Regenxbio Gains Fresh Chance As FDA Reconsiders Gene Therapy

▤ Summary

Regenxbio gained a new path forward after the FDA said it will reconsider Navsunli for accelerated approval. The agency no longer requires additional patients, extra studies, or an untreated control arm before review. Regenxbio plans a Type A meeting in July and expects to resubmit its BLA in the third quarter of 2026. The decision follows the FDA’s earlier rejection in February and reflects a broader shift in how the agency handles rare-disease therapies.

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