UniQure disclosed that the FDA has signaled the company’s Phase I/II data for AMT‑130 may not be adequate to support a Biologics License Application, marking a reversal from prior agency communications. The company said the pre‑BLA meeting outcome means the timing of a U.S. submission is now unclear and that it will urgently seek clarity from regulators. The agency’s change follows September trial readouts that showed a large slowing of Huntington’s disease progression in treated patients. UniQure cited earlier guidance and prespecified analysis plans that it believed supported an accelerated approval pathway; the FDA’s current stance contrasts with those prior interactions. Investors repriced the company immediately — shares plunged more than 60% on the news — underscoring how regulatory feedback can rapidly alter the commercial and financing outlook for gene therapy developers. UniQure said it will review the agency’s final minutes and continue discussions to find a path forward.