Approval TimelineSuccess in the upcoming Phase 3 VITESSE trial will satisfy requirements for the BLA submission, currently planned for H1 2026.
Clinical RiskThe VITESSE trial in peanut-allergic children represents the last major clinical risk for the Viaskin Peanut program and is fully enrolled with a design informed by prior studies.
CompetitionOmalizumab biosimilars are expected to become widely available, which may reduce constraints on coverage/reimbursement of a branded agent.