Applied Therapeutics, Inc. - APLT STOCK NEWS

Applied Therapeutics (Nasdaq: APLT) announced positive results from the ACTION-Galactosemia Kids trial for govorestat, a treatment for Galactosemia. The trial demonstrated long-term clinical benefits in improving daily activities, behavior, cognition, and motor skills compared to placebo. Although not statistically significant on the primary endpoint, systematic improvements were observed. The company plans to request a pre-NDA meeting with the FDA and submit a Marketing Authorization Application with the EMA in mid-2023. Approximately 3,000 patients in the US and 4,000 in the EU suffer from Galactosemia, indicating a significant market need.

Applied Therapeutics reported progress in three Phase 3 trials, focusing on crucial unmet medical needs. Notably, the company announced positive interim results from the Phase 3 INSPIRE trial, showing a 52% reduction in sorbitol levels with AT-007 in patients with SORD Deficiency. The company also partnered with Advanz Pharma for commercialization in Europe, with potential milestone payments exceeding €130 million. Financially, cash reserves dropped to $30.6 million, while net loss improved to $82.5 million, or $2.18 per share, down from $105.6 million. Overall, the company is positioned for upcoming data readouts in 2023.

Applied Therapeutics, a clinical-stage biopharmaceutical company (Nasdaq: APLT), will participate in the Neuromuscular & Bone Panel at the Cowen 43rd Annual Health Care Conference on March 8, 2023, at 2:10 p.m. ET in Boston. This participation highlights the company’s ongoing commitment to addressing high unmet medical needs.

The event will be accessible via webcast on their Investor Relations page, with a replay available afterward. Applied Therapeutics is advancing novel drug candidates, including AT-007 for CNS rare metabolic diseases and AT-001 for Diabetic Cardiomyopathy.

Applied Therapeutics announced positive results from the ongoing Phase 3 INSPIRE trial for AT-007 in patients with SORD Deficiency. The trial is assessing the drug's effect on sorbitol reduction and clinical outcomes among approximately 50 patients aged 16-55 in the US and Europe. AT-007 demonstrated a significant mean sorbitol reduction of 52% (approximately 16,000 ng/ml) over 90 days compared to placebo (p<0.001). The company is collaborating with the FDA to determine the regulatory pathway for a New Drug Application (NDA). Continued monitoring will assess clinical outcome measures over 12 to 24 months.

Applied Therapeutics (Nasdaq: APLT) will present virtually at the SVB Securities Global Biopharma Conference on February 16, 2023, at 2:20 p.m. ET. Interested parties can access the webcast via the Events page on the company's investor relations website, with a replay available afterward.

The company focuses on developing novel drug candidates targeting high unmet medical needs. Its lead candidate, AT-007, aims to treat CNS rare metabolic diseases, while AT-001 targets Diabetic Cardiomyopathy. Preclinical development includes AT-003 for Diabetic Retinopathy.

Applied Therapeutics (APLT) has partnered with Advanz Pharma to commercialize AT-007 in Europe for Galactosemia and SORD Deficiency. The deal includes milestone payments exceeding €130 million and a 20% royalty on future net sales. This partnership is expected to enhance Applied Therapeutics' capital position and extends its cash runway through critical milestones. Advanz will oversee the packaging and distribution, while Applied Therapeutics remains responsible for development and manufacturing.

Applied Therapeutics (NASDAQ: APLT) reported its Q3 2022 financial results, with significant advancements in its pipeline, including full enrollment in Phase 3 trials for AT-001 in Diabetic Cardiomyopathy and encouraging trends in the ACTION-Galactosemia Kids trial for AT-007. Cash and equivalents stood at $47.4 million, down from $80.8 million at year-end 2021. R&D expenses decreased to $13.1 million from $17.6 million year-over-year, while G&A expenses fell to $6.2 million from $10.8 million. The net loss narrowed to $19.1 million, or $0.40 per share, compared to a $28.4 million loss in Q3 2021.

Applied Therapeutics (Nasdaq: APLT) reported promising preclinical data supporting its investigational treatment, AT-001, for Diabetic Cardiomyopathy. Key findings show AT-001 effectively reduces cardiac fibrosis and prevents adverse remodeling. The ongoing Phase 3 ARISE-HF study emphasizes the importance of cardiac functional capacity, measured by Peak VO2, for patients' quality of life. This data will be presented at the American Heart Association Scientific Sessions from November 5-7, 2022, alongside additional insights into Diabetic Cardiomyopathy's diagnosis and prevalence.

Applied Therapeutics has announced the full enrollment of 675 patients in the Phase 3 ARISE-HF trial, evaluating AT-001 for treating Diabetic Cardiomyopathy (DbCM). This study, which is placebo-controlled and double-blinded, aims to measure cardiac functional capacity after 15 months. DbCM affects about 20% of Type 2 Diabetes patients, representing a substantial market opportunity. If successful, AT-001 could become the first approved treatment for DbCM. Topline data is expected by early 2024, with plans for additional long-term data collection.