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 significant leadership changes with John H. Johnson appointed as Executive Chairman, Dr. Shoshana Shendelman stepping down as CEO, and Les Funtleyder named Interim CEO. Johnson brings 40 years of pharmaceutical industry experience from companies including Johnson & Johnson and Pfizer. The company also disclosed key business updates, including the receipt of a Complete Response Letter for govorestat's NDA in Classic Galactosemia and withdrawal of the European MAA. The company has delayed its NDA submission for govorestat in SORD Deficiency treatment until after Q1 2025. As part of the appointment, Johnson received inducement awards including options for 2,000,000 shares and 1,000,000 restricted stock units.
Applied Therapeutics (APLT) received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for govorestat, a CNS-penetrant aldose reductase inhibitor for treating Classic Galactosemia. The FDA cannot approve the application citing clinical deficiencies. The company plans to request a meeting to discuss resubmission requirements or appeal the decision. Despite this setback, clinical trials showed govorestat's effectiveness in reducing galactitol levels and improving clinical outcomes in pediatric patients, including benefits in daily activities, behavior, cognition, and motor skills. The company maintains its plans to submit an NDA for govorestat in SORD Deficiency treatment in early Q1 2025.
Applied Therapeutics (APLT) reported Q3 2024 financial results with key developments in their govorestat program. The FDA's review for Classic Galactosemia treatment continues with a PDUFA date of November 28, 2024, while EMA decision is expected in Q1 2025. The company plans to submit an NDA for govorestat in SORD Deficiency in early Q1 2025. Financial results show cash position of $98.9 million as of September 30, 2024. Q3 net loss was $68.6 million ($0.48 per share), compared to $42.4 million ($0.47 per share) in Q3 2023. R&D expenses increased to $14.8 million, while G&A expenses rose to $15.0 million.
Applied Therapeutics (Nasdaq: APLT), a clinical-stage biopharmaceutical company, has announced its participation in the 2024 UBS Global Healthcare Conference. The presentation is scheduled for Tuesday, November 12, 2024, at 7:15 a.m. PT in Rancho Palos Verdes, California.
The company will provide a live webcast of the event through their website's Investor Relations section at www.appliedtherapeutics.com. Interested parties can access the presentation recording for 90 days following the event on the company's website.
Applied Therapeutics (Nasdaq: APLT) provided a regulatory update on govorestat for the treatment of Classic Galactosemia. The company completed its late-cycle review meeting with the FDA, which no longer intends to hold an Advisory Committee meeting. The FDA's review of the New Drug Application (NDA) continues as planned, with the PDUFA target action date set for November 28, 2024.
The FDA communicated that the Priority Review of the NDA is proceeding as scheduled, with alignment on post-marketing requirements expected in October 2024. Applied Therapeutics expressed satisfaction with the ongoing collaborative dialogue with the FDA and remains committed to bringing the first potential treatment to Classic Galactosemia patients.
Applied Therapeutics (Nasdaq: APLT), a clinical-stage biopharmaceutical company, has announced its participation in two upcoming investor conferences. The company will take part in:
- The Baird 2024 Global Healthcare Conference with a fireside chat on September 10, 2024, at 3:45 p.m. ET in New York, NY
- The 2024 Cantor Global Healthcare Conference with a presentation on September 18, 2024, at 10:20 a.m. ET in New York, NY
Live webcasts for both events will be available on the company's website under the Investor Relations section. Replays will be archived for 90 days following each event. Applied Therapeutics focuses on developing novel drug candidates for indications with high unmet medical needs.
Applied Therapeutics (Nasdaq: APLT) reported Q2 2024 financial results and provided updates on its drug candidate govorestat. Key highlights include:
1. FDA PDUFA target action date for govorestat in Classic Galactosemia: November 28, 2024
2. EMA decision expected in early Q1 2025
3. FDA Advisory Committee meeting tentatively scheduled for October 9, 2024
4. Planned NDA submission for govorestat in SORD Deficiency: early Q1 2025
5. Q2 2024 financials: $122.2 million cash and equivalents, $2.9 million net income ($0.02 per basic share)
6. Cash runway expected into 2026, potentially extended by Priority Review Voucher sale
Applied Therapeutics (Nasdaq: APLT) has been added to the Russell 3000® Index, effective after the U.S. market closed on June 28, 2024. This inclusion is part of the 2024 annual reconstitution of Russell indexes, which track the performance of the largest 3,000 U.S. stocks. This milestone highlights Applied Therapeutics' progress as a publicly traded company focused on developing novel drug candidates for diseases with high unmet medical needs.
CEO Shoshana Shendelman emphasized the significance of this addition, noting upcoming regulatory updates for their drug candidates, govorestat, for Classic Galactosemia and SORD Deficiency. The Russell 3000® Index is a key component of the global Russell indexes, used by investment managers and institutional investors to benchmark over $10 trillion in assets.
Applied Therapeutics, Inc. reported financial results for the first quarter of 2024, highlighting significant regulatory progress regarding the potential approval of govorestat for Classic Galactosemia in the US and EU. The Company also discussed a potential NDA submission for SORD Deficiency. Dale Hooks was appointed as Chief Commercial Officer, and full results from the Phase 3 ARISE-HF Study of AT-001 in Diabetic Cardiomyopathy were presented. Financially, the Company ended the quarter with $146.5 million in cash and cash equivalents, with a net loss of $83.9 million. The Company expects its cash to fund operations into 2026.
Applied Therapeutics, Inc. (Nasdaq: APLT) will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on May 14, 2024. The company is a clinical-stage biopharmaceutical developing drug candidates for unmet medical needs.
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?
