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: Priyanka Grover - JPMorgan - Analyst
: This is Priyanka on for Anupam. Congratulations on the amazing progress. Our question is, what are you seeing in regards to the repeat prescribers
for Revuforj? Are there certain centers of excellence that have a few high repeat prescribers? Or are those prescribers more spread out?
Question: Ellen Horste - TD Cowen - Analyst
: Congratulations on an awesome Q1. I'm wondering if you can share any color on the month-over-month trends for new patient adds for Revuforj
in Q1, as in with patient flow steady through the quarter? Did you see some acceleration throughout? And then can you share any details on the
free drug rate and whether you expect that to continue in Q2 and beyond?
Question: Ellen Horste - TD Cowen - Analyst
: Thank you.
Question: Peter Lawson - Barclays - Analyst
: I wonder if you could speak about any trends that you're seeing in GVHD, in particular, any of the subgroups.
Question: Peter Lawson - Barclays - Analyst
: Yes, yes, exactly. And then, if there's any kind of age differences between those that are getting it versus not. Any details there would be great.
Question: Michael Schmidt - Guggenheim Securities LLC - Analyst
: Congrats on the first quarter results. Could you just comment on to what degree off-label use in NPM1 patients may have contributed to 1Q Revuforj
sales? And then, yes, I had a clinical question also on the comments that were made around the change in the design of the EVOLVE-2 study where
you now have the CR endpoint included.
And could you just comment on how that may impact potential timing to completion of the trial? And it sounds like you may have had similar
discussions around the fit -- the planned studies in the fit patient populations as well. Just curious if you could share sort of the feedback that you've
received there from the agency.
Question: David Dai - UBS - Analyst
: Congrats on the quarter. I also just want to kind of focus on the EVOLVE-2 trial in the onset population. So I understand that you just got FDA buy-in
to use the dual primary endpoints. So I'm wondering if it's possible for you to provide some additional color around powering for the trial.
Question: Yigal Nochomovitz - Citi - Analyst
: I had a question on the strategy around the fit studies. Can you just elaborate as to why it seems like you're pursuing 2 separate trials for NPM1
and KMT2A versus in the unfit, it's all lumped together? Is there a specific reason for that? Or is that set in stone? Or is that something that's still
subject to discussion with the FDA?
Question: Yigal Nochomovitz - Citi - Analyst
: Okay. And also on the comments around the use of Revuforj and the transplant patients that you mentioned, I'm just curious, did some of those
-- did they achieve CR/CRh? Or are you seeing in the commercial setting that the physicians are willing to go to transplant before seeing CR/CRh
with Revuforj? I know that's quite detailed.
Question: Kalpit Patel - B. Riley Securities - Analyst
: Congrats on the net sales for both of these assets. I had a couple of questions for Revuforj. Do you have any color on what portion of the $20 million
revenue stemmed from refill dynamics from those fourth quarter patients versus new patient starts in the first quarter? And then, as a follow-up,
do you have an early sense of the median duration of therapy for those patients who were enrolled or treated in the fourth quarter?
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MAY 05, 2025 / 8:30PM, SNDX.OQ - Q1 2025 Syndax Pharmaceuticals Inc Earnings Call
Question: Kalpit Patel - B. Riley Securities - Analyst
: Median duration of therapy.
Question: Jeet Mukherjee - BTIG - Analyst
: Congrats on the quarter. Perhaps in line with the previous question, just any color on the month-over-month trend for new patient starts for
Niktimvo? Or alternatively, the greater than 1,250 infusions year-to-date, what proportion of that is new patients? And just any color on refill rate
for Niktimvo?
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MAY 05, 2025 / 8:30PM, SNDX.OQ - Q1 2025 Syndax Pharmaceuticals Inc Earnings Call
Question: Salim Syed - Mizuho - Analyst
: Congrats on the quarter. I guess a couple from us. Just one on Revuforj and one on the Niktimvo launch.
On Revuforj, is there any color you can provide just on the relative SKU split between the 25 mg, 110 mg, and the 160 mg, just so we can understand
what your blended WAC is per patient?
And then on the Niktimvo launch, just so I'm clear, on your slide 9 here, the 1,250 infusions year-to-date, that's as of, I want to say, April when Incyte
reported versus March 31? I just want to be clear. And that's actually infusions and not unique patients, correct?
Question: Salim Syed - Mizuho - Analyst
: Okay. Got it. And just a quick follow-up. If you use two vials, that's still one infusion, correct?
Question: George Farmer - Scotiabank - Analyst
: Given the strength of your Q1 Revuforj results, do you think that the total addressable market is accurately reflected in our models? Are you getting
the sense of how many patients might be out there? Maybe it's greater than what we've estimated. And also, can you comment, is post-transplant
use reimbursed under the current J-code?
Question: George Farmer - Scotiabank - Analyst
: Okay. Great. And maybe you mentioned this regarding the sNDA for mutant NPM1. Is that going to be based on the 77 patients in the efficacy
analysis? Or is there a larger data set?
Question: Jason Zemansky - BofA Global Research - Analyst
: Congratulations on the quarter and really appreciate you fitting us in with our question. In terms of the NCCN Guidelines, it looks like the AML
panel meets May 19. Do you think you could realistically get in front of them with your publication by then? Alternatively, if not, is there potential
for the committee to meet ad hoc?
Question: Jason Zemansky - BofA Global Research - Analyst
: Perfect. So it's fair to say probably near term rather than longer term?
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MAY 05, 2025 / 8:30PM, SNDX.OQ - Q1 2025 Syndax Pharmaceuticals Inc Earnings Call
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