Clinical EvidencePublished Phase 3 data showing strong safety, durable effectiveness and supporting secondary improvements strengthens the case for approval and increases prescriber confidence for broad use across mild, moderate and severe patients.
Commercial Readiness And Patient IdentificationAn exclusive specialty pharmacy agreement plus availability of a simple antibody finger‑prick test and expanded patient identification efforts improve launch preparedness and the potential to capture a larger addressable population.
Regulatory ProgressPriority Review request combined with a BLA resubmission using Fujifilm Diosynth Biotechnologies as drug substance manufacturer materially de‑risks the CMC package and supports a faster, more favorable regulatory outcome.