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PRIORITY REVIEW VOUCHER WATCH

Tracking Priority Review Voucher issuances, sales, redemptions and the latest news.
Last updated 12 May 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
prevention and treatment of certain tropical diseases (TD).
rare pediatric diseases (RPD).
prevention or treatment for material threat medical countermeasures (MTMC).
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.

Summary

No. of PRVs issued
No. of publicly disclosed PRV sales

86

64

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

53

33

Highest reported PRV sale price
Last reported PRV sale price

$350,000,000

$155,000,000

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
Sep 2024
Zevra Therapeutics, Inc.
Miplyffa
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
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. 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

pen

Suggested citation

PRV Watch. (2025). Priority Review Voucher Watch. Website: https://www.prvwatch.com
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