PRV Watch

It’s rare for me to see a PRV acquisition and think why did they do that, this is one of those. I’ll be investigating probably too much than I should be over the next few days 🕵️‍♂️. Likely the next topic of my circular, I’ve had writers block for a while.

BioNTech $BNTX purchase Scholar Rock’s $SRRK Priority Review Voucher that they earned a couple of months ago for $205M

Quite stark when plotted like this, $2.2B in reported Priority Review Voucher sales so far in 2026, more than double any year prior.

$2.2 Billion in total Priority Review Voucher sales so far this year. 🤯

Cabaletta Bio $CABA plan to submit a BLA for their CAR-T in adult myositis in Q1 2028 but also intend to include data from their Ph1/2 trial in pediatric myositis to try and get a rare pediatric priority review voucher upon approval. It's creative but I don't think they should be eligible for a PRV this way.

One of the points in the legislation is that the application "does not seek approval for an adult indication in the original rare pediatric disease product application". There have been a few precedent setting approvals for PRVs in the last few years so I cant be sure here that they wouldn't be PRV eligible, perhaps arguing that these are two distinct indications and just happen to be filing together is a PRV-eligible approach 🤷‍♂️.

Very interested to see how the FDA handles this one, a PRV issuance here could set the precedent and direction for how other companies approach their trial sequencing and development plan. I can think of at least one other company off-hand that would immediately change their filing approach for their asset if this approach works in getting a PRV.