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 (Nasdaq: APLT) will present virtually at the SVB Securities Global Biopharma Conference on February 16, 2023, at 2:20 p.m. ET. Interested parties can access the webcast via the Events page on the company's investor relations website, with a replay available afterward.
The company focuses on developing novel drug candidates targeting high unmet medical needs. Its lead candidate, AT-007, aims to treat CNS rare metabolic diseases, while AT-001 targets Diabetic Cardiomyopathy. Preclinical development includes AT-003 for Diabetic Retinopathy.
Applied Therapeutics (APLT) has partnered with Advanz Pharma to commercialize AT-007 in Europe for Galactosemia and SORD Deficiency. The deal includes milestone payments exceeding €130 million and a 20% royalty on future net sales. This partnership is expected to enhance Applied Therapeutics' capital position and extends its cash runway through critical milestones. Advanz will oversee the packaging and distribution, while Applied Therapeutics remains responsible for development and manufacturing.
Applied Therapeutics (NASDAQ: APLT) reported its Q3 2022 financial results, with significant advancements in its pipeline, including full enrollment in Phase 3 trials for AT-001 in Diabetic Cardiomyopathy and encouraging trends in the ACTION-Galactosemia Kids trial for AT-007. Cash and equivalents stood at $47.4 million, down from $80.8 million at year-end 2021. R&D expenses decreased to $13.1 million from $17.6 million year-over-year, while G&A expenses fell to $6.2 million from $10.8 million. The net loss narrowed to $19.1 million, or $0.40 per share, compared to a $28.4 million loss in Q3 2021.
Applied Therapeutics (Nasdaq: APLT) reported promising preclinical data supporting its investigational treatment, AT-001, for Diabetic Cardiomyopathy. Key findings show AT-001 effectively reduces cardiac fibrosis and prevents adverse remodeling. The ongoing Phase 3 ARISE-HF study emphasizes the importance of cardiac functional capacity, measured by Peak VO2, for patients' quality of life. This data will be presented at the American Heart Association Scientific Sessions from November 5-7, 2022, alongside additional insights into Diabetic Cardiomyopathy's diagnosis and prevalence.
Applied Therapeutics has announced the full enrollment of 675 patients in the Phase 3 ARISE-HF trial, evaluating AT-001 for treating Diabetic Cardiomyopathy (DbCM). This study, which is placebo-controlled and double-blinded, aims to measure cardiac functional capacity after 15 months. DbCM affects about 20% of Type 2 Diabetes patients, representing a substantial market opportunity. If successful, AT-001 could become the first approved treatment for DbCM. Topline data is expected by early 2024, with plans for additional long-term data collection.
Applied Therapeutics (APLT) announced that its Phase 3 ACTION-Galactosemia Kids trial for AT-007 (gavorostat) showed a trend towards clinical benefit compared to placebo, although statistical significance was not yet reached at 12 months. The company is meeting with the EMA to discuss conditional approval submission in the EU. Safety data indicates AT-007 is well tolerated, and the study will continue to 18 months for further evaluation. AT-007 targets Classic Galactosemia and has shown promise in reducing plasma galactitol levels in previous studies.
Applied Therapeutics, Inc. (NASDAQ: APLT) announced key developments in its second quarter financial results and ongoing clinical trials. The company completed a public equity offering, raising $30 million, and received orphan medicinal product designation from the EMA for AT-007 in treating Galactosemia. As of June 30, 2022, cash and equivalents totaled $67.7 million. While R&D expenses slightly increased to $15.4 million, G&A expenses decreased to $6.1 million. The company reported a net loss of $25.9 million, compared to the previous year's loss of $25.8 million.
Applied Therapeutics (Nasdaq: APLT) announced its sponsorship of the 2022 Galactosemia Foundation Conference, held July 28-30 in Orlando, Florida. The company is committed to the Galactosemia community, launching a new website and educational resources. Presentations at the conference will include updates on their clinical programs, particularly focusing on AT-007 for treating Galactosemia. The drug has shown significant efficacy in clinical trials, receiving FDA designations for its potential impact on patients suffering from this rare disorder.
Applied Therapeutics (NASDAQ: APLT) announced a public offering of 20 million shares of common stock and 10 million pre-funded warrants, aiming to raise approximately $30 million. Each share of common stock is priced at $1.00, while the pre-funded warrants are priced at $0.9999. Proceeds will be allocated for general corporate purposes, including R&D and clinical trials. The offering is set to close on June 27, 2022, pending customary conditions. The company is focusing on developing drug candidates for significant unmet medical needs, particularly in CNS rare metabolic diseases.
Applied Therapeutics (NASDAQ: APLT) announced a public offering of its common stock and pre-funded warrants, along with accompanying warrants. The company intends to use the net proceeds for general corporate purposes, including research and development costs and capital expenditures. SVB Securities is managing the offering, which is subject to market conditions. A registration statement has been filed for the offering, and no assurances can be made about its completion or final terms.