Applied Therapeutics(APLT)
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Applied Therapeutics(APLT) - 2024 Q2 - Quarterly Results
2024-08-07 11:08
Exhibit 99.1 Applied Therapeutics Reports Second Quarter 2024 Financial Results - 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 early Q1 2025 - FDA Genetic Metabolic Diseases Advisory Committee (GeMDAC) Meeting to discuss NDA for govorestat for the treatment of Classic Galactosemia tentatively scheduled for October 9, 2024 - Company aligned with the Neurology I Division on ...
Rare Disease-Focused Applied Therapeutics' Lead Candidate Govorestat Has Blockbuster Potential, Analyst Sees 140% Stock Upside
Benzinga· 2024-07-31 18:37
William Blair initiated coverage on Applied Therapeutics Inc. APLT, a late-stage development company focused on rare diseases such as galactosemia, SORD deficiency, and diabetic cardiomyopathy.The analyst says, “Applied Therapeutics is an under-the-radar company developing a nice mix of therapeutics targeting rare diseases and some larger indications with potential for several major value inflections over the next 12 months.”In April, the FDA extended the review period for Applied Therapeutics’ marketing ap ...
Applied Therapeutics Added to Russell 3000® Index
GlobeNewswire News Room· 2024-07-01 11:00
NEW 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 indications of high unmet medical need, today announced that the Company was added to the Russell 3000® Index, effective after the U.S. market closed on June 28, 2024, as part of the 2024 Russell indexes annual reconstitution. “The addition of Applied to the Russell 3000® index underscores the p ...
Applied Therapeutics: A Strong Buy With AT-007 Nearing Approval For Galactosemia
seekingalpha.com· 2024-05-29 07:19
Md Babul Hosen/iStock via Getty Images Applied Therapeutics, Inc. (NASDAQ:APLT) is a promising clinical-stage biotech that focuses on treating symptoms of galactosemia in the central nervous system [CNS]. Galactosemia is rare when the body lacks a particular enzyme that metabolizes galactose. As a result, galactose and galacticol accumulate, leading to aberrant neuronal activity due to toxic levels of aldose reductase [AR] in cells. This can cascade into potentially serious adverse effects if left untreated ...
Applied Therapeutics(APLT) - 2024 Q1 - Quarterly Report
2024-05-09 11:17
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 March 31, 2024 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 Ch ...
Applied Therapeutics(APLT) - 2024 Q1 - Quarterly Results
2024-05-09 11:13
Exhibit 99.1 Applied Therapeutics Reports First Quarter 2024 Financial Results - Govorestat 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 Q1 2025 - Company discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with Neurology I Division of FDA NEW YORK, May 9, 2024 – Applied Therapeutics, Inc ...
Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer
Newsfilter· 2024-04-15 11:00
NEW 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 indications of high unmet medical need, today announced the appointment of Dale Hooks as Chief Commercial Officer, replacing Adam Hansard, effective immediately. Mr. Hooks joins Applied with over 30 years of biopharmaceutical experience in rare disease marketing and sales, holding various leader ...
Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024
Newsfilter· 2024-04-04 11:00
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 (APLT) Surges 124% in a Month: Here's Why
Zacks Investment Research· 2024-03-13 14:26
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 ...
Applied Therapeutics(APLT) - 2023 Q4 - Annual Results
2024-03-05 16:00
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 ...