ODE Deep Dive: Reviewing 11 Cases for Insight into IPF (TPIP vs. Tyvaso)

Research evidence excerpt

ODE Deep Dive: Reviewing 11 Cases for Insight into IPF (TPIP vs. Tyvaso)

Equity Research

Multi Company Update — June 4, 2026

Biotechnology

ODE Deep Dive: Reviewing 11 Cases for Insight

into IPF (TPIP vs. Tyvaso)

INSM, UTHR

Our Call Benjamin Burnett, PhD

If Tyvaso gets ODE for IPF, will that block other treprostinil drugs? We review 11 successful Equity Analyst | Wells Fargo Securities, LLC

Benjamin.J.Burnett@wellsfargo.com | 212-214-5909

ODE cases, and see the likelihood for TPIP to navigate around a Tyvaso's ODE as not high (we

Tianqi Hang, PhDthink best way is through greater efficacy in a switch study).

Associate Equity Analyst | Wells Fargo Securities, LLC

Tianqi.Hang@wellsfargo.com | 212-214-5018

If Tyvaso gets ODE for IPF, does that impact the timing of a potential TPIP launch down Orfeas Sfyrlas

the road? To gain an edge here, we reviewed 11 past cases where FDA granted a new ODE Associate Equity Analyst | Wells Fargo Securities, LLC

notwithstanding existing ODE. Assuming TPIP is viewed as the same drug (we think likely Orfeas.Sfyrlas@wellsfargo.com | 646-425-2547

given the active is treprostinil), there are 3 ways superiority can be achieved: 1) greater

effectiveness, 2) greater safety, and 3) major contribution to patient care (MC-to-PC).

Within, we delve into successful cases in each category.

Prior ODE cases give us a sense for what's possible. The bar is highest for showing

superiority on efficacy, and generally requires comparative data (head-to-head is best).

Superiority on safety seems easier, and we found multiple cases where comparative data

weren't needed. MC-to-PC seems to afford the FDA with the greatest flexibility, though

we think the bar still seems high for purely convenience improvements, w/o any implied

safety benefit.