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PRIORITY REVIEW VOUCHER WATCH
Tracking Priority Review Voucher issuances, sales, redemptions and the latest news.
Last updated 18 June 2025 - best viewed on desktop
This webpage has been compiled from manually reviewing thousands of documents from the U.S. Securities and Exchange Commission (SEC), U.S. Food and Drug Administrations (FDA), Federal Register and press releases to give a comprehensive overview of Priority Review Vouchers (PRVs) issued by the FDA. The information below is from publicly available sources only and does not include any undisclosed PRV issuance's, transactions or redemptions.
Background
The FDA established the Priority Review Voucher (PRV) program to incentivise drug development for
A sponsor who receives approval for a drug or biological product under one of these programs may qualify for a PRV. This may in turn be used by the sponsor who receives it, or sold to another sponsor who may then use it, to obtain priority review for a product application that would otherwise not receive priority review. A PRV thereby enables a product developer to potentially bring a product to market sooner than it would have under the standard review time.
On June 17th 2025, the FDA today announced a Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans.
The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission. There will be a limited number of vouchers issued in the first year to companies that are aligned with the national health priorities of:
Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives. The vouchers are not transferable but are retained if the company is acquired by another company and must be redeemed within 2 years.
Summary
No. of PRVs
issued
No. of publicly
disclosed PRV sales
86
86
65
65
No. of PRVs
redeemed
No. of PRVs with
unknown status
53
53
33
33
Highest reported
PRV sale price
Last reported
PRV sale price
$350,000,000
$350,000,000
$160,000,000
$160,000,000
There are no rows in this table
PRVs Issued
No. of PRVs issued by year
Type issued
Issued from NDAs/BLAs
PRVs issued in the last 12m
Approved
Company
Product
PRV
PRV Status
Sep 2024
IntraBio, Inc.
Aqneursa
RPD
unknown
Sep 2024
Zevra Therapeutics, Inc.
Miplyffa
RPD
SOLD
Nov 2024
PTC Therapeutics, Inc.
Kebilidi
RPD
SOLD
Dec 2024
Neurocrine Biosciences, Inc.
Crenessity
RPD
unknown
Dec 2024
Novo Nordisk Inc.
Alhemo
RPD
unknown
Jan 2025
SpringWorks Therapeutics, Inc.
Gomekli
RPD
unknown
Feb 2025
Bavarian Nordic A/S
Vimkunya
TD
SOLD
Apr 2025
Abeona Therapeutics Inc
Zevaskyn
RPD
SOLD
No results from filter
PRV Status: Redeemed - voucher was used by the original company the voucher was awarded to. Sold - voucher was sold onwards, vouchers may have been subsequently redeemed. Unknown - no public disclosure relating to this specific voucher.
PRVs sold over time (USD)
Only publicly disclosed prices shown. Where an exact date is not disclosed, the data point is marked at the last quarter of the reported time period. E.g if a sale/acquisition occurred in 2019 but no specified date given, this has been attributed to 2019 Q4.
PRVs Redeemed
Redeemed for new/supplemental applications by year
Redeemed for new/supplemental applications
Redeemed by disease area
Suggested citation
PRV Watch. (2025). Priority Review Voucher Watch. Website: https://www.prvwatch.com
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