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19 June 2025

Daily Newsletter

19 June 2025

Bavarian Nordic nets $160m from priority review voucher sale

Sale prices for the vouchers – which slash FDA review times for a drug – have increased in the past year as biotech funding dries up.

Robert Barrie June 18 2025

Denmark-based Bavarian Nordic has sold a priority review voucher (PRV) for $160m, a day after the US Food and Drug Administration (FDA) announced a new scheme utilising the fast-track tickets.

Bavarian Nordic did not disclose the buyer of the voucher, saying only that the transaction is expected to occur in Q3 2025. The vaccine specialist stated its EBITDA will be positively impacted, with an update occurring when the transaction closes.

The company is due to release its Q2 2025 sales figures on 22 August, when it announces its half-year report. In Q1 2025, the biotech reported revenues of DKr1.35bn (approximately $195.4m), marking a 62% increase compared to the same period in 2024.

According to Bavarian Nordic, the National Institutes of Health (NIH) will also receive 20% of the sales revenue under a licence agreement.

PRVs slash the FDA review time of a drug application from the usual ten months to six months. Companies developing a treatment for neglected tropical diseases, rare paediatric diseases, or material threat medical countermeasures are eligible to receive one. Vouchers, which are given upon FDA approval of the drug in question, can be redeemed for any candidate in a pipeline or be sold, with fees determined by market dynamics.

Bavarian Nordic won its PRV when its chikungunya vaccine Vimkunya was approved by the FDA in February 2025. Chikungunya, caused by its namesake virus, is a mosquito-borne disease mainly found in tropical regions and is designated as a neglected tropical disease. Vimkunya is the second approved chikungunya vaccine in the US, with Valneva’s Ixchiq also at the market.

Sale figures increasing after dip

PRVs were introduced in 2012 to incentivise development into non-lucrative disease areas. The record for the most expensive PRV occurred in 2015 when AbbVie bought a voucher from United Therapeutics for $350m. As per a GlobalData analysis, deals have averaged around $100m in recent times as more vouchers became available for sale.

However, 2025 has seen an uptick in sale value. Zevra Therapeutics sold one for $150m in February, with Abeona Therapeutics then offloading a voucher for $155m in May. Combined with Bavarian Nordic’s transaction, it seems the going rate for a PRV now hovers in the range of $150m-$160m. It is unclear why voucher prices have increased, though the biotech funding drought and increased impetus on faster regulatory pathways are likely factors.

Yesterday [17 June], the FDA announced a new PRV scheme called the Commissioner’s National Priority Voucher (CNPV) programme. This will shorten FDA review times for a new drug application from 10-12 months to up to two months. Pharma companies need to demonstrate US-centric potential for the drug to qualify for the new programme. Although it shares elements of existing PRV schemes, the criteria to meet the CNPV programme requirements are significantly different. Critically, the vouchers in the CNPV programme are not allowed to be sold.

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