Bavarian Nordic nets $160m from precedence assessment voucher sale

Precedence assessment vouchers are sometimes purchased by corporations seeking to dramatically scale back FDA assessment time for a brand new drug software. Credit score: Jack_the_sparow by way of Shutterstock.

Denmark-based Bavarian Nordic has bought a precedence assessment voucher (PRV) for $160m, a day after the US Meals and Drug Administration (FDA) introduced a brand new scheme utilising the fast-track tickets.

Bavarian Nordic didn’t disclose the client of the voucher, saying solely that the transaction is predicted to happen in Q3 2025. The vaccine specialist acknowledged its EBITDA might be positively impacted, with an replace occurring when the transaction closes.

The corporate is because of launch its Q2 2025 gross sales figures on 22 August, when it pronounces its half-year report. In Q1 2025, the biotech reported revenues of DKr1.35bn (roughly $195.4m), marking a 62% improve in comparison with the identical interval in 2024.

Based on Bavarian Nordic, the Nationwide Institutes of Well being (NIH) can even obtain 20% of the gross sales income beneath a licence settlement.

PRVs slash the FDA assessment time of a drug software from the same old ten months to 6 months. Firms creating a remedy for uncared for tropical illnesses, uncommon paediatric illnesses, or materials menace medical countermeasures are eligible to obtain one. Vouchers, that are given upon FDA approval of the drug in query, will be redeemed for any candidate in a pipeline or be bought, with charges decided by market dynamics.

Bavarian Nordic received its PRV when its chikungunya vaccine Vimkunya was authorised by the FDA in February 2025. Chikungunya, brought on by its namesake virus, is a mosquito-borne illness primarily present in tropical areas and is designated as a uncared for tropical illness. Vimkunya is the second authorised chikungunya vaccine within the US, with Valneva’s Ixchiq additionally on the market.

Sale figures growing after dip

PRVs had been launched in 2012 to incentivise improvement into non-lucrative illness areas. The report for the most costly PRV occurred in 2015 when AbbVie purchased a voucher from United Therapeutics for $350m. As per a GlobalData evaluation, offers have averaged round $100m in current instances as extra vouchers grew to become obtainable on the market.

Nonetheless, 2025 has seen an uptick in sale worth. Zevra Therapeutics bought one for $150m in February, with Abeona Therapeutics then offloading a voucher for $155m in Might. Mixed with Bavarian Nordic’s transaction, it appears the going fee for a PRV now hovers within the vary of $150m-$160m. It’s unclear why voucher costs have elevated, although the biotech funding drought and elevated impetus on sooner regulatory pathways are possible elements.

Yesterday [17 June], the FDA introduced a new PRV scheme known as the Commissioner’s Nationwide Precedence Voucher (CNPV) programme. This can shorten FDA assessment instances for a brand new drug software from 10-12 months to as much as two months. Pharma corporations must display US-centric potential for the drug to qualify for the brand new programme. Though it shares components of current PRV schemes, the standards to fulfill the CNPV programme necessities are considerably completely different. Critically, the vouchers within the CNPV programme should not allowed to be bought.

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