Applied Therapeutics Stock Price, News & Analysis

Applied Therapeutics, Inc. (Nasdaq: APLT) reported financial results for Q3 2021, highlighting significant advancements in its AT-007 drug for SORD deficiency and Galactosemia. In a pilot trial, AT-007 reduced blood sorbitol levels by approximately 66%. The ACTION-Galactosemia Kids study showed a statistical 40% reduction in plasma galactitol. The company ended Q3 with $108.8 million in cash. However, the net loss for the quarter was $28.4 million, or $1.09 per share, a slight improvement from the $29.8 million loss a year prior.

Applied Therapeutics (Nasdaq: APLT) announced promising results from a pilot trial of AT-007 for SORD Deficiency, a rare neurological disorder. AT-007 decreased blood sorbitol levels by approximately 66% in patients, with a range of 54%-75% reduction. The drug was safe and well tolerated. The company plans to initiate a registrational trial by the end of 2021. With around 3,300 patients in the US affected by this condition, AT-007 could be a first disease-modifying therapy. The company is also enhancing patient screening and diagnosis.

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.