7 Priority Review Voucher sales announced so far this year with the smaller biotechs opting to monetize their PRVs as soon as possible from it being issued. Prices between $180M - $200M holding strong.
Denali Therapeutics $DNLI announced today that they have sold the priority review voucher they were issued in March for $195M . Six of the Seven PRVs issued this year have been sold already, with the last to be likely retained by the company (Regeneron) to redeem themselves.
Sanofi $SNY receives approval for Tzield (teplizumab) to treat pediatric stage 3 T1D. Sanofi was awarded a Commissioner's National Priority Voucher for this indication but its unclear if this approval was still under the CNPV program as the decision has been delayed for months.
most people in biotech don't even know the PRV exists, but the data are there for anyone who's curious 📊👀
at the current clearing price of ~$200M, it now pays to invest in rare disease drug development
the demand for PRVs is going up because pharma is hungry for blockbusters
Commissioner’s National Priority Voucher public hearing underway. Spokesperson from @PhRMA asked in their statement to change the name to remove ‘voucher’ as it isn’t a tradable asset like the other voucher programs. I endorse this suggestion, I would make it a ‘designation’.
The Commissioner’s National Priority Voucher program has dramatically reduced FDA timelines for the two novel drugs approved within the program so far.
- Foundayo, an oral GLP-1 approved ~2.5 months after submission.
- Otarmeni, a gene therapy for genetic hearing loss approved ~4 months after submission.
$LLY Eli Lilly had planned to use a Priority Review Voucher (current value $200M) for its oral GLP-1 Foundayo to speed up FDA review. However, they were granted a Commissioner’s National Priority Voucher, enabling a faster approval while preserving its PRV for a future use.
Foundayo (orforglipron) was the first novel drug approved under the Commissioner's National Priority Voucher pilot program. The FDA review documents hadn't been published for a while but are now available. accessdata.fda.gov/drugsatfda_doc…
Marty Makary introduced the Commissioner's National Priority Voucher pilot program last year with 22 vouchers issued and 7 approvals under the program so far. Will the next FDA Commissioner continue to issue Commissioner National Priority Vouchers?
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