Prime Medicine said it will seek FDA approval for a previously shelved rare‑disease therapy after agency interactions signaled a regulatory environment for gene editing that may still be navigable. The company’s program uses prime editing, a CRISPR‑based method that can perform precise small‑scale DNA edits, and was administered to only two patients in an early human experience. Prime executives argue the agency’s recent rhetoric and evolving policy framework prompted a reassessment of the program’s clinical path. The planned filing will test FDA’s willingness to consider highly novel modalities with limited human exposure under accelerated or adaptive regulatory approaches. Prime’s move underscores the broader tension between innovation speed in cutting‑edge gene editing and regulators’ demands for robust evidence, especially when pivotal datasets are small.