PRV Watch

Tracking FDA Priority Review Voucher (PRV) issuances, sales, redemptions and other FDA/Biotech news.

[PRV Watch @PRVWatch]

In NYC next week if anyone is about. DM

[PRV Watch @PRVWatch]

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

[PRV Watch @PRVWatch]

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.

[PRV Watch @PRVWatch]

$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.

[PRV Watch @PRVWatch]

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

[PRV Watch @PRVWatch]

@prosperousguy Not disclosed

[PRV Watch @PRVWatch]

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

[PRV Watch @PRVWatch]

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

[PRV Watch @PRVWatch]

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. https://t.co/hNRnrkYSZg

[PRV Watch @PRVWatch]

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?

[PRV Watch @PRVWatch]

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

[PRV Watch @PRVWatch]

@GeneInvesting When did they formal confirm this? last I saw was in an industry conference they mentioned consideration of it but hadn't seen a formal confirmation yet.

[PRV Watch @PRVWatch]

$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.

[PRV Watch @PRVWatch]

....and the product gets approval today.

[PRV Watch @PRVWatch]

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.

[PRV Watch @PRVWatch]

@AlecGaffney @LizzyLaw_ Not sure I agree in this context. The centre director is part of the CNPV council that votes on the drug. The centre director reviews the recommendation of the primary review team, the CNPV council and their own view to provide the final recommendation.

[PRV Watch @PRVWatch]

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.

[U.S. FDA @US_FDA]

A drug that treats an ultra-rare cancer that forms in the bile ducts, zenocutuzumab-zbco, has been granted the 22nd voucher under the FDA’s Commissioner’s National Priority Voucher pilot program.
https://t.co/IivUohU0I4

[PRV Watch @PRVWatch]

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

[PRV Watch @PRVWatch]

Sun Pharma was denied a Priority Review Voucher in 2022 following FDA approval of Sezaby (phenobarbital sodium) for neonatal seizures. They sued the FDA last year, and yesterday a court ruled in their favor. A brief history below (1/7)🧵👇

[PRV Watch @PRVWatch]

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.

[PRV Watch @PRVWatch]

Seen a big step up in FDA comms and content on social media over last few months. Kudos to whoever is behind @US_FDA

[PRV Watch @PRVWatch]

@idalopirdine Agreed but it’s the FDA they routinely have access to MNPI, why a specific concern for this pilot?