Clinical RiskThe VITESSE trial in peanut-allergic children (4–7 years) represents the last major clinical risk for Viaskin, with the Phase 3 trial fully enrolled and using a modified patch informed by previous studies.
Dependence On Trial SuccessSuccess in the upcoming Phase 3 VITESSE trial will satisfy requirements for the BLA submission, currently planned for H1 2026.
Market CompetitionOmalizumab biosimilars are expected to become widely available, which may reduce constraints on coverage/reimbursement of a branded agent.