Abivax Faces Investigation After Troubling Phase 3 Trial Results

As previously reported, Wedbush upgraded Abivax to Neutral from Underperform with a price target of $90, down from $110. The firm notes the company reported placebo-adjusted maintenance clinical remission rates of 40% above its benchmark expectations of 20%-30%, but disclosed malignancies at the higher dose of 50 mg QD. Wedbush views these signals as increasing risk for an eventual black box warning, and prior to approval, an FDA AdComm, especially considering the novel proposed mechanism for obefazimod. Patients may need to remain on a riskier 50 mg dose long-term due to weaker long-term maintenance following de-escalation from 50 mg to 25 mg in a Phase 2 trial, the firm adds. On the positive side, Wedbush recognizes a top-line clinical remission rate of 50% for both 25 and 50 mg cohorts as offering potent monotherapy efficacy.