After Durect announced that it has reached agreement with the FDA for a single Phase 3 study to evaluate larsucosterol in 200 U.S.-enrolled patients with severe alcohol-associated hepatitis, or AH, with a primary endpoint focusing on 90- day mortality, Northland called this news “a major positive,” considering the about 60% mortality reduction exhibited in the U.S. subgroup population in the Phase 2 AHFIRM study, which accounted for 76% of enrollment in the trial. The compelling mortality reductions among the U.S. subgroup in the Phase 2b AHFIRM study “uniquely derisks larsucosterol’s development,” argues the analyst, who has an Outperform rating and $8.50 price target on Durect shares.
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