Welcome to our dedicated page for Applied Therapeutics news (Ticker: APLT), a resource for investors and traders seeking the latest updates and insights on Applied Therapeutics stock.
Applied Therapeutics, Inc. (Nasdaq: APLT) is a clinical-stage biopharmaceutical company headquartered at 3104 Cherry Palm Dr, Tampa, FL. The company focuses on creating novel drug candidates targeting validated molecular markers for diseases with high unmet medical needs.
Currently, the company has several promising compounds in its pipeline. The lead candidate is govorestat (AT-007), a central nervous system penetrant Aldose Reductase Inhibitor (ARI) designed to treat rare metabolic diseases like Classic Galactosemia, SORD Deficiency, and PMM2-CDG. Govorestat has shown significant clinical benefits in reducing toxic metabolites like galactitol and sorbitol, leading to improvements in activities of daily living, cognitive skills, and motor functions in both adult and pediatric patients.
In recent achievements, Applied Therapeutics has completed Phase 3 trials for govorestat in treating Classic Galactosemia and SORD Deficiency, receiving Priority Review status for its New Drug Application (NDA) from the U.S. FDA. The company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). Additionally, Applied Therapeutics is preparing for the commercial launch of govorestat upon potential approval by regulatory authorities.
Other key pipeline candidates include AT-001 for Diabetic Cardiomyopathy (DbCM) and AT-003 for Diabetic Retinopathy. AT-001 has shown favorable results in stabilizing cardiac functional capacity in patients with DbCM and is safe and well-tolerated. AT-003, still in preclinical development, is designed to address diabetic retinopathy.
Financially, Applied Therapeutics reported strong progress, raising $100 million in a private placement to extend its cash runway into 2026. This funding supports its clinical and commercial activities, ensuring sustained growth and development.
To learn more about Applied Therapeutics, visit their official website at www.appliedtherapeutics.com and follow them on Twitter @Applied_Tx.
Applied Therapeutics, a clinical-stage biopharmaceutical company, has announced a definitive securities purchase agreement for the private placement of 9,735,731 shares of common stock at $0.946 each and 22,000,000 pre-funded warrants at $0.945, with gross proceeds expected to total approximately $30 million. This transaction is led by Venrock Healthcare Capital Partners and is set to close around April 26, 2023. The funds will be allocated to research and development, pipeline candidate registration, and general corporate purposes, extending the company's operational runway through mid-2024. The securities are not registered under the Securities Act and will require a registration statement for resale.
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.
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