Beam Therapeutics and FDA agreed that biomarkers evaluated over a year could support an accelerated approval application for BEAM‑302, Beam’s base‑editing candidate for alpha‑1 antitrypsin deficiency (AATD). The alignment lets Beam pursue a biomarker‑based pathway—classic for accelerated approval—while planning confirmatory trials to validate clinical benefit. The agreement signals regulatory flexibility for in vivo gene‑editing programs and could accelerate timelines for first‑in‑class genetic medicines if surrogate markers reliably predict clinical outcomes. Beam’s move highlights how regulators and companies are negotiating evidence frameworks for DNA‑editing platforms.