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 (Nasdaq: APLT) announced a poster presentation at the 2021 Annual Clinical Genetics Meeting of ACMG, held from April 13-16. The presentation focuses on the progressive worsening of the central nervous system phenotype in children with Classic Galactosemia. Riccardo Perfetti, Chief Medical Officer, stated the urgency for disease-modifying therapies based on the findings. The poster, titled 'Progressive Worsening of CNS Phenotype in Children with Classic Galactosemia', will be accessible on the ACMG website.
Applied Therapeutics (APLT) recently announced important developments including the resumption of the AT-007 ACTION-Galactosemia Kids pediatric clinical study, with a New Drug Application (NDA) submission targeted for Q3 2021.
The company also successfully closed a public offering, raising approximately $74.3 million, enhancing its cash position to $96.8 million. Additionally, research and development expenses surged to $61.8 million, reflecting increased clinical activities. However, the net loss for 2020 widened to $94.0 million, indicating growing financial challenges.
Applied Therapeutics (Nasdaq: APLT) announces a Virtual Rare Disease Forum on March 23, 2021, from 1:00pm to 3:00pm ET to showcase its drug development programs for Galactosemia, SORD Deficiency, and PMM2-CDG. Key updates will include insights on the ACTION-Galactosemia program and updates on SORD and PMM2-CDG clinical development plans. The event aims to highlight the potential of its lead candidate AT-007 in addressing rare diseases. An audio webcast will be available live, with details found on their official website.
Applied Therapeutics, Inc. (Nasdaq: APLT) announced its participation in two investor conferences in March 2021. The first is the Cowen 41st Annual Health Care Conference on March 2, 2021, from 9:10 to 9:40 a.m. ET. The second is the Barclays Global Healthcare Conference scheduled for March 9, 2021, from 4:45 to 5:10 p.m. ET. The webcasts will be available on their website's Investor Relations section, with a replay option post-event. Applied Therapeutics develops novel drug candidates targeting high unmet medical needs, including treatments for rare diseases.
Applied Therapeutics (NASDAQ: APLT) has completed a public offering of 3,000,000 shares at $23.00 each, raising approximately $64.6 million net of expenses. The offering closed on February 17, 2021, with underwriters exercising an option for an additional 450,000 shares. The funds will be utilized to advance clinical and preclinical development of its drug candidates and general corporate purposes. The offering was managed by Goldman Sachs & Co. LLC, Cowen, and UBS Investment Bank.
Applied Therapeutics, Inc. (NASDAQ: APLT) has priced its underwritten public offering of 3,000,000 shares at $23.00 per share, expected to generate gross proceeds of $69 million. The offering, which could increase by an additional 450,000 shares if underwriters exercise their options, will close on February 17, 2021. The funds will be utilized for advancing clinical and preclinical developments as well as general corporate purposes. Goldman Sachs, Cowen, and UBS are the joint book-running managers for this offering.
Applied Therapeutics (NASDAQ: APLT) announced a public offering of 3,000,000 shares of its common stock, with an additional 450,000 shares available for underwriters. The company plans to use the proceeds for clinical and preclinical development, commercialization efforts, and general corporate purposes. Goldman Sachs, Cowen, and UBS are the joint book-running managers for this offering. The offering's completion is subject to market conditions, and the company emphasizes that this press release does not constitute an offer to sell these securities.
Applied Therapeutics announced that the FDA has lifted the clinical hold on its AT-007 ACTION-Galactosemia Kids study, allowing it to resume immediately. The study is now a combined two-part trial to ensure seamless treatment for patients. All randomized patients can return, with full enrollment expected within weeks. The company targets an NDA submission by Q3 2021. AT-007 aims to treat Galactosemia, having shown positive results in reducing toxic galactitol levels in preliminary studies, and holds Orphan Designation and Pediatric Rare Disease Voucher status.
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.
FAQ
What is the current stock price of Applied Therapeutics (APLT)?
What is the market cap of Applied Therapeutics (APLT)?
What is the primary focus of Applied Therapeutics, Inc.?
What is govorestat (AT-007)?
What are the recent achievements of Applied Therapeutics?
What other drugs are in the Applied Therapeutics pipeline?
How is govorestat expected to benefit patients with Galactosemia?
What recent financial activities has Applied Therapeutics undertaken?
What is the status of govorestat's regulatory review?
Where is Applied Therapeutics headquartered?
What are AT-001 and AT-003 intended to treat?
How can I learn more about Applied Therapeutics?
