IND for COVID-19 with Opaganib Submitted to the FDA by RedHill Biopharma
Redhill Biopharma Ltd. - American Depositary Shares (RDHL)
US:NASDAQ Investor Relations:
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Company Research
Source: GlobeNewswire
Proposed study intended to evaluate the safety and efficacy of opaganib in up to 60 patients hospitalized with positive SARS-CoV-2 infection and pneumonia in the U.S.--Opaganib’s unique mechanism of action has both anti-viral and anti-inflammatory activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations --RedHill preparing for potential ramp-up of manufacturing of opaganib TEL-AVIV, Israel and RALEIGH, N.C., April 17, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study its investigational drug, opaganib (Yeliva®, ABC294640)1, for the treatment of SARS-CoV-2 infection (COVID-19). The IND submission follows preliminary discussions with the FDA on the study design. The proposed randomized, double-blind, place
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