Applied Therapeutics Stock Price, News & Analysis

Applied Therapeutics (APLT) reported Q1 2025 financial results and provided updates on its govorestat development programs. The company will present full 12-month clinical data and new topline 18-month and 24-month data from the INSPIRE Phase 3 trial for CMT-SORD Deficiency at the PNS 2025 Annual Meeting. Financial highlights include: cash position of $50.8M (down from $79.4M in Dec 2024), reduced R&D expenses of $7.8M (vs $12.2M in Q1 2024), increased G&A expenses of $17.7M (vs $9.1M), and a net loss of $21.8M ($0.15 per share). The company continues to evaluate its response to the FDA's Complete Response Letter for govorestat in Classic Galactosemia and is working to understand regulatory requirements for potential accelerated approval in CMT-SORD Deficiency.

Applied Therapeutics (NASDAQ: APLT) announced that full 12-month clinical data from the INSPIRE Phase 3 trial of govorestat (AT-007) has been accepted for a late-breaking oral presentation at the Peripheral Nerve Society (PNS) 2025 Annual Meeting in Edinburgh, Scotland. The presentation will also include new topline 18-month and 24-month data from patients before their transition to the open-label extension study.

The INSPIRE Phase 3 trial was a double-blind, placebo-controlled registrational study evaluating govorestat's effect in patients with Sorbitol Dehydrogenase (SORD) Deficiency, a subtype of Charcot-Marie-Tooth (CMT) disease. The company previously released topline results from the 12-month group-level data analysis in February 2024.

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Applied Therapeutics (NASDAQ: APLT) reported its Q4 and full-year 2024 financial results, highlighting key leadership appointments and program developments. The company ended 2024 with $79.4 million in cash, up from $49.9 million in 2023.

Financial metrics show a net loss of $105.6 million ($0.76 per share) for 2024, compared to $119.8 million ($1.42 per share) in 2023. R&D expenses decreased to $48.7 million from $53.9 million, while G&A expenses increased to $56.0 million from $20.6 million.

The company is evaluating its response to the FDA's Complete Response Letter for govorestat in Classic Galactosemia treatment and continues developing the drug for SORD Deficiency. Recent appointments include John H. Johnson as Executive Chairman, Les Funtleyder as Interim CEO, Todd F. Baumgartner as Chief Regulatory Officer, and Reena Thomas Colacot as VP of Quality.

Applied Therapeutics (Nasdaq: APLT) has filed Form 12b-25 with the SEC, requesting a 15-day extension for submitting its 2024 Annual Report on Form 10-K. The clinical-stage biopharmaceutical company, which develops novel drug candidates for high unmet medical needs, was originally required to file by March 31, 2025.

The company is currently working to finalize its financial statements and expects to file the report by April 15, 2025, the deadline of the extension period. Applied Therapeutics will announce its Q4 and full-year 2024 earnings results once the Form 10-K filing date is confirmed.

Applied Therapeutics (Nasdaq: APLT) has appointed Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer. Dr. Baumgartner brings over 35 years of experience in regulatory, clinical development, and medical affairs roles, with a track record of leading 12 successful New Drug Applications and marketing authorizations.

As part of the executive leadership team, he will lead Applied's global regulatory strategy, particularly focusing on upcoming regulatory interactions regarding govorestat. Prior to this appointment, Dr. Baumgartner served as Senior Vice President of Global Regulatory Affairs at Ovid Therapeutics (2020-2024) and held senior positions at Acorda Therapeutics, Purdue Pharma, AstraZeneca, and Bristol-Myers Squibb.

Applied Therapeutics (NASDAQ: APLT) has appointed Reena Thomas Colacot as Vice President and Head of Quality in a newly created role. She brings over 25 years of quality leadership experience in the biopharmaceutical and medical device industries. Colacot will report to the executive leadership team and Executive Chairman, overseeing all quality matters including Good Manufacturing, Laboratory, and Clinical Practices.

Prior to joining Applied Therapeutics, Colacot led quality and compliance functions at Bellus Health, Inc., continuing through its acquisition by GSK plc in 2023. Her experience includes leadership roles at Quotient Sciences, International AIDS Vaccine Initiative, Antares Pharma, McNeil Consumer Healthcare, and Laureate Pharma/Purdue Biopharma. She holds M.S. degrees in Quality Assurance and Regulatory Affairs from Temple University and Biomedical Engineering from the University of Alabama at Birmingham.

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.