The FDA selected the first nine recipients for its Commissioner’s National Priority Voucher (CNPV) pilot, allowing qualifying drug reviews to be fast‑tracked to a one- to two‑month window. The cohort includes investigational, foreign‑approved, and generic products addressing national priorities, signaling the agency will actively deploy the voucher to accelerate access for prioritized therapies. Markets reacted to specific inclusions: Disc Medicine, which submitted an NDA for bitopertin in erythropoietic protoporphyria, saw a notable share spike after the pick because the voucher materially improves the company’s odds of a 2025 approval. The agency’s selection criteria and the pilot’s broader policy implications are likely to reshape sponsor filing strategies and valuation models for late-stage programs addressing unmet needs.
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