$APLT News
Last published 9mo ago
- 9mo agoAPLTCycle Pharmaceuticals Completes Acquisition of Applied TherapeuticsBusiness WireCycle Group Holdings Limited ("Cycle") is delighted to announce it has completed the acquisition of NASDAQ-listed Applied Therapeutics, Inc. (NASDAQ:APLT, "Applied")), a clinical-stage biopharmaceutical
- 9mo agoAPLTApplied Therapeutics Shares Letter to Stockholders Recommending Tender of Shares Following Offer Expiration ExtensionGlobeNewswireNEW YORK, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company" or "Applied"), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare
- 11mo agoAPLTCycle Pharmaceuticals to Acquire Applied TherapeuticsGlobeNewswireNEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT, "Applied")), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today
- 11mo agoAPLTApplied Therapeutics Announces Corporate UpdatesGlobeNewswireNEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today
- 1y agoAPLTApplied Therapeutics Reports Third Quarter 2025 Financial ResultsGlobeNewswire– 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
- 1y agoAPLTApplied Therapeutics Provides Update Following Meeting with FDAGlobeNewswireNEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc.
- 1y agoAPLTApplied Therapeutics Reports Second Quarter 2025 Financial ResultsGlobeNewswire- 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
- 1y agoAPLTApplied Therapeutics Announces Key Leadership AppointmentsGlobeNewswireEvan 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
- 1y agoAPLTApplied Therapeutics Presents Full 12-Month Clinical Results and New Topline Data from INSPIRE Phase 2/3 Trial of Govorestat in CMT-SORD in Late-Breaking Oral Presentation at the Peripheral Nerve Society 2025 Annual MeetingGlobeNewswireSlowing of progression of disease observed via MRI at 24 months Improvements in outcomes and reduction in sorbitol maintained through 24 months Statistically significant correlation between absolute reduction in
- 1y agoAPLTApplied Therapeutics Reports First Quarter 2025 Financial ResultsGlobeNewswire- 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
- 1y agoAPLTApplied Therapeutics Announces Acceptance of Late-Breaking Abstract for Oral Presentation at the Peripheral Nerve Society 2025 Annual MeetingGlobeNewswireNEW 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
- 1y agoAPLTApplied Therapeutics Reports Fourth Quarter and Year-end 2024 Financial ResultsGlobeNewswire- Appointed John H. Johnson as Executive Chairman; Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer; and Reena Thomas Colacot as Vice President and Head of Quality NEW YORK, April 14, 2025 (GLOBE NEWSWIRE) --
- 1y agoAPLTApplied Therapeutics Files Form 12b-25 with the Securities and Exchange CommissionGlobeNewswireNEW YORK, March 31, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated
- 1y agoAPLTApplied Therapeutics Appoints Todd F. Baumgartner, MD, MPH as Chief Regulatory OfficerGlobeNewswireNEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of
- 1y agoAPLTShareholders of Applied Therapeutics, Inc. Should Contact The Gross Law Firm Before February 18, 2025 to Discuss Your Rights - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTThe Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of February 18, 2025 in Applied Therapeutics, Inc. Lawsuit - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTApplied Therapeutics, Inc. Sued for Securities Law Violations - Investors Should Contact The Gross Law Firm for More Information - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTDEADLINE REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Applied TherapeuticsGlobeNewswireFaruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Applied Therapeutics To Contact Him Directly To Discuss Their Options If you purchased or acquired
- 1y agoAPLTApplied Therapeutics, Inc. Sued for Securities Law Violations - Investors Should Contact The Gross Law Firm Before February 18, 2025 to Discuss Your Rights - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTApplied Therapeutics Appoints Reena Thomas Colacot as Vice President and Head of QualityGlobeNewswireNEW YORK, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of
- 1y agoAPLTApplied Therapeutics, Inc. Sued for Securities Law Violations – Investors Should Contact The Gross Law Firm Before February 18, 2025 to Discuss Your Rights – APLTGlobeNewswireNEW YORK, Jan. 15, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ:APLT). Shareholders who purchased shares of APLT during the class period
- 1y agoAPLTShareholders of Applied Therapeutics, Inc. Should Contact The Gross Law Firm Before February 18, 2025 to Discuss Your Rights - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTApplied Therapeutics, Inc. Sued for Securities Law Violations - Contact The Gross Law Firm Before February 18, 2025 to Discuss Your Rights - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTInvestors in Applied Therapeutics, Inc. Should Contact The Gross Law Firm Before February 18, 2025 to Discuss Your Rights - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTShareholders of Applied Therapeutics, Inc. Should Contact The Gross Law Firm Before February 18, 2025 to Discuss Your Rights - APLTPR NewswireThe Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT). Shareholders who purchased shares of...
- 1y agoAPLTRVPHVSTMApplied Therapeutics Appoints John H. Johnson as Executive ChairmanGlobeNewswireShoshana Shendelman Steps Down as CEO; Les Funtleyder Appointed Interim Chief Executive Officer Announces Business Updates NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT),
- 1y agoAPLTWolf Popper LLP Announces Investigation on Behalf of Applied Therapeutics, Inc. InvestorsGlobeNewswireNEW YORK, Dec. 06, 2024 (GLOBE NEWSWIRE) -- Wolf Popper LLP is investigating potential claims on behalf of purchasers of Applied Therapeutics, Inc. ("Applied Therapeutics") common stock (NASDAQ:APLT). Applied
- 1y agoAPLTApplied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic GalactosemiaGlobeNewswireNEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and
- 2y agoAPLTApplied Therapeutics Reports Third Quarter 2024 Financial ResultsGlobeNewswire- NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in Q1 2025 - NDA submission for
- 2y agoAPLTApplied Therapeutics to Present at the 2024 UBS Global Healthcare ConferenceGlobeNewswireNEW YORK, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 2y agoAPLTApplied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic GalactosemiaGlobeNewswire- Company completed Late-Cycle review meeting with FDA - FDA no longer intends to hold Advisory Committee meeting - FDA Review of NDA continues to proceed as planned with PDUFA target action date of November 28, 2024
- 2y agoAPLTApplied Therapeutics to Participate in Upcoming Investor ConferencesGlobeNewswireNEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 2y agoAPLTApplied Therapeutics Reports Second Quarter 2024 Financial ResultsGlobeNewswireNDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in early Q1 2025FDA Genetic Metabolic
- 2y agoAPLTApplied Therapeutics Added to Russell 3000® IndexGlobeNewswireNEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 2y agoAPLTApplied Therapeutics Reports First Quarter 2024 Financial ResultsGlobeNewswireGovorestat NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024 Govorestat MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision expected in early
- 2y agoAPLTApplied Therapeutics to Present at the 2024 RBC Capital Markets Global Healthcare ConferenceGlobeNewswireNEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 2y agoAPLTApplied Therapeutics Appoints Dale Hooks as Chief Commercial OfficerGlobeNewswireNEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 2y agoAPLTApplied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024GlobeNewswireNEW YORK, April 04, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 2y agoAPLTApplied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic GalactosemiaGlobeNewswireNEW YORK, March 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 2y agoAPLTApplied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial ResultsGlobeNewswireNDA for govorestat accepted and granted Priority Review by FDA for the treatment of Classic Galactosemia; PDUFA target action date of August 28, 2024; MAA under review by EMA with decision expected in 4Q 2024 Announced
- 2y agoAPLTApplied Therapeutics Announces $100 Million Private PlacementGlobeNewswireFinancing includes significant participation from a number of large healthcare dedicated institutional and mutual fund investors Net proceeds, along with existing cash and cash equivalents, are expected to extend cash
- 2y agoAPLTApplied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic GalactosemiaGlobeNewswirePDUFA target action date of August 28, 2024 MAA validated and accepted for review by EMA in December 2023 NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage
- 2y agoAPLTApplied Therapeutics Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in Sorbitol Dehydrogenase (SORD) DeficiencyGlobeNewswireInterim primary endpoint met; Statistically significant correlation of sorbitol with the CMT-FOM clinical outcome composite (p=0.05) Sustained, statistically significant reduction in sorbitol in govorestat-treated
- 2y agoAPLTApplied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic CardiomyopathyGlobeNewswireAT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months AT-001 treatment resulted in a statistically significant difference in cardiac
- 2y agoAPLTApplied Therapeutics Announces MAA Validation and NDA Submission of Govorestat (AT-007) for Treatment of Classic GalactosemiaGlobeNewswireNDA submitted to FDA and MAA validated by EMA in December 2023 Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term clinical outcomes
- 3y agoAPLTApplied Therapeutics Reports Third Quarter 2023 Financial ResultsGlobeNewswireRegulatory submissions on track for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA in 4Q 2023 Two Upcoming Phase 3 Trial Readouts, with ARISE-HF Trial of AT-001 (caficrestat) in Diabetic
- 3y agoAPLTApplied Therapeutics to Present at the UBS Biopharma Conference 2023GlobeNewswireNEW YORK, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in
- 3y agoAPLTApplied Therapeutics to Host Diabetic Cardiomyopathy Expert Forum with Key Opinion Leaders on Tuesday, November 7GlobeNewswireForum to be Webcast Live Topline Phase 3 Data Readout from ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy On Track for 4Q 2023 NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc.
- 3y agoAPLTApplied Therapeutics to Present Baseline Data from Phase 3 ARISE-HF Study Evaluating AT-001 at the 2023 EASD Annual MeetingGlobeNewswireThe ongoing ARISE-HF Phase 3 global clinical trial is evaluating the efficacy of AT-001 (caficrestat) on cardiac functional capacity in patients with diabetic cardiomyopathy (DbCM)Baseline data from ARISE-HF
- 3y agoAPLTApplied Therapeutics Announces Successful Pre-NDA Meeting with the FDA and Confirms Plans to Submit NDA for Govorestat (AT-007) for Treatment of Classic Galactosemia to FDA in Q4 2023GlobeNewswireNEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in