CLAIM #43666 · Merck & Company Inc (MRK) · 2026Q1 earnings call · Apr 30, 2026 · due Dec 31, 2026
“I would imagine that our estimation that we could get an approval at the second half of this year I see no reason to doubt that at this moment in time.”
Dean Li · President of Research Labs
How to check this claim
Look at: FDA approval status for the drug/program under discussion (CMPD program)
It came true if: FDA approval granted (or announced) between 2026-07-01 and 2026-12-31
Where: Company press release or FDA.gov approval announcement
In context
“of that sort of rolling submission, that's when the FDA sits there and gives you a letter and a PDUFA date. And so we are actively in those discussions with the FDA. And then as we normally do when we get formal acceptance of the complete file, which is a little bit different in the CMPB we'll make an announcement. I will emphasize that in our discussion with the FDA, -- what is very important to them is us really showing them that the CMPD program is important that we're addressing an important U.S. public health crisis that we're delivering innovative cures and we're increasing domestic drug manufacturer and supply chain resilient. So those are all important to the FDA, and we are in really good conversations with them. And so I think that is going quite well, and it's progressing well. I would imagine that our estimation that we could get an approval at the second half of this year I see no reason to doubt that at this moment in time. In relationship to what you said in relationship to this issue of how you would take it -- we're also in the discussion with the FDA as to what the exact label is in relationship to how they will talk about prescriptions and when to take it and how to take it. And I don't want to get ahead of that conversation because those are extremely active conversations as we speak. Operator: Our next question comes from Chris Schott with JPMorgan. Christopher Schott: I just wanted to touch base on TL1A I think this one's got maybe a little bit less attention than some of your other late-stage readouts this year. But can you just talk a little bit about the role you're seeing TL1A playing in the IBD space? And maybe more broadly, when we think about immunology and IBD, there does seem to be more disc”
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SEC filings for MRK ↗ · Claim quote is verbatim from the 2026Q1 earnings call.