BridgeBio's recently announced sale of an FDA Priority Review Voucher for
PRVs arose as a Congressionally authorized incentive for drug companies to develop treatments for tropical and rare pediatric diseases, and for medical countermeasures against chemical, biological, radiological, and nuclear threats. When the FDA approves a sponsor's drug in one of these three areas, it awards the sponsor a PRV. The PRV, which is transferrable, can later be redeemed by the PRV holder to claim a priority review of an NDA or BLA by the FDA, which targets a six-month turnaround instead of the standard ten months. The benefit of such expedited review, as described in the
Since the first PRV was awarded by the FDA in 2009, fewer than three dozen PRVs have been issued in total, most recently to COVID-19 vaccine applicants. Over the course of the program, the prices paid for PRVs have fluctuated widely. The high water mark appears to have been
Given the many factors that influence sellers' and buyers' assessments of value, PRV prices are likely to continue to fluctuate despite their limited supply. From the purchaser's perspective, the perception of value is largely based on the product the PRV will be used for. If that product has a large addressable market and there is an opportunity to beat competitors' therapies to the market, a head start could have significant value. From the seller's perspective, a sale may represent an opportunity to monetize a non-core asset, raising the capital needed to advance its own drug development programs. In a challenging capital markets environment, a PRV sale for cash upfront may be an attractive option for sustaining cash runway.
Transaction Reflects Healthy Market for FDA Priority Review Vouchers
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