Applied Therapeutics Stock Price, News & Analysis

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.

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.