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PRIORITY REVIEW VOUCHER WATCH
Tracking FDA Priority Review Voucher issuances, sales, redemptions and the latest news.
Last updated 13 September 2025 - best viewed on desktop
Background
The FDA Priority Review Voucher (PRV) programs incentivise drug development for:
The company who receives a PRV may redeem the voucher to obtain priority review for a product application that would otherwise not receive priority review. PRVs can also be sold or transferred between different companies.
Summary Statistics
No. of PRVs
issued
No. of publicly
disclosed PRV sales
87
87
71
71
No. of PRVs
redeemed
No. of PRVs with
unknown status
53
53
34
34
Highest reported
PRV sale price
Last reported
PRV sale price
$350,000,000
$350,000,000
$160,000,000
$160,000,000
There are no rows in this table
July 2025: Complete Response Letters Published |
June 2025: FDA Commissioner’s National Priority Voucher program
17 June 2025, the FDA announced a Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans.
The voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission. There will be a limited number of vouchers issued in the first year to companies that are aligned with the national health priorities of:
Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives. The vouchers are not transferable but are retained if the company is acquired by another company and must be redeemed within 2 years.
PRVs Issued
No. of PRVs issued by year
PRVs issued by type
Issued from NDAs/BLAs
PRVs issued <12m
Approved
Company
Product
PRV
PRV Status
Nov 2024
PTC Therapeutics, Inc.
Kebilidi
RPD
SOLD
Dec 2024
Neurocrine Biosciences, Inc.
Crenessity
RPD
unknown
Dec 2024
Novo Nordisk Inc.
Alhemo
RPD
unknown
Jan 2025
SpringWorks Therapeutics, Inc.
Gomekli
RPD
SOLD
Feb 2025
Bavarian Nordic A/S
Vimkunya
TD
SOLD
Apr 2025
Abeona Therapeutics Inc
Zevaskyn
RPD
SOLD
Aug 2025
Jazz Pharmaceuticals PLC
Modeyso
RPD
unknown
No results from filter
PRV Status: Redeemed - voucher was used by the original company the voucher was awarded to. Sold - voucher was sold onwards, vouchers may have been subsequently redeemed. Unknown - no public disclosure relating to this specific voucher.
PRV sales over time ($USD)
Only publicly disclosed prices shown.PRVs have been sold with no price disclosed. PRVs were transferred/sold to another company following prior licensing agreement.
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.
14
4
PRVs Redeemed
PRVs redeemed by year
Redeemed for application type
Redeemed by disease area
Follow
FDA Review Timelines
Comparing PRV Programs
Q2 2025 Summary
Citation
PRV Watch. (2025). Priority Review Voucher Watch. Website: https://www.prvwatch.com
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 an overview of FDA Priority Review Vouchers (PRVs). The information on this page is from publicly available sources only and does not include any undisclosed PRV issuance's, transactions or redemptions.
Copyright © 2025 PRV Watch
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