NEW 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 indications of high unmet medical need, today announced that it will present full results from the Phase 3 ARISE-HF study evaluating AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM) in an oral presentation at the 2024 American College of Cardiology (ACC) Annual Scientific Session to take p ...

Applied Therapeutics, Inc. (APLT) , a clinical-stage company, is currently focused on developing novel therapies against rare neurological, cardiac and ophthalmic disorders where there are high unmet medical needs.The company’s lead candidate is govorestat (also known as AT-007), a novel central nervous system penetrant ARI, which is being developed for three rare neurological diseases at present, including galactosemia, sorbitol dehydrogenase (SORD) deficiency and phosphomannomutase 2 deficiency.Apart from ...

Exhibit 99.1 Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results - NDA 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 positive results from 12-month interim analysis of govorestat in ongoing INSPIRE Phase 3 trial in SORD Deficiency; Company plans to request pre-NDA meeting with neurology division of FDA - Strengt ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38898 Applied Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3405262 (State ...

Applied Therapeutics (NASDAQ:APLT) stock is on the rise Wednesday after the clinical-stage biopharmaceutical company got an update from the Food and Drug Administration (FDA).The FDA has accepted the company’s New Drug Application (NDA) for govorestat as a treatment for Classic Galactosemia. It was also granted Priority Review status with a target action date of Aug. 28, 2024.To go along with this, the FDA is planning an advisory committee meeting to review the NDA for govorestat. Investors will note that t ...

Financing 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 runway into 2026 NEW YORK, Feb. 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 indications of high unmet medical need, today announced that i ...

AndreyPopov/iStock via Getty ImagesApplied Therapeutics (NASDAQ:APLT) announced positive 12-month interim results from its phase 3 INSPIRE study using AT-007 for the treatment of patients with Sorbitol dehydrogenase deficiency [SORD deficiency]. The last time I spoke about this biotech, I noted that it had several value generating inflection points using AT-007 for the treatment of patients with rare diseases. I spoke about such possible inflection points in a prior Seeking Alpha article entitled "Appli ...

Interim 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 patients vs. placebo (p<0.001) Highly statistically significant effects on the CMT Health Index (CMT-HI) patient reported outcome measure (p=0.01), with benefit of govorestat on categories of lower limb function, mobility, fatigue, pain, sensory function, and upper limb function Company plans to ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-38898 Applied Therapeutics, Inc. (Exact Name of Registrant as Specified in it ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-38898 Applied Therapeutics, Inc. (Exact Name of Registrant as Specified in its Cha ...