CLAIM #43559 · Merck & Company Inc (MRK) · 2025Q2 earnings call · Jul 29, 2025

“But my expectation in front of the data is I would imagine that the FDA would be interested in a Phase III trial to really demonstrate the effectiveness of this treatment in this broader patient population.”

Dean Li · President of Research Labs

How to check this claim

Look at: FDA requirement/agreement for a Phase III trial in the broader (non-PAH, PH-heart failure) patient population for this treatment

It came true if: Company or FDA discloses that a Phase III trial has been requested/required/initiated in this broader population

Where: Company press releases, clinicaltrials.gov filings, or management commentary on quarterly earnings calls

Knowable after: 2026-07-29

In context

“h heart failure. It's generally one that has hemodynamics that's a little bit more reminiscent of PAH than other diseases. And so we're really interested to study whether we can move out of PAH but focus on those who have heart failure and have a PH physiology. In terms of the outcomes, you're right, it's PVR, it's 6-minute. I would say probably the most important thing just because this is a patient population that's very different than a PAH population, the most important signal for me is really the PVR. I think the 6-minute walk will be also important. But to me, it's whether or not we can make a substantial impact on PVR in this patient population that is not PAH. In terms of this question of whether or not one would need to do a Phase III, I would say that we'll have to see the data. But my expectation in front of the data is I would imagine that the FDA would be interested in a Phase III trial to really demonstrate the effectiveness of this treatment in this broader patient population. Operator: Our next question comes from Vamil Divan with Guggenheim Securities. Vamil Kishore Divan: Maybe I'll just stick with WINREVAIR. One is actually a follow-up to the earlier question and then one question for myself. So just following up on the CADENCE discussion. I don't know if Dean or if someone could just maybe quantify the patient population. I know you mentioned patients maybe hemodynamically a little more skewed to what we've seen on the PAH side, but just a sense of the market size, it would be helpful because we've been getting a lot of questions on how to think about the opportunity. But my other question -- my main question is actually the ex U.S. uptake of WINREVAIR. There's just sort of a little bit of growth in the second quarter. I know you're just kind of getting go”

Verify independently

SEC filings for MRK ↗ · Quote is verbatim from the 2025Q2 earnings call.