Applied Therapeutics Stock Price, News & Analysis

Applied Therapeutics, Inc. (Nasdaq: APLT) announced findings at the 2022 Annual Meeting of the Peripheral Nerve Society regarding SORD Deficiency. Data revealed that high levels of sorbitol correlate with disease severity. In a pilot study, treatment with AT-007 significantly reduced sorbitol levels, which are linked to mitochondrial dysfunction and neuronal loss. The findings indicate AT-007 could prevent disease progression by inhibiting sorbitol production. This research highlights the potential of AT-007, a novel Aldose Reductase inhibitor, in treating SORD Deficiency.

Applied Therapeutics (Nasdaq: APLT) announced poster presentations at the 43rd Annual Meeting of the Society for Inherited Metabolic Disorders, held April 10-13, 2022, in Orlando, Florida. The presentations highlighted baseline data from the ACTION-Galactosemia Kids study, revealing significant disease burdens in pediatric patients with Galactosemia, including neurological issues due to elevated galactitol levels. The drug candidate AT-007, designed for treating Galactosemia, is undergoing a Phase 3 clinical trial, showcasing its potential in reducing toxic levels and disease complications.

Applied Therapeutics (Nasdaq: APLT) announced the acceptance of their abstract #OP005 for an oral presentation at the 2022 Annual Clinical Genetics Meeting, scheduled for March 22-26 in Nashville. This presentation will focus on the efficacy of AT-007 in reducing toxic galactitol levels in pediatric patients with Classic Galactosemia. Dr. Riccardo Perfetti highlighted the significant correlation between galactitol levels and CNS deficit severity in patients. Approximately 3,000 individuals are affected by Galactosemia in the U.S., emphasizing the importance of ongoing clinical research and development.

Applied Therapeutics, Inc. (Nasdaq: APLT) reported its fourth-quarter and full-year financial results for 2021, showing a net loss of $105.6 million, or $4.12 per share, up from a loss of $94.0 million in 2020. The company is focused on three ongoing Phase 3 trials in Galactosemia, SORD Deficiency, and Diabetic Cardiomyopathy. A regulatory update indicates the FDA may require clinical outcomes data for the Galactosemia program before NDA submission. Cash reserves are reported at $80.8 million, down from $96.8 million in 2020, while R&D expenses increased to $62.6 million.

Applied Therapeutics, Inc. (Nasdaq: APLT) has announced its participation in two key investor conferences in March 2022. The Cowen 42nd Annual Health Care Conference will be held on March 7, 2022, with a panel discussion scheduled from 9:10 to 10:10 a.m. ET. The Barclays Global Healthcare Conference is set for March 17, 2022, featuring a presentation from 10:15 to 10:40 a.m. ET. Interested investors can access the webcast on the company's Investor Relations page and listen to replays afterward. The company focuses on developing treatments for unmet medical needs.

Applied Therapeutics (Nasdaq: APLT) is marking the 15th Annual Rare Disease Day to enhance awareness of rare diseases, specifically focusing on Galactosemia and SORD Deficiency. The company is actively supporting events like the GLOW for Galactosemia in Knoxville, Tennessee, and collaborating with advocacy partners on various initiatives. Its lead drug candidate, AT-007, aims to treat rare metabolic diseases with a high unmet medical need. The company emphasizes its commitment to developing solutions for these conditions, aligning with its clinical-stage development goals.

Applied Therapeutics, a clinical-stage biopharmaceutical company (Nasdaq: APLT), will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 11:20 a.m. ET. The event's webcast can be accessed via the company's Investor Relations page. Applied Therapeutics focuses on developing novel drug candidates for high unmet medical needs, notably with three Phase 3 programs in progress, including lead drug AT-007 for rare CNS diseases and AT-001 for Diabetic Cardiomyopathy.

Applied Therapeutics (Nasdaq: APLT) announced a regulatory update on its AT-007 Galactosemia program. Following discussions with the FDA, the company will delay submitting an NDA for AT-007, as clinical outcomes data will now likely be required for approval. The ongoing Phase 3 ACTION-Galactosemia Kids study assesses AT-007's impact on clinical outcomes, with the first assessment due in Q1 2022. Despite the disappointment, CEO Shoshana Shendelman expressed commitment to work with the FDA on the approval process.

Applied Therapeutics has launched a registrational phase 2/3 study of AT-007 targeting Sorbitol Dehydrogenase (SORD) Deficiency, a hereditary neuropathy affecting around 3,300 patients in the U.S. and 4,000 in Europe. The INSPIRE trial aims to evaluate the safety and efficacy of AT-007 compared to placebo, focusing on sorbitol reduction and clinical outcomes. Initial data from a pilot study showed a 66% reduction in blood sorbitol levels. This milestone could offer new hope for patients suffering from this debilitating condition.