Priority review

Also known as: priority review designation, priority review voucher, PRV

Priority review is an FDA designation that sets a 6-month goal for acting on a drug or biologic application, compared with 10 months under standard review. It goes to drugs that, if approved, would offer significant improvements in the safety or effectiveness of treating a serious condition.

How it works

The FDA decides whether to grant priority review when it accepts an NDA or BLA, within the 60-day filing period. For new molecular entities and original BLAs, the clock starts at the end of that filing period, so priority review means roughly 8 months from submission versus about 12 months for standard. The company typically announces the designation along with the PDUFA date.

Priority review only shortens the review clock. It does not lower the evidence bar, and the FDA still conducts inspections and may hold an advisory committee.

Priority review vouchers (PRVs) are a related tool. Sponsors can earn a voucher by winning approval in certain qualifying areas, such as tropical diseases or medical countermeasures, and redeem it to get priority review for a different application. Vouchers are transferable and have sold for tens of millions of dollars or more, so a sale is often material news for a small biotech.

Why it matters for traders

Priority review pulls the binary decision forward by about four months, which matters for cash runway and event timing. It also signals that the FDA views the drug as potentially significant. Voucher sales can provide non-dilutive cash that extends runway.

Example

Northwind Therapeutics (NWTX) submits a BLA on February 1. The FDA accepts it around April 1 with priority review, setting a PDUFA date around October 1, about 8 months from submission. Under standard review, the goal would have been around February 1 of the following year.

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Related terms

PDUFA dateThe target date by which the FDA aims to approve or reject a new drug or biologic application under the Prescription Drug User Fee Act.New Drug Application (NDA)The formal application a drugmaker submits to the FDA requesting approval to market a new small-molecule drug in the United States.Biologics License Application (BLA)The application a company submits to the FDA to market a biologic, such as an antibody, vaccine or gene therapy, in the United States.Breakthrough therapy designationAn FDA designation that speeds development of a drug for a serious condition when early clinical data show substantial improvement over existing therapy.Fast track designationAn FDA designation that speeds development of drugs for serious conditions with unmet need, adding FDA contact and rolling review of the application.Accelerated approvalAn FDA pathway approving drugs for serious conditions based on a surrogate endpoint, with confirmatory trials required to verify clinical benefit.

Part of the Quantisnow financial glossary. For longer explainers, see the investing guides. Educational content, not investment advice.