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Applied Therapeutics, Inc. (Nasdaq: APLT) is a clinical-stage biopharmaceutical company headquartered at 3104 Cherry Palm Dr, Tampa, FL. The company focuses on creating novel drug candidates targeting validated molecular markers for diseases with high unmet medical needs.
Currently, the company has several promising compounds in its pipeline. The lead candidate is govorestat (AT-007), a central nervous system penetrant Aldose Reductase Inhibitor (ARI) designed to treat rare metabolic diseases like Classic Galactosemia, SORD Deficiency, and PMM2-CDG. Govorestat has shown significant clinical benefits in reducing toxic metabolites like galactitol and sorbitol, leading to improvements in activities of daily living, cognitive skills, and motor functions in both adult and pediatric patients.
In recent achievements, Applied Therapeutics has completed Phase 3 trials for govorestat in treating Classic Galactosemia and SORD Deficiency, receiving Priority Review status for its New Drug Application (NDA) from the U.S. FDA. The company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). Additionally, Applied Therapeutics is preparing for the commercial launch of govorestat upon potential approval by regulatory authorities.
Other key pipeline candidates include AT-001 for Diabetic Cardiomyopathy (DbCM) and AT-003 for Diabetic Retinopathy. AT-001 has shown favorable results in stabilizing cardiac functional capacity in patients with DbCM and is safe and well-tolerated. AT-003, still in preclinical development, is designed to address diabetic retinopathy.
Financially, Applied Therapeutics reported strong progress, raising $100 million in a private placement to extend its cash runway into 2026. This funding supports its clinical and commercial activities, ensuring sustained growth and development.
To learn more about Applied Therapeutics, visit their official website at www.appliedtherapeutics.com and follow them on Twitter @Applied_Tx.
Applied Therapeutics (Nasdaq: APLT) announced pre-clinical data showing that AT-001, an Aldose Reductase inhibitor, normalizes cardiac energetics and improves cardiac function in a mouse model of Diabetic Cardiomyopathy (DbCM). AT-001 treatment led to decreased cardiac fatty acid oxidation rates and improved cardiac efficiency. This promising data supports the ongoing Phase 3 ARISE-HF study targeting patients at high risk for heart failure. The findings indicate AT-001's potential to shift cardiac cells towards a non-diabetic state, offering meaningful implications for DbCM patients.
Applied Therapeutics (Nasdaq: APLT) announced its participation in the ASHG 2020 Annual Meeting, where it will present two significant posters on AT-007, targeting Galactosemia. The presentations will showcase both animal model efficacy data and adult clinical safety and biomarker efficacy results. Chief Medical Officer Riccardo Perfetti highlighted that preclinical data shows AT-007 reduces galactitol levels, potentially preventing CNS complications. The posters will be presented on October 26, 2020, including insights from the ACTION-Galactosemia study.
Applied Therapeutics (Nasdaq: APLT) announced that the FDA has granted both Pediatric Rare Disease and Orphan Drug Designations for its drug candidate AT-007, aimed at treating PMM2-CDG, a severe rare disease with no current approved therapies. PMM2-CDG leads to multiple organ failure and has about 20% mortality in early childhood. AT-007, a CNS penetrant Aldose Reductase inhibitor, has shown biological activity in relevant models. The company plans to begin a clinical study in 2021, working closely with experts and the FDA to develop a comprehensive clinical program.
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.
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