Applied Therapeutics Stock Price, News & Analysis

Applied Therapeutics (Nasdaq: APLT) announced its selection for the NASDAQ Biotechnology Index effective December 21, 2020. This index tracks biotechnology and pharmaceutical securities on NASDAQ, with companies meeting specific market value and volume criteria. Applied Therapeutics focuses on developing novel drug candidates for unmet medical needs, including its lead candidate AT-007 for Galactosemia. The addition to the index may enhance visibility and attract investment due to the index's association with notable ETFs like the iShares NASDAQ Biotechnology ETF.

Applied Therapeutics (Nasdaq: APLT) has launched the "Galactosemia Together" campaign, marking the first industry-led initiative aimed at raising awareness and educating the public about Galactosemia. This campaign, developed with the Galactosemia community, aims to provide reliable resources for families affected by the disease. Galactosemia is a rare genetic metabolic disorder affecting approximately 3,000 individuals in the U.S. The company is also advancing its lead drug candidate, AT-007, for Galactosemia treatment, alongside other drug candidates for different metabolic conditions.

Applied Therapeutics (Nasdaq: APLT) announced promising magnetic resonance spectroscopy (MRS) data from its ACTION-Galactosemia study, showing significant reductions in galactitol levels in the brains of Galactosemia patients treated with AT-007. Patients receiving 20 and 40 mg/kg doses experienced a 61.94% to 69.80% reduction in plasma galactitol. Chief Medical Officer Riccardo Perfetti highlighted this as a significant advancement in Galactosemia research. A conference call is scheduled to discuss the findings in detail.

Applied Therapeutics (Nasdaq: APLT) continues to advance its pipeline in the third quarter of 2020, focusing on Diabetic Cardiomyopathy with robust enrollment in the ARISE-HF Phase 3 study. The company also plans to initiate rare disease programs for SORD Deficiency and PMM2-CDG in 2021. Financially, APLT reported a net loss of $29.8 million, up from $10.7 million in the same quarter last year, with research and development expenses increasing significantly to $19.9 million. Cash reserves stood at $116.5 million as of September 30, 2020, indicating a strong financial position for ongoing projects.

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.