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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 Commissioner’s National Priority Voucher (CNPV) program.
Zongertinib (Boehringer Ingelheim) for HER2 lung cancer Bedaquiline (Johnson & Johnson) for drug-resistant TB in young children Dostarlimab (GSK) for rectal cancer Casgevy (Vertex Pharmaceuticals) for sickle cell disease Orforglipron (Eli Lilly and Company) for obesity and related health conditions Wegovy (Novo Nordisk) for obesity and related health conditions
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.
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.
PRIORITY REVIEW VOUCHER WATCH
Tracking FDA Priority Review Voucher issuances, sales, redemptions and news.
Last updated 15 December 2025 - best viewed on desktop
Background
The FDA Priority voucher programs incentivise drug development and reward companies:
No. of vouchers
issued
No. of publicly
disclosed voucher sales
106
71
No. of vouchers
redeemed
No. of vouchers with
unknown/unused status
59
47
Highest reported
PRV sale price
Last reported
PRV sale price
$350,000,000
$175,000,000
There are no rows in this table
Key events:
Dec 2025: Give Kids a Chance Act passed in US Congress
The Mikaela Naylon Give Kids a Chance Act to reauthorize the rare pediatric disease priority review voucher program was passed in Congress. The Bill would extend the program to 2029.
The Bill is now required to be voted in the Senate before it passes on to the President and then becomes law.
Nov 2025: FDA Commissioner’s National Priority Voucher program
6 November 2025, the U.S. Food and Drug Administration today announced SIX more voucher recipients under the new CNPV pilot program.
16 October 2025, the U.S. Food and Drug Administration today announced NINE voucher recipients under the new CNPV pilot 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.
Jul 2025: Complete Response Letters Published
See our CRL Dashboard analysing all the CRLs realeased by the FDA Search, summarize and download CRLs with our custom GPT
Priority vouchers issued
Vouchers issued by year
Voucher type issued
Vouchers issued <12m
Approved
Company
Product
Voucher
Status
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
Sep 2025
Stealth BioTherapeutics
Forzinity
RPD
unknown
Oct 2025
EMD Serono
Pergoveris
CNPV
UNUSED
Oct 2025
Sanofi
Tzield
CNPV
REDEEMED
Oct 2025
Achieve Life Sciences
cytisinicline
CNPV
UNUSED
Oct 2025
Regeneron
DB-OTO
CNPV
UNUSED
Oct 2025
Dompé
Oxervate
CNPV
UNUSED
Oct 2025
Revolution Medicines
daraxonrasib
CNPV
UNUSED
Oct 2025
Disc Medicine
bitopertin
CNPV
REDEEMED
Oct 2025
Phlow
ketamine
CNPV
UNUSED
Oct 2025
USAntibiotics
Augmentin XR
CNPV
REDEEMED
Nov 2025
UCB
Kygevvi
RPD
unknown
Nov 2025
Boehringer Ingelheim
Hernexeos
CNPV
UNUSED
Nov 2025
Johnson & Johnson
Sirturo
CNPV
UNUSED
Nov 2025
GSK
Jemperli
CNPV
UNUSED
Nov 2025
Vertex Pharmaceuticals
Casgevy
CNPV
UNUSED
Nov 2025
Eli Lilly and Company
orforglipron
CNPV
UNUSED
Nov 2025
Novo Nordisk Inc.
Wegovy
CNPV
REDEEMED
Dec 2025
Fondazione Telethon ETS
Waskyra
RPD
unknown
Dec 2025
Johnson & Johnson
Tecvayli
CNPV
REDEEMED
No results from filter
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.
Commissioner’s National Priority Voucher (CNPV) tracker
Company
Product
Indication
Voucher
FDA filing/approval date
Pergoveris
Infertility
unused
Unknown filing date
Tzield
Stage 3 Type 1 diabetes
REDEEMED
Decision by Dec 20, 2025
cytisinicline
Nicotine vaping/e-cig addiction
unused
Est filing 2027
DB-OTO
Deafness (OTOF-related)
unused
Filing Q4 2025
Oxervate
Blindness (NAION)
unused
Unknown filing date
daraxonrasib
Pancreatic cancer (PDAC)
unused
Est filing 2026/2027
bitopertin
Erythropoietic Protoporphyria
REDEEMED
Decision by est Jan 28, 2026
ketamine
General anesthesia
unused
Unknown filing date
Augmentin XR
Bacterial infections
REDEEMED
Approved Dec 10th 2025
Hernexeos
1L HER2 advanced NSCLC
unused
Unknown filing date
Sirturo
Pediatric multi-drug resistant TB
unused
Est filing 2027
Jemperli
dMMR/MSI-H advanced rectal cancer
unused
Est filing 2026/2027
Casgevy
Pediatric severe sickle cell disease
unused
Filing H1 2026
orforglipron
Obesity
unused
Filing Q4 2025
Wegovy
7.2mg dose for obesity
REDEEMED
Decision by est Mar 26, 2026
Tecvayli
With Darzalex for r/r multiple myeloma
REDEEMED
Already submitted as of Dec 9
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PRVs sold over time (USD)
Only publicly disclosed prices shown. 13 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.
Priority vouchers redeemed
Vouchers redeemed by year
Redeemed by appl. type
CNPVs redeemed
Redeemed by disease area
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FDA Review Timelines
CNPV Recipients
Voucher Comparisons
Citation
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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