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FDA Approves RedHill's COVID-19 Clinical Study With Opaganib; Stock Up 9%

Shares of RedHill Biopharma Ltd. (RDHL) are moving up over 9% in pre-market today, after the company announced that the U.S. FDA has approved its Investigational New Drug or IND application for a Phase 2a clinical study evaluating its investigational drug, opaganib, in patients with confirmed moderate-to-severe SARS-CoV-2 infection, the cause of COVID-19.

Mark Levitt, Medical Director at RedHill, said, "We are grateful to the FDA for the timely review of our IND and look forward to initiating the study. There is a strong scientific rationale for the potential efficacy of opaganib in the treatment of COVID-19, including pre-clinical data demonstrating that opaganib may inhibit viral replication and reduce levels of IL-6 and TNF-alpha, important mediators of inflammation that are elevated in moderate-to-severe COVID-19 patients."

"This is coupled with encouraging preliminary data from the compassionate use program in Israel, which demonstrated objective measurable clinical improvement in all six patients analyzed, including a decrease in required supplemental oxygenation, higher lymphocyte counts, and decreased CRP levels," Levitt added.

The stock has been trading between $3.26 and $9.12 for the past one year, and closed Thursday's trade at $6.54, down 1 cent or 0.15%. RDHL is currently trading at $7.16, up 62 cents or 9.48% in the pre-market session.

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