RedHill Biopharma: Opaganib Fails To Meet Primary Endpoint In Phase 2/3 Study

RedHill Biopharma Ltd. (RDHL) reported preliminary top-line data from phase 2/3 study with opaganib in hospitalized patients with severe COVID-19 pneumonia. Preliminary top-line data showed that the study did not meet primary endpoint. Top-line safety data showed good tolerability of opaganib.

"While we are disappointed with the data not reaching statistical significance, we do see a trend that needs to be investigated that opaganib may provide benefit to patients earlier in the course of the disease," said Dror Ben Asher, RedHill CEO.

RedHill plans to discuss the data with regulators, including FDA and foreign regulators, to help determine next steps.

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