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Applied Therapeutics Provides Regulatory Update on Govorestat for the ...
Applied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic Galactosemia - 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 NEW YORK, Sept. 18, 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 announc...
Applied Therapeutics to Participate in Upcoming Investor Conferences
Applied Therapeutics to Participate in Upcoming Investor Conferences NEW 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 indications of high unmet medical need, today announced that the company will participate in the following upcoming investor conferences: Baird 2024 Global Healthcare Conference: Fireside chat on Tuesday, September 10, 2024, at 3:45 p.m. ET in New York, NY2024 Cantor Global Healthcare Conference: Presentati...
Applied Therapeutics Reports Second Quarter 2024 Financial Results
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 2025FDA Genetic Metabolic Diseases Advisory Committee (GeMDAC) Meeting to discuss NDA for govorestat for the treatment of Classic Galactosemia tentatively scheduled for October 9, 2024Company aligned with the Neurology I Division on plans to submit an NDA under Accelerated Approval for govorestat for the treatment of SORD Deficiency; ...
Applied Therapeutics Added to Russell 3000® Index
Applied Therapeutics Added to Russell 3000® Index 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 progress we have made as a public...
- Jonathan Moreland
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Agree Realty Corp: 2 directors
Two Directors at Agree Realty Corp bought 21,000 shares at between 58.990USD and 59.320USD. The significance rating of the trade was 68/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over ...
Applied Therapeutics Reports First Quarter 2024 Financial Results
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 2025Company discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with Neurology I Division of FDA NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company devel...
Applied Therapeutics to Present at the 2024 RBC Capital Markets Global...
Applied Therapeutics to Present at the 2024 RBC Capital Markets Global Healthcare Conference NEW 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 indications of high unmet medical need, today announced that it will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024 at 4:35 p.m. ET in New York, New York. A live webcast for this event will be accessible on the Event...
- Jonathan Moreland
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Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer
Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer 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 leadership roles. M...
Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in...
Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024 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 Sci...
Applied Therapeutics Provides FDA Update on PDUFA Target Action Date f...
Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia NEW 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 indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia by three months...
- Jonathan Moreland
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Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financia...
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 Strengthened balance sheet with $100 million Private Placement, expected to extend cash runway into 2026 NEW...
- Jonathan Moreland
Applied Therapeutics Announces $100 Million Private Placement
Applied Therapeutics Announces $100 Million Private Placement 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 it has entered into...
Applied Therapeutics Announces FDA Acceptance and Priority Review of N...
Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia PDUFA 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 biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has accepted the fi...
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