PRV Watch

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

[PRV Watch @PRVWatch]

@AlecGaffney FYI, think we were both questioning this at the time of Tzield approval.

[PRV Watch @PRVWatch]

GSK's Jemperli gets approval under the FDA Commissioner's National Priority Voucher program. FDA stated this was the 11th approval under the program but 12 of the drugs awarded have been approved. This confirms to me the Tzield approval from June wasn't actually via the program.

[PRV Watch @PRVWatch]

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.

[PRV Watch @PRVWatch]

I’m always interested in why companies use Priority Review Vouchers. One reason, is not giving your competition an edge. Seeing this play out in the Multiple Sclerosis oral BTKi space. Roche used one for their recent filing and Novartis will for theirs too.

[PRV Watch @PRVWatch]

@citrini Currently in the biology camp over the AI camp. Not because AI can’t accelerate R&D but because we just don’t have a good enough understanding yet (dataset) of the biology to do all of this in silico. But I’m all for the USDBillions being pumped into research by the AI labs.

[PRV Watch @PRVWatch]

@1000cures New branding looks great

[PRV Watch @PRVWatch]

Theranos value preposition from their 2006 pitchdeck. Removing black boxes is wild 😳

[Dan Primack @danprimack]

Artifact: On the day we launched Axios, I published a Theranos pitchdeck from 2006.

https://t.co/D9gprULzM8

[PRV Watch @PRVWatch]

The comparison of Dave’s tweets and CEOs from other companies is stark. You can tell his are true thoughts vs corporate messages undergone 10 revisions.

[Dave A Ricks @DaveARicks]

One month (or so) on @X , a platform unlike any other. Energy, speed, smarts and stupidity.
-The best thing in BioX - Rapid and divergent takes on new clinical data, on balance usually right..wisdom of crowds
-The worst thing on BioX - Shameless replies and reposts pumping your own book, praying for M&A about your favorite name, plane stalking…do people actually think this is how a real drug company or serious investor makes decisions? Maybe it just makes you feel like you have some agency, then ok.

[PRV Watch @PRVWatch]

Pro dashboards almost there v0.5.
(demo with dummy data)

[PRV Watch @PRVWatch]

Looking back at my poll from January, wonder what the peak will be this year, still a few months left.

[PRV Watch @PRVWatch]

How high do you think Priority Review Voucher prices will go in 2026?

[PRV Watch @PRVWatch]

Just a week later, Ultragenyx $RARE sell their second Priority Review Voucher for $203M

[PRV Watch @PRVWatch]

Ultragenyx $RARE sell their PRV for $210M, PRV prices holding strong

[PRV Watch @PRVWatch]

Inspired by @dave_ridley’s recent paper in Nature on the value of accelerating drug approvals, I’ve added an analysis (purple line) using my dataset to the chart. It suggests a trend that the number of PRVs available for sale is a key driver of PRV prices.

[PRV Watch @PRVWatch]

Eli Lilly's $LLY retatrutide estimate filing is Q1 2027. Will the FDA give them a Commissioner's National Priority Voucher to expedite approval?

[PRV Watch @PRVWatch]

and they still have another PRV they can monetize

[PRV Watch @PRVWatch]

Ultragenyx $RARE sell their PRV for $210M, PRV prices holding strong

[PRV Watch @PRVWatch]

Pro dashboards coming along v0.2

[PRV Watch @PRVWatch]

Interesting approach, commitment to returning 25% of a potential future PRV sale directly to shareholders.

[Atossa Therapeutics @atossainc]

Atossa Therapeutics Announces Plan to Issue Stapled CVR for Shareholders Tied to Potential Rare Pediatric Disease Priority Review Voucher.

Read more: https://t.co/4ArIvY63dH $ATOS

[PRV Watch @PRVWatch]

The 5th rare disease priority review voucher issued THIS MONTH!!

[PRV Watch @PRVWatch]

Egetis Therapeutics receives FDA approval today for Emcitate (tiratricol) to treat peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome. With this approval Egetis is awarded a Rare Pediatric Disease Priority Review Voucher.

[PRV Watch @PRVWatch]

Egetis Therapeutics receives FDA approval today for Emcitate (tiratricol) to treat peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome. With this approval Egetis is awarded a Rare Pediatric Disease Priority Review Voucher.

[PRV Watch @PRVWatch]

See a lot of press releases from tiny biotechs touting their assets future eligibility for a priority review voucher. Almost all still quote >$100M as market value for a PRV. Are they not tracking the PRV market, surely mentioning >$200M is more attractive.

[PRV Watch @PRVWatch]

Attended a talk about carbon credits today, a lot of parallels weirdly with the priority review voucher program.
- without financial incentive, companies wouldn’t address the need
- the concept has led to new companies forming to capitalize
- traded between companies and available supply dictates price
- smaller companies create and large ones buy for commercial benefit