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PRIORITY REVIEW VOUCHER WATCH
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PRIORITY REVIEW VOUCHER WATCH
best viewed on desktop browser - Last updated 27 February 2025
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
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
85
85
63
63
No. of PRVs
redeemed
No. of PRVs with
unknown status
49
49
36
36
Highest reported
PRV sale price
Last reported
PRV sale price
$350,000,000
$350,000,000
$150,000,000
There are no rows in this table
PRVs Issued
No. of PRVs issued by year
Type issued
Issued from NDAs/BLAs
View of List of PRVs issued
Approved
Company
Product
PRV
PRV Status
Apr 2009
Novartis AG
Coartem
TD
REDEEMED
Dec 2012
Johnson & Johnson
Sirturo
TD
REDEEMED
Feb 2014
BioMarin Pharmaceutical Inc.
Vimizim
RPD
SOLD
Mar 2014
Paladin Therapeutics, Inc.
Impavido
TD
SOLD
Mar 2015
Asklepion Pharmaceuticals, LLC
Cholbam
RPD
SOLD
Mar 2015
United Therapeutics Corporation
Unituxin
RPD
SOLD
Sep 2015
Wellstat Therapeutics Corporation
Xuriden
RPD
SOLD
Oct 2015
Alexion Pharmaceuticals, Inc.
Strensiq
RPD
REDEEMED
Dec 2015
Alexion Pharmaceuticals, Inc.
Kanuma
RPD
unknown
Jun 2016
PaxVax Bermuda Ltd.
Vaxchora
TD
SOLD
Sep 2016
Sarepta Therapeutics, Inc.
Exondys 51
RPD
SOLD
Dec 2016
Biogen Inc.
Spinraza
RPD
SOLD
Feb 2017
Marathon Pharmaceuticals, LLC
Emflaza
RPD
SOLD
Apr 2017
BioMarin Pharmaceutical Inc.
Brineura
RPD
SOLD
Aug 2017
Chemo Research, S.L.
benznidazole
TD
SOLD
Aug 2017
Novartis AG
Kymriah
RPD
unknown
Nov 2017
Ultragenyx Pharmaceutical Inc.
Mepsevii
RPD
SOLD
Dec 2017
Spark Therapeutics, Inc.
Luxturna
RPD
SOLD
Apr 2018
Ultragenyx Pharmaceutical Inc.
Crysvita
RPD
SOLD
Jun 2018
Medicines Development For Global Health
moxidectin
TD
SOLD
Jun 2018
GW Pharmaceuticals PLC
Epidiolex
RPD
SOLD
Jul 2018
SIGA Technologies, Inc.
Tpoxx
MTMC
SOLD
Jul 2018
GSK PLC
Krintafel
TD
REDEEMED
Oct 2018
Leadiant Biosciences, Inc.
Revcovi
RPD
unknown
Nov 2018
Novimmune S.A.
Gamifant
RPD
SOLD
Jan 2019
Vertex Pharmaceuticals Inc.
Symdeko
RPD
unknown
Feb 2019
Novartis AG
Egaten
TD
REDEEMED
May 2019
Sanofi
Dengvaxia
TD
unknown
May 2019
Novartis AG
Zolgensma
RPD
unknown
Aug 2019
Global Alliance for TB Drug Development
pretomanid
TD
SOLD
Sep 2019
Bavarian Nordic A/S
Jynneos
MTMC
SOLD
Oct 2019
Vertex Pharmaceuticals Inc.
Trikafta
RPD
unknown
Dec 2019
Merck & Co., Inc.
Ervebo
TD
SOLD
Dec 2019
Sarepta Therapeutics, Inc.
Vyondys 53
RPD
SOLD
Apr 2020
AstraZeneca PLC
Koselugo
RPD
unknown
May 2020
Amivas, Inc.
artesunate
TD
unknown
Aug 2020
Nippon Shinyaku Co., Ltd.
Viltepso
RPD
SOLD
Aug 2020
Genentech, Inc.
Evrysdi
RPD
REDEEMED
Aug 2020
Bayer AG
Lampit
TD
SOLD
Oct 2020
Regeneron Pharmaceuticals, Inc.
Inmazeb
MTMC
REDEEMED
Oct 2020
Gilead Sciences, Inc.
Veklury
MTMC
unknown
Nov 2020
Eiger BioPharmaceuticals, Inc.
Zokinvy
RPD
SOLD
Nov 2020
Y-mAbs Therapeutics, Inc.
Danyelza
RPD
SOLD
Nov 2020
Rhythm Pharmaceuticals, Inc.
Imcivree
RPD
SOLD
Nov 2020
Alnylam Pharmaceuticals, Inc.
Oxlumo
RPD
REDEEMED
Dec 2020
Ridgeback Biotherapeutics, LP
Ebanga
MTMC
unknown
Feb 2021
Sarepta Therapeutics, Inc.
Amondys 45
RPD
SOLD
Feb 2021
Origin Biosciences, Inc.
Nulibry
RPD
SOLD
Jun 2021
Mallinckrodt Pharmaceuticals
Stratagraft
MTMC
SOLD
Jun 2021
Prometic Biotherapeutics, Inc.
Ryplazim
RPD
SOLD
Jul 2021
Albireo AB
Bylvay
RPD
SOLD
Jul 2021
Sanofi / Drugs for Neglected Diseases initiative
fexinidazole
TD
unknown
Aug 2021
BioNTech SE
Comirnaty
MTMC
unknown
Sep 2021
Mirum Pharmaceuticals, Inc.
Livmarli
RPD
SOLD
Oct 2021
Enzyvant Therapeutics GmbH
Rethymic
RPD
unknown
Nov 2021
BioMarin Pharmaceutical Inc.
Voxzogo
RPD
SOLD
Jan 2022
Moderna, Inc.
Spikevax
MTMC
REDEEMED
Mar 2022
Marinus Pharmaceuticals, Inc.
Ztalmy
RPD
SOLD
Aug 2022
bluebird bio, Inc.
Zynteglo
RPD
SOLD
Aug 2022
Sanofi
Xenpozyme
RPD
unknown
Sep 2022
bluebird bio, Inc.
Skysona
RPD
SOLD
Feb 2023
Reata Pharmaceuticals, Inc.
Skyclarys
RPD
SOLD
Feb 2023
Chiesi Farmaceutici S.p.A
Lamzede
RPD
unknown
Mar 2023
Pharming Group N.V.
Joenja
RPD
SOLD
Mar 2023
Acadia Pharmaceuticals Inc.
Daybue
RPD
SOLD
May 2023
Pfizer Inc.
Paxlovid
MTMC
unknown
May 2023
Krystal Biotech, Inc.
Vyjuvek
RPD
SOLD
Jun 2023
Sarepta Therapeutics, Inc.
Elevidys
RPD
SOLD
Aug 2023
Ipsen S.A.
Sohonos
RPD
SOLD
Aug 2023
Regeneron Pharmaceuticals, Inc.
Veopoz
RPD
unknown
Nov 2023
Valneva SE
Ixchiq
TD
SOLD
Nov 2023
Takeda Pharmaceutical Co Ltd
Adzynma
RPD
unknown
Dec 2023
Chiesi Farmaceutici S.p.A
Filsuvez
RPD
unknown
Dec 2023
Vertex Pharmaceuticals Inc.
Casgevy
RPD
unknown
Mar 2024
Italfarmaco S.p.A.
Duvyzat
RPD
unknown
Mar 2024
Orchard Therapeutics PLC
Lenmeldy
RPD
unknown
Apr 2024
X4 Pharmaceuticals, Inc.
Xolremdi
RPD
SOLD
Apr 2024
Day One Biopharmaceuticals, Inc.
Ojemda
RPD
SOLD
Sep 2024
IntraBio, Inc.
Aqneursa
RPD
unknown
Sep 2024
Zevra Therapeutics, Inc.
Miplyffa
RPD
SOLD
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
unknown
Feb 2025
Bavarian Nordic A/S
Vimkunya
TD
unknown
No results from filter
PRV Status: Redeemed - indicates the voucher was used by the original company the voucher was awarded to. Sold - indicates the voucher was sold onwards, vouchers may have been subsequently redeemed. Unknown - no public disclosure relating to this specific voucher.
PRVs sold over time (USD)
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
Suggested citation
PRV Watch. (2025). Priority Review Voucher Watch. Website: https://www.prvwatch.com
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