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2024-03-06 07:31:25 ET More on Applied Therapeutics Applied Therapeutics: Speedy Regulatory Review Of Govorestat Might Be Possible Applied Therapeutics: Update Following Failure In Diabetic Cardiomyopathy (Downgrade) ARISE-HF Phase 3 Trial Likely To Disappoint Due To...
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 o...
2024-02-28 10:12:47 ET InvestorPlace - Stock Market News, Stock Advice & Trading Tips Coupang (NYSE: CPNG ) stock is on the rise Wednesday following the release of the e-commerce company’s earnings report for the fourth quarter of 2023 . The good news ...
2024-02-28 09:48:06 ET InvestorPlace - Stock Market News, Stock Advice & Trading Tips 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). ...
Shares of Applied Therapeutics, Inc. (NASDAQ: APLT) traded at a new 52-week high today and are currently trading at $8.73. So far today, approximately 6.12M shares have been exchanged, as compared to an average 30-day volume of 2.85M shares. Applied Therapeutics, Inc., a clinical-stage biopha...
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) -- Ap...
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 candidate...
2024-02-16 15:25:00 ET Summary Positive 12-month interim results from the phase 3 INSPIRE study using govorestat for the treatment of patients with SORD deficiency achieved. Pre-NDA meeting with FDA to be sought out after to see if an NDA submission of govorestat for SORD deficien...
2024-02-16 12:56:48 ET More on Applied Therapeutics Applied Therapeutics: Update Following Failure In Diabetic Cardiomyopathy (Downgrade) ARISE-HF Phase 3 Trial Likely To Disappoint Due To Multiple Red Flags Applied Therapeutics: Multiple Inflection Points Could Gene...
2024-02-16 12:29:21 ET Gainers: Pop Culture Group Co Ltd ( CPOP ) +176% . Fusion Fuel Green Ltd ( HTOO ) +127% . MicroCloud Hologram ( HOLO ) +118% . Nano X Imaging Ltd ( NNOX ) +48% . MoneyHero Ltd ( MNY ) +46% . Tarena Inte...
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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...