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 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.
The press release from Applied Therapeutics (Nasdaq: APLT) highlights significant progress in the ACTION-Galactosemia Kids study. The drug candidate AT-007 demonstrated a 40% reduction in plasma galactitol levels, statistically significant (p<0.001) compared to placebo, indicating potential to improve the quality of life for Galactosemia patients. Furthermore, higher baseline galactitol levels correlated with greater disease severity. The company plans to submit a New Drug Application to the FDA in Q4 2021 and is preparing for a potential product launch.
Applied Therapeutics (Nasdaq: APLT) announced significant progress in its pediatric ACTION-Galactosemia Kids study, showing a 35% reduction in plasma galactitol after 30 days of treatment with AT-007, meeting statistical significance (p<0.001) compared to placebo. The drug was well-tolerated among children aged 2-17. The company is adjusting dosing based on weight and plans to submit a New Drug Application to the FDA in Q4 2021. A baseline analysis revealed a correlation between plasma galactitol levels and disease severity in patients, marking a milestone in understanding Galactosemia.
Applied Therapeutics, Inc. (APLT) reported its Q2 2021 financial results, ending the quarter with $125.6 million in cash and equivalents. The company is preparing for a New Drug Application (NDA) submission for AT-007 in Galactosemia, expected in Q3 2021, and plans to launch commercially in 2022. R&D expenses decreased to $14.8 million, while G&A expenses rose to $11.1 million. The net loss for the quarter was $25.8 million, or $0.99 per share, an improvement from a $28.1 million loss in the same quarter last year.
Applied Therapeutics (Nasdaq: APLT) has officially joined the Russell Microcap® Index, effective June 25, 2021. This inclusion, lasting a year, provides automatic membership in related growth and value style indexes, which are crucial for institutional investors. The Russell indexes are benchmarked by approximately $10.6 trillion in assets, underscoring their market significance. Applied Therapeutics, focused on novel drug development for unmet medical needs, is progressing with its lead candidate, AT-007, among others.
Applied Therapeutics announced data confirming the high prevalence of Diabetic Cardiomyopathy (DbCM) among adults with diabetes or pre-diabetes, with studies showing about 17% prevalence in affected populations. The findings, presented at the 81st American Diabetes Association Scientific Sessions, highlight the urgent need for awareness and screening. The company is actively enrolling participants in its global ARISE-HF study for the investigational drug AT-001, targeting DbCM and its progression to overt heart failure.
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.
FAQ
What is the current stock price of Applied Therapeutics (APLT)?
What is the market cap of Applied Therapeutics (APLT)?
What is the primary focus of Applied Therapeutics, Inc.?
What is govorestat (AT-007)?
What are the recent achievements of Applied Therapeutics?
What other drugs are in the Applied Therapeutics pipeline?
How is govorestat expected to benefit patients with Galactosemia?
What recent financial activities has Applied Therapeutics undertaken?
What is the status of govorestat's regulatory review?
Where is Applied Therapeutics headquartered?
What are AT-001 and AT-003 intended to treat?
How can I learn more about Applied Therapeutics?
