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’.

In NYC next week if anyone is about. DM

It’s been a very active Q2 so far for Priority Review Voucher sales

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.

7 Priority Review Vouchers have been issued so far in 2026 and 5 of them have already been sold.

Immedica Pharma announced today that it has sold the priority review voucher they received in Feb for $200M . the PRV market is hot 🔥

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/drugsatfd…

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?

In the last 10 days there have been three Priority Review Voucher sales disclosed .... $180M, $195M and $187.5M

....and the product gets approval today.

$PRME Prime Medicine released their Q1 results today. No new update on their plans to file a BLA for PM359, an ex vivo prime-edited autologous stem cell therapy for Chronic Granulomatous Disease. Prime was originally going to seek approval using the plausible mechanism pathway following positive proof-of-concept data from two patients treated in its Phase 1/2 study. Those patients were 18 and 57 years old. I think they’ll delay filing to recruit one more patient that is <18years to then be eligible for a Rare Pediatric Disease Priority Review Voucher upon approval.

Commissioner's National Priority Voucher issued to Bizengri (zenocutuzumab-zbco) for advanced unresectable or metastatic cholangiocarcinoma. Partner Therapeutics announced on April 14th that they had already submitted the sBLA for this indication so decision expected soon.

Here’s my previous thread explaining the history of the Sezaby approval, PRV denial and their success in overturning the decision.

Sun Pharma announced today that they have sold their Priority Review Voucher for $195M . They were issued the PRV this year for Sezaby after successfully suing the FDA for being denied the voucher in 2022.