BioMarin withdrew its hemophilia A gene therapy Roctavian from the market after failing to secure a buyer or partner to shoulder commercial and reimbursement risk. The decision follows public scrutiny of gene therapy pricing, earlier proposals such as money‑back guarantees for insurers, and market reluctance to assume long‑term performance and cost obligations. BioMarin’s move underscores commercial headwinds facing ex‑U.S. and U.S. gene therapies where durable efficacy, payer contracting, and long‑term outcomes determine viability. The withdrawal raises questions about sustainable business models for one‑time curative therapies and the willingness of purchasers to underwrite uncertain long‑term value. Stakeholders now face a broader discussion about risk‑sharing, performance guarantees, and policy frameworks needed to support the gene therapy sector.