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 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 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...
A director at Opko Health Inc bought 500,000 shares at 0.874USD and the significance rating of the trade was 60/100. 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 the last two years clear...
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...
AIDS Clinical Trial Group Presents Results from Phase 1 Study of ModeX Trispecific Antibody for the Treatment and Prevention of HIV • Study delivers first clinical safety and pharmacokinetic data as proof of concept for the use of multispecific antibodies in humans• Candidate showed similar half-life to standard monoclonal antibodies and minimal anti-drug antibodies WESTON, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced results from a Phase 1 clinical study of SAR441236, its trispecific broadly neutralizing ant...
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 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...
OPKO Health Reports Fourth Quarter 2023 Business Highlights and Financial Results Conference call begins at 4:30 p.m. Eastern time today MIAMI, Feb. 27, 2024 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and 12 months ended December 31, 2023. Business highlights from the fourth quarter and subsequent weeks included the following: ModeX advanced its antiviral and immune-oncology product pipeline. ModeX advanced its pipeline of antiviral and immune-oncology programs utilizing its next-generation multispecific antibodi...
Moody's Investors Service ("Moody's") assigned A2 ratings to Honeywell International Inc.'s ("Honeywell") new senior unsecured notes. The issuances do not impact other ratings of Honeywell, including the existing A2 senior unsecured and P-1 short-term ratings. The outlook remains positive. Proceed...
OPKO Health to Report Fourth Quarter 2023 Financial Results on February 27, 2024 MIAMI, Feb. 22, 2024 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) plans to report operating and financial results for the three and 12 months ended December 31, 2023 after the close of the U.S. financial markets on Tuesday, February 27, 2024. OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on February 27th beginning at 4:30 p.m. Eastern time. CONFERENCE CALL & WEBCAST INFORMATION OPKO encourages ...
Applied Therapeutics Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in Sorbitol Dehydrogenase (SORD) Deficiency 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
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