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PRIORITY REVIEW VOUCHER WATCH

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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 13, 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 Paediatric Disease Priority Review Voucher program to September 2029.

February 11, 2025

SpringWorks Therapeutics, Inc. $SWTX was issued a Rare Paediatric Disease PRV following FDA approval of Gomekli (mirdametinib) for adult and paediatric 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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