Link to page

PRIORITY REVIEW VOUCHER WATCH

Tracking FDA Priority Review Voucher issuances, sales, redemptions and the latest news.
Last updated 30 August 2025 - best viewed on desktop

Background

The FDA Priority Review Voucher (PRV) programs incentivise drug development for:
prevention and treatment of certain tropical diseases (TD).
rare pediatric diseases (RPD).
prevention or treatment for material threat medical countermeasures (MTMC).
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

71

No. of PRVs redeemed
No. of PRVs with unknown status

53

34

Highest reported PRV sale price
Last reported PRV sale price

$350,000,000

$160,000,000

There are no rows in this table

fda

July 2025: Complete Response Letters Published |

fda

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:
Addressing a health crisis in the U.S.
Delivering more innovative cures for the American people.
Addressing unmet public health needs.
Increasing domestic drug manufacturing as a national security issue.
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.
image.png

PRVs Issued

No. of PRVs issued by year
PRV type issued
Issued from NDAs/BLAs
PRVs issued in the last 12m
Approved
Company
Product
PRV
PRV Status
Nov 2024
PTC Therapeutics, Inc.
Kebilidi
Dec 2024
Neurocrine Biosciences, Inc.
Crenessity
Dec 2024
Novo Nordisk Inc.
Alhemo
Jan 2025
SpringWorks Therapeutics, Inc.
Gomekli
Feb 2025
Bavarian Nordic A/S
Vimkunya
Apr 2025
Abeona Therapeutics Inc
Zevaskyn
Aug 2025
Jazz Pharmaceuticals PLC
Modeyso
No results from filter
asterisk
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)
info
Only publicly disclosed prices shown.
14
PRVs have been sold with no price disclosed.
4
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.

PRVs Redeemed

No. of PRVs redeemed by year
Redeemed for application type
Redeemed by disease area
x2

Follow

Slide1.png
FDA Review Timelines
Slide1.png
Comparing PRV Programs
X Q SUMMARY2.gif
Q2 2025 Summary
pen

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

Want to print your doc?
This is not the way.
Try clicking the ⋯ next to your doc name or using a keyboard shortcut (
CtrlP
) instead.