Prime Medicine has reversed an earlier decision to shelve a gene‑editing program and will seek FDA approval for a prime‑editing therapy after treating only two patients, according to company statements and STAT reporting. The therapy uses prime editing, a CRISPR‑based tool developed by David Liu’s lab, to correct a small DNA defect in blood cells for a rare immune disease. The company says it will file with the FDA despite extremely limited clinical exposure; regulators have signaled both willingness to accelerate gene‑editing reviews and increased scrutiny of small, early datasets. The development tests how regulators apply flexible pathways for first‑in‑class genome‑editing treatments while balancing patient safety and evidentiary standards.