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, Inc. (Nasdaq: APLT) announced a Product Theater presentation at the 81st Scientific Sessions of the American Diabetes Association, occurring virtually from June 25-29, 2021. The presentation, titled "Diabetic Cardiomyopathy – An Opportunity for Clinical Intervention," will discuss the prevalence of Diabetic Cardiomyopathy (DbCM) and its link to heart failure risks. Presenters include Dr. Jim Januzzi and Dr. Riccardo Perfetti. The ongoing ARISE-HF trial of AT-001, an aldose reductase inhibitor for DbCM, will also be reviewed. Data highlights the critical need for monitoring DbCM in diabetic patients.
Applied Therapeutics (Nasdaq: APLT) received FDA Fast Track designation for its drug AT-007, aimed at treating Galactosemia, a rare metabolic disorder. This designation will expedite the drug's development and review process, allowing early patient access. AT-007, a central nervous system-penetrant Aldose Reductase inhibitor, demonstrated positive results in clinical trials by reducing toxic levels of galactitol. The company plans to submit a New Drug Application (NDA) for Accelerated Approval in Q3 2021, having already received Orphan Drug and Pediatric Rare Disease status from the FDA.
Applied Therapeutics (Nasdaq: APLT) announced its participation in the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021, at 1:20 p.m. ET. The event will be available via a webcast on the company's website, with a replay following the live session.
The company is known for developing novel drug candidates targeting significant medical needs, including its lead candidate, AT-007, for Galactosemia and AT-001 for Diabetic Cardiomyopathy.
Applied Therapeutics (Nasdaq: APLT), a clinical-stage biopharmaceutical company, will present at the UBS Global Healthcare Virtual Conference on May 25, 2021, at 10:00 a.m. ET. Investors can access the webcast on their website, with a replay available afterward.
The company is focused on developing drug candidates for high unmet medical needs, including AT-007 for Galactosemia and AT-001 for Diabetic Cardiomyopathy. Their clinical trials seek to address critical health issues in rare diseases.
Applied Therapeutics (APLT) reported its Q1 2021 financial results, ending the quarter with $148.1 million in cash and cash equivalents. The company continues to develop therapies for high unmet medical needs, including AT-007 for Galactosemia and SORD Deficiency. A Phase 2 pilot study of AT-007 has commenced, and a New Drug Application (NDA) submission for Galactosemia is anticipated by Q3 2021. However, the company reported a net loss of $24.2 million, or $1.00 per share, increasing from a loss of $12.4 million in Q1 2020.
Applied Therapeutics (Nasdaq: APLT) announced a poster presentation at the 2021 Annual Clinical Genetics Meeting of ACMG, held from April 13-16. The presentation focuses on the progressive worsening of the central nervous system phenotype in children with Classic Galactosemia. Riccardo Perfetti, Chief Medical Officer, stated the urgency for disease-modifying therapies based on the findings. The poster, titled 'Progressive Worsening of CNS Phenotype in Children with Classic Galactosemia', will be accessible on the ACMG website.
Applied Therapeutics (APLT) recently announced important developments including the resumption of the AT-007 ACTION-Galactosemia Kids pediatric clinical study, with a New Drug Application (NDA) submission targeted for Q3 2021.
The company also successfully closed a public offering, raising approximately $74.3 million, enhancing its cash position to $96.8 million. Additionally, research and development expenses surged to $61.8 million, reflecting increased clinical activities. However, the net loss for 2020 widened to $94.0 million, indicating growing financial challenges.
Applied Therapeutics (Nasdaq: APLT) announces a Virtual Rare Disease Forum on March 23, 2021, from 1:00pm to 3:00pm ET to showcase its drug development programs for Galactosemia, SORD Deficiency, and PMM2-CDG. Key updates will include insights on the ACTION-Galactosemia program and updates on SORD and PMM2-CDG clinical development plans. The event aims to highlight the potential of its lead candidate AT-007 in addressing rare diseases. An audio webcast will be available live, with details found on their official website.
Applied Therapeutics, Inc. (Nasdaq: APLT) announced its participation in two investor conferences in March 2021. The first is the Cowen 41st Annual Health Care Conference on March 2, 2021, from 9:10 to 9:40 a.m. ET. The second is the Barclays Global Healthcare Conference scheduled for March 9, 2021, from 4:45 to 5:10 p.m. ET. The webcasts will be available on their website's Investor Relations section, with a replay option post-event. Applied Therapeutics develops novel drug candidates targeting high unmet medical needs, including treatments for rare diseases.
Applied Therapeutics (NASDAQ: APLT) has completed a public offering of 3,000,000 shares at $23.00 each, raising approximately $64.6 million net of expenses. The offering closed on February 17, 2021, with underwriters exercising an option for an additional 450,000 shares. The funds will be utilized to advance clinical and preclinical development of its drug candidates and general corporate purposes. The offering was managed by Goldman Sachs & Co. LLC, Cowen, and UBS Investment Bank.