Applied Therapeutics, Inc. (APLT)

- CMT-SORD program advances; meeting scheduled with the FDA in Q3 2025 to discuss govorestat for the treatment of CMT-SORD

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), effective June 15, 2025, and Dottie Caplan to Executive Vice President (EVP), Patient Advocacy and Government Affairs.

Slowing 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 sorbitol and change in 10MWRT and CMT-FOM Lower Limb domain at 12 months, though the primary endpoint of 10MWRT at 12 months was not statistically significant (the measure has since been removed from the CMT-FOM clinical outcomes assessment based upon the results of the ACT-CMT study*) Statistically significant improvement in CMT-HI and statistically significant correlation between percent change in sorbitol and change in CMT-HI at 12 months Treatment with govorestat in CMT-SORD-Null rats demonstrated a highly statistically significant 37% (p=0.005) reduction of sorbitol in the sciatic nerve, the tissue of interest, after treatment with govorestat.Reflective of the peripheral neuropathy experienced by patients with CMT-SORD. Govorestat remains generally safe and well tolerated Company remains committed to potential NDA submission of govorestat for treatment of CMT-SORD in 2025 NEW YORK, May 18, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare disease, today presented full 12-month clinical results and new topline data from 18 and 24 months from the INSPIRE Phase 2/3 trial of govorestat (AT-007) for the treatment of Sorbitol Dehydrogenase (SORD) Deficiency, a subtype of Charcot-Marie-Tooth (CMT) disease, in an oral presentation at the Peripheral Nerve Society (PNS) 2025 Annual Meeting, being held May 17-20, 2025 in Edinburgh, Scotland.

- 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

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 extension 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 extension

Investors can contact the law firm at no cost to learn more about recovering their losses

NEW 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 molecular targets in indications of high unmet medical need, today announced that it has filed a Form 12b-25, Notification of Late Filing, with the U.S. Securities and Exchange Commission (“SEC”) related to the Company's Annual Report on Form 10-K for the fiscal year 2024 (the “Form 10-K”). Form 12b-25 will allow the Company an automatic extension of 15 additional calendar days to file the Form 10-K for the fiscal year 2024, which is due on March 31, 2025. The Company is working diligently to finalize its financial statements and currently expects to file its Annual Report on Form 10-K as soon as practicable by April 15, 2025, the end of the 15-day extension period, in accordance with Rule 12b-25.

Dr. Baumgartner will advance Applied's preparation for upcoming regulatory interactions Dr. Baumgartner will advance Applied's preparation for upcoming regulatory interactions

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information: https://zlk.com/pslra-1/applied-therapeutics-inc-lawsuit-submission-form?prid=130443&wire=1 or contact Joseph E. Levi, Esq.

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information: https://zlk.com/pslra-1/applied-therapeutics-inc-lawsuit-submission-form?prid=130340&wire=1 or contact Joseph E. Levi, Esq.

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information: https://zlk.com/pslra-1/applied-therapeutics-inc-lawsuit-submission-form?prid=130271&wire=1 or contact Joseph E. Levi, Esq.

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information: https://zlk.com/pslra-1/applied-therapeutics-inc-lawsuit-submission-form?prid=130235&wire=1 or contact Joseph E. Levi, Esq.

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Applied Therapeutics, Inc. (NASDAQ:APLT) between January 3, 2024 and December 2, 2024, both dates inclusive (the "Class Period"), of the important February 18, 2025 lead plaintiff deadline. SO WHAT: If you purchased Applied Therapeutics securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information: https://zlk.com/pslra-1/applied-therapeutics-inc-lawsuit-submission-form?prid=130186&wire=1 or contact Joseph E. Levi, Esq.

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information: https://zlk.com/pslra-1/applied-therapeutics-inc-lawsuit-submission-form?prid=130160&wire=1 or contact Joseph E. Levi, Esq.

NEW YORK, NY / ACCESS Newswire / February 18, 2025 / Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Applied Therapeutics, Inc. ("Applied Therapeutics" or "the Company") (NASDAQ:APLT) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Applied Therapeutics securities between January 3, 2024 and December 2, 2024, both dates inclusive (the "Class Period").