investors and traders seeking the latest updates and insights on Applied Therapeutics stock.
Applied Therapeutics, Inc. (Nasdaq: APLT) is a clinical-stage biopharmaceutical company that regularly issues news about its progress in developing novel drug candidates for rare diseases. The company’s updates frequently focus on its lead drug candidate, govorestat (AT-007), a central nervous system penetrant Aldose Reductase Inhibitor (ARI) being developed for CNS rare metabolic diseases such as Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD), and phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG).
On this APLT news page, readers can find company press releases covering clinical trial milestones, including detailed data from the INSPIRE Phase 2/3 and registrational Phase 3 trial of govorestat in CMT-SORD, investigator-initiated studies in PMM2-CDG, and regulatory interactions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These items often describe safety findings, sorbitol reduction, functional and patient-reported outcomes, and plans for potential New Drug Application (NDA) strategies.
News items also report on regulatory designations for govorestat, such as Orphan Drug, Orphan Medicinal Product, Rare Pediatric Disease, and Fast Track designations, as well as corporate developments like leadership appointments, workforce changes, cost-containment measures, and business development activities. Examples include the out-licensing of AT-001 for diabetic cardiomyopathy and partnership arrangements related to the company’s pipeline.
Another key category of APLT news involves strategic and capital markets events. Applied Therapeutics has announced a strategic review process, at-the-market equity offering agreements, Nasdaq listing and bid price notices, and, most notably, an Agreement and Plan of Merger with Cycle Group Holdings Limited. Updates related to the planned tender offer, contingent value rights (CVR) structure, and expected acquisition timeline are central topics for investors following APLT.
By reviewing the Applied Therapeutics news feed, investors and observers can track how the company describes its clinical, regulatory, financial, and strategic developments over time, and how these developments relate to the evolution of APLT stock and the proposed acquisition by Cycle.
Applied Therapeutics, a clinical-stage biopharmaceutical company (Nasdaq: APLT), will showcase two poster presentations on AT-001 at the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 23, 2020. AT-001 is a next-generation aldose reductase inhibitor in Phase 3 development for Diabetic Cardiomyopathy. Presentations will highlight its safety, specificity, and protection against cellular damage due to hyperglycemia. Chief Medical Officer Riccardo Perfetti emphasizes AT-001's improved clinical safety profile and target selectivity.
Applied Therapeutics, Inc. (Nasdaq: APLT) announced its participation in two notable investor conferences in September 2020. The first is Citi's 15th Annual BioPharma Virtual Conference on September 9, 2020, from 4:15 to 5:00 p.m. ET, followed by the Baird 2020 Global Healthcare Conference on September 10, 2020, from 2:35 to 3:05 p.m. ET. Webcast details will be available on the company's website, and a replay will follow. Applied Therapeutics focuses on developing treatments for high unmet medical needs, notably its lead candidate AT-007 for Galactosemia.
Applied Therapeutics (APLT) announced its Q2 2020 financial results, reflecting a net loss of $28.1 million, or $1.27 per share, up from $8.4 million, or $0.60 per share, in Q2 2019. Cash reserves were reported at $138.5 million, down from $154.3 million in Q1 2020. R&D expenses surged to $20.8 million as the company advanced its AT-007 and AT-001 programs. The general and administrative costs increased to $7.5 million, driven by headcount growth and professional fees. The company remains committed to its drug development pipeline targeting unmet medical needs.
Applied Therapeutics (Nasdaq: APLT) presented updates on AT-007, its oral treatment for Galactosemia, during the Galactosemia Foundation 2020 Virtual Conference from July 17-19. CEO Shoshana Shendelman emphasized the importance of collaboration with the Galactosemia community. Key presentations included:
- AT-007: Development of an Oral Treatment - July 18, 10:00 AM ET
- ACTION-Galactosemia: Clinical Experience - July 18, 4:15 PM ET
- ACTION-Galactosemia Kids Study - July 18, 5:30 PM ET
Slides will be available post-conference on the company's website.
Applied Therapeutics has responded to a fraudulent short report posted on July 1, 2020, which contains manipulated data intended to mislead investors and manipulate its stock price. The company is collaborating with law enforcement and has engaged legal counsel to address this criminal activity. Despite these challenges, Applied Therapeutics reaffirms its commitment to delivering innovative drug candidates, highlighting its focus on high unmet medical needs, including treatments for Galactosemia and Diabetic Cardiomyopathy.
Applied Therapeutics (Nasdaq: APLT) announced that three abstracts, including one oral presentation, have been selected for the American Diabetes Association’s 80th Scientific Sessions from June 12-16, 2020. The presentations focus on the investigational candidate AT-001 for Diabetic Cardiomyopathy (DbCM), a next-generation aldose reductase inhibitor. Chief Medical Officer Riccardo Perfetti highlighted advancements in safety and efficacy over previous ARIs, showcasing improved data on AT-001 compared to zopolrestat. Presentations will be available from June 9, 2020.
Applied Therapeutics (Nasdaq: APLT) announced its participation at the UBS Global Healthcare Conference, scheduled for May 18, 2020, at 10:00 a.m. ET in a virtual format. The event will be accessible via a webcast on the company’s website, with a replay available afterward.
The company specializes in developing novel drug candidates for high unmet medical needs, including AT-007 for Galactosemia and AT-001 for Diabetic Cardiomyopathy. Their preclinical pipeline includes AT-003 for diabetic retinopathy and dual PI3k inhibitors for oncology.