PRIORITY REVIEW VOUCHER WATCH

Tracking FDA Priority Review Voucher issuances, sales, redemptions and the latest news.

Last updated 17 October 2025 - best viewed on desktop

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Background

The FDA Priority voucher programs incentivise drug development and reward companies:

for treatments of rare pediatric diseases (RPD).

for prevention and treatment of certain tropical diseases (TD).

for prevention or treatment for material threat medical countermeasures (MTMC).

for treatments aligned with U.S national health priorities through the Commisioner’s National Priority Voucher (CNPV) program.

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RPD

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MTMC

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CNPV

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Summary Statistics

No. of vouchers issued

No. of publicly disclosed voucher sales

97 ⁠
`71`
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No. of vouchers redeemed

No. of vouchers with unknown/unused status

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`53`
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44

Highest reported PRV sale price

Last reported PRV sale price

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`$350,000,000`
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`$160,000,000`
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There are no rows in this table

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Oct 2025: FDA Commissioner’s National Priority Voucher program

16 October 2025, the U.S. Food and Drug Administration today announced NINE voucher recipients under the new CNPV pilot program.

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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.

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FDA CNPV

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Jul 2025: Complete Response Letters Published
CRL Dashboard
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Search, summarize and download CRLs with this custom GPT

CRL GPT

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Priority vouchers issued

Vouchers issued by year

Vouchers issued by year

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Voucher type issued

Voucher type issued

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RPD, TD, or MTMC priority review vouchers (PRV) may be redeemed 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.

A CNPV, may be redeemed to reduce the timelines for FDA review from approximately 10-12 months to 1-2 months. These vouchers cannot be sold or transferred to another company and must be redeemed within 2 years.

Vouchers issued <12m

Vouchers issued <12m

Approved

Company

Product

Voucher

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

Sep 2025

Stealth BioTherapeutics

Forzinity

Oct 2025

EMD Serono

pergoveris

Oct 2025

Sanofi

teplizumab

Oct 2025

Achieve Life Sciences

cytisinicline

Oct 2025

Regeneron

DB-OTO

Oct 2025

Dompé

cenegermin-bkbj

Oct 2025

Revolution Medicines

RMC-6236

Oct 2025

Disc Medicine

bitopertin

Oct 2025

Phlow

ketamine

Oct 2025

USAntibiotics

Augmentin XR

No results from filter

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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. Unused - voucher not redeemed.

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PRV sales over time ($USD)

PRV sales over time ($USD)

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Only publicly disclosed prices shown.

14

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PRVs have been sold with no price disclosed.

4

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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.

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PRVs Redeemed

PRVs redeemed by year

PRVs redeemed by year

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Redeemed for application type

Redeemed for application type

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Redeemed by disease area

Redeemed by disease area

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Follow
PRVWatch
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FDA Review Timelines

FDA Review Timelines

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CNPV Recipients

CNPV Recipients

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Voucher Comparisons

Voucher Comparisons

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Citation

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

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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.

Background

Summary Statistics

Oct 2025: FDA Commissioner’s National Priority Voucher program

Jul 2025: Complete Response Letters Published CRL Dashboard

Priority vouchers issued

Vouchers issued by year

Voucher type issued

Vouchers issued <12m

PRV sales over time ($USD)

PRVs Redeemed

PRVs redeemed by year

Redeemed for application type