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Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops novel products to target cardiovascular disease, galactosemia, and diabetic complications. Its lead product candidate is AT-007 that has completed phase 1/2 for the treatment of galactosemia in healthy volunteers and adults, as well as is in pediatric clinical study for the treatment of galactosemia in kids; for treating sorbitol dehydrogenase deficiency; and for the treatment of phosphomannomutase enzyme-CDG. The company also develops AT-001 that is in phase III clinical trials for treating diabetic cardiomyopathy, as well as for the treatment of diabetic peripheral neuropathy. Its preclinical stage products include AT-003 for the treatment diabetic retinopathy; AT-104, a PI3K inhibitor for treating orphan hematological oncology T Cell Acute Lymphoblastic Leukemia. Applied Therapeutics, Inc. was incorporated in 2016 and is headquartered in New York, New York.

Applied Therapeutics, Inc.

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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 QUARTER OF 2025.

APPLIED THERAPEUTICS PROVIDES UPDATE FOLLOWING MEETING WITH FDA

- CMT-SORD PROGRAM ADVANCES; MEETING SCHEDULED WITH THE FDA IN Q3 2025 TO DISCUSS GOVORESTAT FOR THE TREATMENT OF CMT-SORD

APPLIED THERAPEUTICS REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS

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.

APPLIED THERAPEUTICS ANNOUNCES KEY LEADERSHIP APPOINTMENTS

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 THEPERIPHERAL 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.

APPLIED 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 MEETING

- 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

APPLIED THERAPEUTICS REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS

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

APPLIED THERAPEUTICS ANNOUNCES ACCEPTANCE OF LATE-BREAKING ABSTRACT FOR ORAL PRESENTATION AT THE PERIPHERAL NERVE SOCIETY 2025 ANNUAL MEETING

INVESTORS CAN CONTACT THE LAW FIRM AT NO COST TO LEARN MORE ABOUT RECOVERING THEIR LOSSES

NET POWER INC. INVESTORS: PLEASE CONTACT THE PORTNOY LAW FIRM TO RECOVER YOUR LOSSES. JUNE 17, 2025 DEADLINE TO FILE LEAD PLAINTIFF MOTION

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.

APPLIED THERAPEUTICS FILES FORM 12B-25 WITH THE SECURITIES AND EXCHANGE COMMISSION

DR. BAUMGARTNER WILL ADVANCE APPLIED'S PREPARATION FOR UPCOMING REGULATORY INTERACTIONS DR. BAUMGARTNER WILL ADVANCE APPLIED'S PREPARATION FOR UPCOMING REGULATORY INTERACTIONS

APPLIED THERAPEUTICS APPOINTS TODD F. BAUMGARTNER, MD, MPH AS CHIEF REGULATORY OFFICER

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.

Applied Therapeutics, Inc.

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Applied Therapeutics, Inc.

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