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Toggle Summary RedHill Biopharma Announces Positive Top-Line Safety and Efficacy Data from Phase 2 COVID-19 Study of Opaganib
Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of ...
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Toggle Summary RedHill's Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue
Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 treated patients Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021 Top-line data ...
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Toggle Summary RedHill's Phase 2/3 COVID-19 Candidate Opaganib Reduces ARDS-Related Blood Clotting in Preclinical Model
Acute respiratory distress syndrome (ARDS)-induced thrombosis (blood clotting) may occur in up to one-third of COVID-19 patients requiring ICU admission and is a contributing cause of mortality Opaganib demonstrated reduced thrombosis in a preclinical model of ARDS Opaganib has also been shown to ...
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Toggle Summary RedHill Biopharma Added to NASDAQ Biotechnology Index
TEL AVIV, Israel and RALEIGH, N.C. , Dec. 14, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the company was selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI). ...
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Toggle Summary RedHill Biopharma Extends Talicia® Unrestricted National and Regional Commercial Coverage to Over 40 Million Additional Americans
Talicia® unrestricted access in the U.S. now extends to over 70% of commercial lives covered Approximately 35% of Americans are affected by H. pylori infection, a Group 1 carcinogen and the strongest risk factor for gastric cancer; eradication of H. pylori has been shown to reduce the risk of ...
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Toggle Summary RedHill Biopharma Expands U.S.-Based Manufacturing Capacity of Opaganib for COVID-19
RedHill adds two more manufacturing partners, both U.S.-based, for large-scale manufacturing of opaganib, in preparation for potential emergency use applications as early as Q1/2021   The new collaborations follow recently announced collaborations with European and Canadian manufacturers   U.S. ...
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Toggle Summary RedHill Biopharma to Present at Evercore ISI HealthCONx and Piper Sandler Healthcare Conferences
TEL AVIV, Israel and RALEIGH, N.C. , Nov. 23, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present and participate at the following virtual conferences in December: Evercore ISI 3 rd ...
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Toggle Summary RedHill Biopharma Initiates Phase 3 Study of RHB-204 for First-Line Treatment of NTM Disease
RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line therapy   The Phase 3 study is expected to recruit up to 125 patients across approximately 40 U.S. ...
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Toggle Summary RedHill Announces Unanimous DSMB Recommendation to Continue Phase 2/3 COVID-19 Study with Opaganib
Pre-scheduled independent Data and Safety Monitoring Board (DSMB) unanimously recommends continuation of the global Phase 2/3 study of orally administered opaganib in severe COVID-19 pneumonia   Enrollment in the 270-patient global Phase 2/3 COVID-19 study with opaganib is more than 50% complete   ...
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Toggle Summary RedHill Biopharma's Second COVID-19 Candidate, RHB-107, Cleared by FDA for Phase 2/3 Study in Symptomatic COVID-19 Disease
FDA clears IND application for Phase 2/3 study with RedHill's second novel COVID-19 candidate, RHB-107 (upamostat), an orally administered novel serine protease inhibitor, with demonstrated antiviral and potential tissue-protective effects   The Phase 2/3 study is designed to evaluate ...
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