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Tuesday, September 22, 2020 1:24:32 PM
Sep. 22, 2020 1:10 PM ET|About: RedHill Biopharma Ltd. (RDHL)|By: Vandana Singh, SA News Editor
The Brazilian Health Regulatory Agency has signed off the ongoing global Phase 2/3 study of RedHill Biopharma' (RDHL +1.5%) opaganib, sphingosine kinase-2 selective inhibitor, in patients hospitalized with severe COVID-19 pneumonia.
The study has been in Brazil, Israel, U.K., Italy, Russia and Mexico, and is expected to enroll up to 270 patients requiring hospitalization and treatment with supplemental oxygen.
In parallel, U.S. Phase 2 study with opaganib in patients with severe COVID-19 pneumonia is ~75% enrolled, with enrollment set to be completed in the coming weeks. Recently, a pre-scheduled independent Safety Monitoring Committee recommended that the study continue without change.
Recent RDHL News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/18/2024 01:00:09 PM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/03/2024 11:03:23 AM
- New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality • PR Newswire (US) • 09/03/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/29/2024 11:07:16 AM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/26/2024 11:02:21 AM
- RedHill's Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma • PR Newswire (US) • 08/26/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/21/2024 11:04:32 AM
- Talicia® Launched in the United Arab Emirates • PR Newswire (US) • 08/21/2024 11:00:00 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/20/2024 04:15:08 AM
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- RedHill Announces Positive Obesity and Diabetes Results with Opaganib • PR Newswire (US) • 08/19/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/16/2024 11:13:47 AM
- RedHill Biopharma Announces Plan to Implement ADS Ratio Change • PR Newswire (US) • 08/16/2024 11:00:00 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/13/2024 05:37:51 PM
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- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/07/2024 01:51:39 PM
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