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Can Changes in Leadership and FDA Dialogue Reshape Applied Therapeutics’ (APLT) Path in Rare Diseases?
Applied Therapeutics reported its third quarter 2025 results, highlighting US$1 million in revenue and a reduced net loss of US$18.99 million, and announced the resignation of Executive Chairman John Johnson for personal reasons. Recent regulatory updates on key drug candidates, ongoing R&D progress, and out-licensing arrangements are shaping expectations around the company’s future growth opportunities in rare diseases. We’ll explore how the dialogue with the FDA about govorestat’s clinical... Nov 15, 2025 - $APLT
Applied Therapeutics Reports Third Quarter 2025 Financial Results
– Update on regulatory strategy for govorestat for the treatment of CMT-SORD following receipt of Type C meeting minutes – Meeting scheduled with the FDA in 4Q 2025 to discuss govorestat for the treatment of Classic Galactosemia – New data on govorestat for the treatment of PMM2-CDG published in JIMD and presented at the 2025 ASHG Annual Meeting – Announces Board of Directors Leadership Transition NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company Nov 13, 2025 - $APLT
Applied Therapeutics Provides Update Following Meeting with FDA
NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the Company), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced that the Company completed a meeting with the U.S. Food and Drug Administration (FDA) to discuss the potential new drug application (NDA) submission for govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (SORD) Deficiency (CMT-SORD) in the third qu Sep 29, 2025 - $APLT
Applied Therapeutics Reports Second Quarter 2025 Financial Results
- CMT-SORD program advances; meeting scheduled with the FDA in Q3 2025 to discuss govorestat for the treatment of CMT-SORD - Presented full 12-month clinical results and new topline data from INSPIRE Phase 2/3 trial of govorestat for the treatment of CMT-SORD at PNS 2025 Annual Meeting highlighting slowed progression of disease observed via MRI at 24 months - Launched new sponsored Sorbitol Assay to support identification of patients suspected of having CMT-SORD - Entered into out-licensing agre Aug 13, 2025 - $APLT
Applied Therapeutics Announces Key Leadership Appointments
Evan Bailey, MD, promoted to Chief Medical Officer, succeeding Riccardo Perfetti, MD, PhDDottie Caplan promoted to Executive Vice President, Patient Advocacy and Government Affairs NEW YORK, June 17, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced key appointments to its executive leadership team with the promotions of Evan Bailey, MD, to Chief Medical Officer (CMO), Jun 17, 2025 - $APLT
Applied Therapeutics Reports First Quarter 2025 Financial Results
- Company to present full 12-month clinical data and new topline 18-month and 24-month data from INSPIRE registrational Phase 3 trial of govorestat in CMT-SORD Deficiency at the Peripheral Nerve Society 2025 Annual Meeting - Review of govorestat development programs for Classic Galactosemia and CMT-SORD Deficiency ongoing NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company dedicated to creating transform May 13, 2025 - $APLT
Applied Therapeutics Announces Acceptance of Late-Breaking Abstract for Oral Presentation at the Peripheral Nerve Society 2025 Annual Meeting
Late-breaking oral presentation to include full 12-month clinical data from INSPIRE registrational Phase 3 trial in addition to topline 18-month and 24-month data from patients prior to open-label extensionNEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced that it will present full 12-month clinical results from the INSPI May 9, 2025 - $APLT
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