Abivax (ABVX) faces an increasing risk of black box warning for obefazimod due to malignancies reported from a recent trial, Wedbush Securities said in a Tuesday note.
The company said Monday that the phase 3 maintenance trial evaluating obefazimod in adults with moderately to severely active ulcerative colitis met its primary endpoint, with both 25 mg and 50 mg doses also achieving all key secondary endpoints.
Wedbush noted the seven malignancies reported in the trial's 50 mg cohort and one in the 25 mg, along with the novel proposed mechanism for obefazimod, as signals for an eventual black box warning. The brokerage also flagged this warning's potential negative impact on market share and marketing costs.
The possible regulatory and commercial delays could also pressure profitability based on obefazimod's patent life, Wedbush added, while noting obefazimod's potent monotherapy efficacy with a top-line clinical remission rate of 50% for both doses.
Wedbush Securities upgraded Abivax to neutral from underperform and cut its price target to $90 from $110.
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