The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Anupam Rama - JPMorgan Chase & Co - Analyst
: Congrats on the approval. A quick one for me.
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OCTOBER 24, 2025 / 6:30PM, SNDX.OQ - Syndax Pharmaceuticals Inc to Discuss the FDA Approval of Revuforj
What does your market research suggest about the portion of patients that may have some baseline arrhythmia or something like that, where a
doc might have to think about using Revuforj and how physicians think about managing QTC prolongation as an AE for Revuforj?
And then, for the patient that had the fatal event that was highlighted in the label, (inaudible) -- can you remind us, is there anything to note in
that patient's baseline characteristics when considering the benefit -risk of Revuforj?
Question: Kevin Strang - Goldman Sachs Group Inc - Analyst
: This is Kevin, on for Corinne. Congrats on the approval.
I just wanted to follow up on that point. If you could just help us understand the change in the black boxed warning for QTC specifically and why
that was added on the back of this approval; and just reiterate what the implications are in your view, in terms of adoption in real-world practice.
Question: Peter Lawson - Barclays Services Corp - Analyst
: Congratulations on the approval.
Just to, continue the theme just around QT and Torsades, (inaudible) that change, in any way, (inaudible) what you can combine Revuforj with, the
particular standards of care, that also carry a cardio risk that could preclude any combinations?
Question: Peter Lawson - Barclays Services Corp - Analyst
: Got you. Are there any therapies that do have cardiotoxicity that we should be thinking about more thoroughly? FLT3?
Question: Ellen Horste, Ph.D. - Cowen and Company LLC - Analyst
: Congrats on the approval.
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OCTOBER 24, 2025 / 6:30PM, SNDX.OQ - Syndax Pharmaceuticals Inc to Discuss the FDA Approval of Revuforj
Just a question on comparing the labels across NPM1 and KMT2A. It looks like there are slightly increasing rates of Grade 5 and serious adverse
events across the board. I'm just wondering if this is correlated with increased exposure time to revumenib and whether this has any implications
for earlier line treatment.
Question: David Dai - UBS AG - Analyst
: Congrats on the approval.
On the fatal adverse reactions we're seeing with nine patients who were included in the label, now, we just see there's -- out of that nine, there's
four patients with certain death; whereas compared to last time, you only have one sudden death.
I just want to understand some detail around those three additional sudden deaths. Does that manifest in some of the characteristics of the NPM1
patients?
Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst
: Congrats on the approval. Three quick ones, clarifying.
When you say your launch can look different than the AML analogs, could you maybe just comment, do you mean the curve also versus maybe
the end market also that you mean?
And then, second question on the -- any protocol amendments being considered for the frontline trial? The one already ongoing? Or as you think
about the intensive chemo trial also starting?
Lastly, if you're able to preview the data in some way that you intend to have at ASH and then, later this year, just holistically, what we can learn
about the safety of the drug?
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