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August 7, 2025
Merck KGaA, Germany (not Merck & Co. U.S.) stated on their Q2 earnings call, that they sold a priority review voucher at the end of July. Unclear if it was the voucher they received in the SpringWorks Therapeutics acquisition or whether it was a prior voucher they had purchased.
August 6, 2025
Jazz Pharmaceuticals ($JAZZ) received FDA approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. With this approval they received a Rare Pediatric Disease Priority Review Voucher.
July 22, 2025
The U.S. FDA today now accepting applications for the Commissioner’s National Priority Voucher (CNPV) program. In the pilot phase of the Commissioner's National Priority Voucher program, FDA will seek statements of interest from companies who wish to participate.
June 26, 2025
Now disclosed via FTC posting, Regeneron Pharmaceuticals ($REGN) was the purchaser of Abeona Therapeutics ($ABEO) PRV.
June 18, 2025
Bavarian Nordic ($BAVA.CO) just announced that they have sold the Tropical Disease Priority Review Voucher they received in February 2025 for $160M; purchaser not disclosed. The chikungunya vaccine was originally developed by the National Institute of Allergy and Infectious Diseases and as a result the National Institutes of Health will receive 20% of the sale price.
June 17, 2025
The U.S. FDA today announced a Commissioner’s National Priority Voucher (CNPV) program. The ultimate goal of the program is ‘to bring more cures and meaningful treatments to the American public.’
The new CNPV program will:
There will be a limited number of vouchers issued in the first year to companies that are aligned with the national health priorities of:
Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives.
May 12, 2025
Abeona Therapeutics Inc ($ABEO) announced today that they have entered into an agreement with an undisclosed buyer to sell their priority review voucher for $155 million. The PRV was awarded to Abeona in April 2025 in conjunction with the approval of Zevaskyn.
May 2, 2025
Novo Nordisk ($NVO) announced that the FDA has accepted its application for an oral version of Wegovy (semaglutide). While not specifically stated, the Q4 2025 PDUFA date implies a Priority Review Voucher was used for this submission.
April 29, 2025
Abeona Therapeutics Inc ($ABEO) received FDA approval today for Zevaskyn (prademagene zamikeracel) for wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. With this approval they received a Rare Pediatric Disease Priority Review Voucher.
April 28, 2025
Merck KGaA to Acquire SpringWorks Therapeutics for $3.4 Billion. Not specifically disclosed the value that was attributed to SpringWorks priority review voucher.
April 17, 2025
Regeneron Pharmaceuticals Inc $REGN redeems a priority review voucher for a supplemental Biologics License Application for EYLEA HD (aflibercept). The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications.
February 27, 2025
Zevra Therapeutics, Inc. $ZVRA announced today that they have entered into an agreement with an undisclosed buyer to sell their priority review voucher for $150 million. The PRV was awarded to Zevra in September 2024 in conjunction with the approval of Miplyffa.
February 14, 2025
Bavarian Nordic A/S $BAVA.CO was issued a Tropical Disease PRV following FDA approval of Vimkunya (chikungunya vaccine, recombinant) for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older.
February 12, 2025
U.S Congressman Michael McCaul (representing the 10th District of Texas) reintroduces the Give Kids a Chance Act that seeks to extend the FDA Rare Pediatric Disease Priority Review Voucher program to September 2029.
February 11, 2025
SpringWorks Therapeutics, Inc. $SWTX was issued a Rare Pediatric Disease PRV following FDA approval of Gomekli (mirdametinib) for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
January 31, 2025
Novartis $NVS stated at their Q4 earnings that they intend to use a PRV with their filing for remibrutinib in chronic spontaneous urticaria (CSU).
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