Beam Therapeutics and the FDA agreed that biomarker changes assessed over one year could support an accelerated approval pathway for Beam’s BEAM‑302 base‑editing candidate for alpha‑1 antitrypsin deficiency (AATD), Beam reported. The alignment lets Beam pursue a biomarker‑based registration strategy—using surrogate endpoints that predict clinical benefit—to shorten time to market while planning confirmatory trials. BEAM‑302 uses liver‑targeted lipid nanoparticle delivery of a base editor to correct the PiZ mutation in SERPINA1. The FDA’s acceptance of a biomarker‑driven approach is notable because it signals regulator willingness to consider molecular surrogate endpoints for certain in vivo gene‑editing therapies. For context, accelerated approval allows earlier patient access based on a surrogate reasonably likely to predict clinical benefit, with post‑approval confirmation required. Investors lifted Beam’s stock on the news. The decision may influence development strategies for other gene editing programs seeking faster paths to approval while balancing confirmatory evidence obligations.