Syndax Pharmaceuticals Inc To Discuss The FDA Approval Of Revuforj Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Anupam Rama - JPMorgan - Analyst : Hey, guys. tThanks so much for taking the question and congratulations on the approval. I'm just wondering, what are the gating factors to getting those 25-milligram tablets for the lower-weight younger patients? And assuming that -- and should we assume parity pricing there? And then second question is on the label negotiations, did FDA consider differentiation syndrome as a revumenib-specific AE? Or was it considered more of a class consideration for menin inhibitors? Thanks so much.

Question: Anupam Rama - JPMorgan - Analyst : Parity pricing for that tablet.

Question: Anupam Rama - JPMorgan - Analyst : Thank you, guys, for taking our questions and congratulations on the approval.

Question: Bradley Canino - Stifel Nicolaus & Co Inc - Analyst : Good evening and congrats on the second in one year. Looking at the label language, which seems to describe at least the proportion of patients that move to transplant, how do you see the ability to speak to physicians about post-transplant maintenance? And second, if you apply the same FDA analysis criteria to the NPM1 population from Phase 1, what number meet the criteria and could be included in an sNDA review? And how many of those had a CR/CRh? I think everyone will be thinking about is the NPM1 data and if they will stay consistent and above the approval benchmark. Thank you. Congrats, again. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 15, 2024 / 11:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc To Discuss The FDA Approval Of Revuforj Call

Question: Bradley Canino - Stifel Nicolaus & Co Inc - Analyst : Thanks, again.

Question: Peter Lawson - Barclays - Analyst : Great. Thank you so much. Thanks for the update. Thanks for the update. Congratulations on the approval. You mentioned about the supplemental NDA for NPM1. Will you also pursue the NCCN guideline updates as well?

Question: Peter Lawson - Barclays - Analyst : For the sNDA.

Question: Peter Lawson - Barclays - Analyst : Okay. Okay. And then your expectations around the duration of therapy in the real-world setting. How do you think that could change for the third line versus second-line patients?

Question: Peter Lawson - Barclays - Analyst : Great. Thank you so much. Congrats. Thank you.

Question: Kelly Shi - Jefferies LLC - Analyst : Congrats on the approval. So I have two. Firstly, is the KMT2A molecular testing conducted separately or along with other AML biomarkers? So specifically, if physicians wish to use off-label in NPM1 patients, is the patient genetic information available? And I also have a follow-up.

Question: Kelly Shi - Jefferies LLC - Analyst : So basically, the KMT2A molecular testing and NPM1, like -- conducted on like altogether, so you have the information available or like if physicians wish to use off-label in NPM1 patients, is the patient genetic information available?

Question: Kelly Shi - Jefferies LLC - Analyst : Okay. Thanks for the clarification. I also have a quick one. So 50% of the patients resumed Revuforj treatment post the transplant. Curious how long the patients actually stay on the treatment?

Question: Kelly Shi - Jefferies LLC - Analyst : KMT2A.

Question: Kelly Shi - Jefferies LLC - Analyst : Okay. Thank you. Thank you so much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 15, 2024 / 11:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc To Discuss The FDA Approval Of Revuforj Call

Question: Philip Nadeau - TD Cowen - Analyst : Good afternoon. Congratulations on the approval. Great news. So I guess, first, on the QTc labeling, it looks like the label is requiring monitoring once weekly for the first four weeks and at least monthly thereafter. Is that standard QT monitoring? How much of a burden will that be on the physicians and patients?

Question: Philip Nadeau - TD Cowen - Analyst : Great. That's helpful. Then second, a follow-up question on the data that's in the label. So it sounds like the 104 or so patients in the FDA's analysis, somewhat of a different population than the 97 patients that were in the ASH abstract. Will you ever be able to publish or present the data set that the FDA itself analyzed for the label? Is that something that you'd have access to that you could either release at ASH next month or at any point, put in a publication?

Question: Philip Nadeau - TD Cowen - Analyst : Great. Last question is for Keith. Keith, I think you said that the scripts from the two specialty distributors are going to be blocked, so we're not going to be able to monitor them through our typical services, is that right?

Question: Philip Nadeau - TD Cowen - Analyst : Great. Congratulations, again. Thanks.

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : Hey. Good evening. Congrats on the approval from us as well. Maybe just a follow-up. So regarding the NPM1 data that was just released earlier this week. So how does the FDA label that you have received now for KMT2A and perhaps the overall FDA interactions how does that perhaps impact your confidence in the NPM1 approval and label? And if you were to do a similar analysis, a similar pool analysis, including Phase 1 data, would that meaningfully change the CR/CRh rate for the NPM1 cohort?

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : Right. Makes sense. And then just a commercial question as we think about the first commercial quarters for revumenib. I think you mentioned it's obviously unlikely to see a patient bolus just given the short nature of progression or survival essentially. But as we think about the launch, are there any items that we should consider around inventory in stocking or other factors as we try to model the launch in the first few quarters?

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : Great. Well, thanks for taking the questions and congrats on the early news here this Friday. Thank you.

Question: Yigal Nochomovitz - Citi Investment Research - Analyst : Hi, guys. Congrats again on the very early approval. I had a question on slide 17. I'm just curious with respect to the range that you cite for the NPM1 population, 3,000 to 4,500. Is there a reason that you have less precision on that versus the other populations that you're describing? Thanks.

Question: Yigal Nochomovitz - Citi Investment Research - Analyst : Just the range.

Question: Yigal Nochomovitz - Citi Investment Research - Analyst : Yeah. No, that definitely helps. And it was commented with respect to my second question, which is, as you pointed out, it was 28% to 36%. I was under the impression that it's about 3x, as you say, NPM1 to KMT2. But this range suggests that a little lower than that. Is that a revised assessment? Or are you guys just being conservative? Can you just clarify that part?

Question: Yigal Nochomovitz - Citi Investment Research - Analyst : Yes, that does. Okay. Understood. Thank you very much.

Question: Kalpit Patel - B. Riley Securities - Analyst : Yeah. Hey. Good evening. Congrats on the approval today. Maybe one question, a follow-up from the earlier one for the duration of exposure. The label notes a median duration of exposure of 2.3 months. I guess, is there a considerable difference between the median versus the mean duration of response? Any color would be useful for modeling purposes as I think previously, we were looking at a nine-month number.

Question: Kalpit Patel - B. Riley Securities - Analyst : Okay. Understood. Thank you very much. And congrats again.

Question: Justin Zelin - BTIG LLC - Analyst : Congrats on the approval, guys. Great news. Maybe just a follow-up on the last question. I just want to make sure I heard it right. Anjali, you said nine months expected duration of treatment for KMT2A and six months for NPM1. Just want to make sure I heard that correctly.

Question: Justin Zelin - BTIG LLC - Analyst : Understood. And maybe a question for Steve. Just your expectation on the breakdown of patients getting treated at academic centers versus the community and just how knowledgeable the community docs are about treating differentiation syndrome or monitoring for QTc? Thanks.

Question: Justin Zelin - BTIG LLC - Analyst : Excellent. Thanks for taking my questions and congrats again.

Question: Salim Syed - Mizuho Securities - Analyst : Hey, guys. Congrats on the approval. Just a few from us on the ECG and QTc discussion here. So, I guess, number one, is it expected here that the ECGs will be covered by payers? And how much of that -- what should be the expected price for these ECGs that the payers would have to bear? And was this taken into account as you price the product out? That's the first question. And then I have a couple of follow-ups.

Question: Salim Syed - Mizuho Securities - Analyst : Okay. And is it your general expectation that the QTc language will apply to all menin inhibitors for other labels? Or is this something that you -- at this point, you believe would pertain only to your product?

Question: Salim Syed - Mizuho Securities - Analyst : Okay. Thank you. And just lastly, if KORA were not to get the QTc language in the warning section of their label, would you view this at all as a commercial disadvantage?

Question: Salim Syed - Mizuho Securities - Analyst : Okay. Got it. Thank you very much. And congrats, again. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 15, 2024 / 11:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc To Discuss The FDA Approval Of Revuforj Call