Beam Therapeutics said the FDA accepted a biomarker‑based accelerated‑approval approach for BEAM‑302, its base‑editing therapy for alpha‑1 antitrypsin deficiency (AATD). Regulators agreed that validated biomarkers assessed over one year could support an accelerated filing, with confirmatory outcomes required post‑approval. Beam plans to leverage functional biomarkers and a liver‑targeted LNP delivery to pursue a faster regulatory path. CEO John Evans highlighted the decision as a confirmation of FDA flexibility for genetic medicines. The agreement reduces a significant regulatory binary for in‑vivo base editing therapies and may set a precedent for other gene‑editing developers pursuing biomarker endpoints to gain earlier approvals.