Syndax Pharmaceuticals at Jefferies Conference: Strategic Growth and Expansion

On Thursday, 05 June 2025, Syndax Pharmaceuticals (NASDAQ:SNDX) presented at the Jefferies Global Healthcare Conference 2025, marking its transition into a commercial-stage biotech firm. The company highlighted its recent achievements and future ambitions, with a focus on new drug approvals and market expansion. While the firm is optimistic about its growth prospects, it remains vigilant in navigating evolving industry policies.

Key Takeaways

• Syndax Pharmaceuticals launched two new drugs, RevuForge and Niktinvo, with strong initial sales.
• The company aims to expand its market presence, targeting over 50% market penetration for RevuForge in the first year.
• Robust intellectual property protection is secured until 2040, supporting long-term growth.
• Clinical development is ongoing, with significant milestones expected in the next twelve months.
• Syndax is confident in managing policy changes due to its U.S.-based manufacturing.

Financial Results

• RevuForge Launch:

- Achieved $20 million in Q1 sales, surpassing expectations.

- Aims to capture over 50% market share within the first year.

• Niktinvo Launch:

- Generated $13.6 million in Q1 sales, driven by strong demand.

Operational Updates

• RevuForge:

- Prescribed by 44% of Tier 1 and Tier 2 institutions by March, with expectations to exceed 50% soon.

- Payer coverage increased from 70% to over 90%.

- 80% of patients receive the drug within a week.

- Average treatment duration projected to be 4-6 months initially, extending to 9 months long-term.

• Niktinvo:

- Adopted by nearly all 150 significant U.S. transplant centers, with repeat orders common.

Future Outlook

• RevuForge:

- Anticipates NPM1 approval and guideline inclusion.

- Conducting frontline combination studies for both fit and unfit AML populations.

- Phase one studies in fit populations and phase three EVOLVE study in unfit populations are ongoing.

• Niktinvo:

- Exploring earlier lines of treatment through ongoing studies.

- MaxPyre IPF trial results expected by mid to late next year.

Q&A Highlights

• RevuForge:

- No significant resistance from physicians due to clear dosing and well-documented side effects.

- Positive data from BEAT AML study, with 100% MRD negativity and 67% complete response.

• Niktinvo:

- Welcomed by physicians for its impact on fibrosis and inflammation.

Readers interested in a deeper dive can refer to the full transcript for more comprehensive details.

Full transcript - Jefferies Global Healthcare Conference 2025:

Baozhi, Senior Biotech Analyst, Jefferies: Good afternoon, everyone. Thank you for attending Jefferies Global Healthcare Conference. My name is Baozhi, a senior biotech analyst biotech team here. And please join me and welcome CEO, Mr. Michael Metzger CMO, Mr.

Nick Batwood and COO, Mr. Steve Closter from Syndax Pharmaceuticals for this fireside chat session. Welcome.

Michael Metzger, CEO, Syndax Pharmaceuticals: Thank you, Kelly.

Baozhi, Senior Biotech Analyst, Jefferies: Maybe let’s start with a high level question. Last year 2024 was a very exciting year for Syndax with two product approvals back to back and you’re now transitioning into a commercial stage biotech company. 2025 is certainly also a pivotal year for the company as we look forward to many milestones, both clinically and also commercially. Maybe on a high level, tell us about your long term vision for the company and where you see the company heading to.

Michael Metzger, CEO, Syndax Pharmaceuticals: Yeah, first of all, thank you for having us. It’s great to be here with you and exciting time for the company as we head into 2025. Transformation year for us where we have two first and best in class medicines in markets where unmet need is very high. And so we are blazing our own trail here and building these franchises. We have the ambition and the fortitude with a great team, which we’ve built over many years.

Now we have the team to take us to the next level, expand the business beyond the relapsedrefractory markets that we’re in today, and really go to the front line and build franchises for many years. These are long IP assets, assets that will endure through and up to probably 2,040. So we have a long life ahead of us in terms of building these franchises. And we are super, just super excited to be getting going here and do everything we can to bring more and more product to patients.

Baozhi, Senior Biotech Analyst, Jefferies: Okay. You have made fantastic milestones internally. At the same time, we also look at external factors and think about outlook of any biotech company under the evolving policies on tariffs and also drug pricing. Maybe talk to us about your manufacturing supply chains and Medicare Medicaid exposures? And how we should think about impact on overall business for Syndax?

Michael Metzger, CEO, Syndax Pharmaceuticals: Yeah, I think the main takeaway is that we have very little impact on some of the things that have been discussed in the news, tariffs, what have you. I think the supply chains are robust and intact. We source ingredients and build our products in The U. S, manufactured final goods in The U. S.

So we see very little impact As I said, our products are domiciled in The U. S. In terms of IP. So that’s not an issue.

So in terms of our situation, I think we have probably some of the best we’re situated probably as well as you could be for these type of factors.

Baozhi, Senior Biotech Analyst, Jefferies: Okay. Let’s dive into RAV4’s launch, which is one of the key focus from investors. Let’s begin with the first quarter number. You achieved $20,000,000 in sales surpassing many expectations. Can you talk about what are you have been observing the second quarter moving forward?

How should we think about the launch trajectory for the whole year?

Steve Closter, COO, Syndax Pharmaceuticals: Yes. Thanks for the question, Kelly. And I appreciate the way you phrased it, exceeding expectations for the first quarter. So we’re very proud of that. We have a great team in place and a lot of planning in order to execute against the launch.

So really three things that we think about that really drive launches, not just in the near term but in the long term. One is the user base. We’ve got a broad and growing user base. Previously we’ve talked about these tier one and tier two institutions. A couple hundred of the largest treatment centers in the country.

Made a lot of progress there. Through March we had estimated about 44% of them have written. That’s gonna be well north of 50%. One other thing about launches you need to cover is just the payer space. You need the drug paid for by payers.

Our formulary coverage has evolved very rapidly. We were just above 70% in March and now we’re north of 90%. And the third thing that’s important is just getting patients on drug quickly. We’ve got great specialty pharmacy partners, a great trade team, and we’re able to get patients on drug. Eighty percent of them within a week and some within just a couple of days.

And we compare that to other targeted AML launches, we’re well above benchmark, which is great. It was a great Q1. As mentioned from a sales and a demand perspective, momentum is certainly building. We’re looking to bring in new patients. That’s really our primary goal.

As well as getting patients, obviously, on continued treatment, but also importantly, to get them to transplant. Because for KT2AR relapsedrefractory patients, urgent unmet need, the goal is to get them to transplant. We’re seeing more and more of that every day and ultimately back on maintenance treatment. And we think a good number in terms of market penetration into our primary market, we think we can get to over fifty percent our first year which would be a great year.

Baozhi, Senior Biotech Analyst, Jefferies: Great. And this first approval is in the KMT2A population. Could you maybe help us to understand the treatment duration average and in word range and also any new learnings on some of the patents with regard to how ravilforge is being used in practice? Is it also beyond the KMT2A population? And how about frontline use as well?

Steve Closter, COO, Syndax Pharmaceuticals: Happy to take that, too. I think the first part was around the length of treatment. So we’ve talked about this previously in part of our TAM based on the clinical trials. We think long term patients could be average about nine months. That’s different patients.

Those who do not get a response, those who do. And obviously those who get back on transplant and they’re back on for maintenance treatment. I think the expectation in this first year, it’s going to be somewhere in the four to six month range. And I say that because I think this is also part of your the second part of your question, which is the range of patients and the type of patients that are put on treatment. So as you can imagine, as you enter a market at a point in time, you’ve got patients that are relapsedrefractory with KMT2A rearrangements that really span the spectrum.

You’ve got patients that are newly relapsedrefractory. On one end we’ll call them first relapse patients. And on the other end you’ve got patients that are very, very sick. They’re very deep into their treatment journey, heavily pretreated, later lines of treatment and some are brought off of hospice. So the range of success, let’s say, that broad patient population is going to be a little variable.

What we’re going to see, and we’re already seeing this over time, physicians are telling this, we can pick this up in the data, that patients are moving earlier. First relapse, which is where the indication is, that’s where the intent to use it. And those patients will have better treatment success. Again, likely getting a response, going to transplant, and the assumption because physicians tell us this, the intent is to put them back on treatment. That’s almost universal amongst all hematologists and transplanters.

So, that’s where we’re at.

Baozhi, Senior Biotech Analyst, Jefferies: How is the real world experience of using Reviforge is different from clinical trial experience?

Steve Closter, COO, Syndax Pharmaceuticals: I think some of that is in the question I just answered in a sense. Now the trial had patients that were heavily pretreated, much later line patients. And the results in the trials were quite good, right? About a quarter of patients ended up going to transplant. I think what we may see, and it’s early to tell, but I think these are things that we’re hearing from physicians.

We were just at ASCO, which I know some of you folks may have been at. We had an advisory board. Ten of the leading hematologists in the country are telling us the success that they’re having with the drug. So as it relates to that versus clinical trials, I wouldn’t be surprised if, frankly, we see better results in the real world compared to the dataset that form the basis for registration.

Baozhi, Senior Biotech Analyst, Jefferies: Given this is the first ever approved drug for this very hard to treat population, I think it’s safe to assume physicians and the patients are very enthusiastic. But if your sales team ever receive any pushback, what could be the reasons?

Steve Closter, COO, Syndax Pharmaceuticals: Yeah, great point. Mean, think urgent unmet need. Revuforge is quickly becoming the standard of care for this population. And you think long and hard, what can you expect in the marketplace? We’ve got a great label.

We knew that as the label got approved. And more importantly, what we’re seeing real world is side effects that are consistent with the label. Physicians can certainly manage it. There’s nothing keeping them from getting patients on drug. The dosing is incredibly clear.

Side effects are well documented. The treatment teams at any institution, it’s not just the hematologist, there’s nursing support care, there’s PATH lab, there’s other folks. We’ve got a customer facing team, nursing staff. We’ve got an ample medical affairs team that can answer any questions. So, early experience has been, I would say, excellent.

There’s nothing keeping patients from getting on drug, whether it’s something within the profile, something that payers are throwing at them. So, no obstacles. It’s really finding patients and educating physicians. And we’ve been able to do both pretty successfully so far.

Baozhi, Senior Biotech Analyst, Jefferies: Great. And also, on safety front, how physicians are managing, for example, QTCE prolongation and also on differentiation syndrome, it cannot be avoided given as part of the actual mechanism of action and how physicians actually give you feedback.

Steve Closter, COO, Syndax Pharmaceuticals: Yep, good question. And it’s eyes wide open. You you don’t know what you’re going to see once a drug is put into the real world. But as mentioned, we’re seeing what’s in the label. So you train to that.

Hematologists and their staff are expert at caring for these patients. They’re complex. Treatment is often intensive. So things like DS, eyes open wide. You need to know that it could come and if it comes, how to manage it.

So physicians are able to do that with RevuForge. Same thing with QT. It’s not uncommon whether or not you’ve got a drug that may cause QT. You’re going to do an ECG, You may do some monitoring ongoing. And with QT, you monitor it, you manage it, you move on.

It has not been a hindrance at all to get patients on treatment or to keep them on. So, so far, tons of success. And that experience base is building each and every day. And I think for some physicians you often ask, how long does it take to get comfortable with a product? And it’s really two to three patient experiences.

And across our user base, that’s probably the average number of patients treated and that’ll only increase over time.

Baozhi, Senior Biotech Analyst, Jefferies: Great. And also, what percentage of the KMT2A patients also bear other gene mutations such as FLT3? And how do physicians prioritize treatments with many inhibitors and also other targeted therapies?

Nick Batwood, CMO, Syndax Pharmaceuticals: Nick? Thank you, Kelly, and thank you for having us. So co mutations are relatively rare in KMT2A. They’re actually more common in MPM one subtype of AML. We’ve actually looked at that and explored it.

FLT3 essentially comes in two variants. There’s an internal tandem domain variant and a tyrosine kinase domain variant. The ITD variant is a little bit more common. It actually has a slightly worse prognosis. Importantly, we’ve actually looked at that subset of patients in our AUGMENT study and actually found really quite good activity in terms of CR or CRH.

So in that subset of NPM1 patients responded really quite well to Revuforge in our pivotal trial.

Baozhi, Senior Biotech Analyst, Jefferies: Great. And you recently submitted supplementary NDA for NPM1 patient population. Tell us how should we think about review process and timeline?

Michael Metzger, CEO, Syndax Pharmaceuticals: Right. So we did submit the sNDA in April. And this is our, of course, under priority review would give us a six month clock to approval. Now that clock starts at the time of submission, so there’s no acceptance period. So you count from April, which puts us in the October time frame assuming that we have accelerated approval I’m sorry, priority review.

That’s different than an NDA where you have six months from the time of acceptance, which is two months into your once after your submission is complete. So we’re first to market for both indications. We expect to be approved ahead of any competition on NPM1. Sets us up for success. And importantly, we’ll have guidelines which hopefully the update to the guidelines for MPM1 as well, which we expect before approval.

Very important for the overall trajectory of the drug.

Baozhi, Senior Biotech Analyst, Jefferies: Are you able to narrow down the timeline for NCCN inclusion?

Michael Metzger, CEO, Syndax Pharmaceuticals: Yeah, it’s a good question. We did submit. The first step, of course, is to get the data. Then you have to publish the data. We published the data in blood, which was fantastic.

And then, of course, we had the submission right away. Once it was published, we got it into the guideline committee. It is on a certain timeline. They can update the guidelines coming out of their meetings at any time. We do expect or have the expectation that it will be included before approval.

That could be as early as this quarter, as I said. But again, there’s opportunity beyond their meetings if they want to do an ad hoc meeting as well. So we think there’s plenty of opportunity to get it in before approval. And that’s I think really important to our overall strategy to get the utilization to where we expect it

Nick Batwood, CMO, Syndax Pharmaceuticals: to be.

Baozhi, Senior Biotech Analyst, Jefferies: I think we have heard anecdotal use from physicians actually in NPM1 patient population after approval. And so how should I think about this dynamic change quarter over quarter for the rest of the year for NPM1?

Michael Metzger, CEO, Syndax Pharmaceuticals: Yeah, look, I think NPM1 is a small percentage of our business today. The way we’d like to describe it is about 90% of what we’re seeing in scripts is on label use, so KMT2A. The other 10% includes probably some MPM1 use and some combination use, maybe not only MPM1. So it’s a small percentage of our business today. We see the guidelines being a, you know, leg up to that utilization, so it will be important because physicians practice the guidelines.

It’s also important for reimbursement. Our medical field medical team has the ability to use the publication, use the guidelines as an educational tool for physicians. So that’s very helpful. So we do think utilization will go up when that when the guidelines come through. And then likewise, we see a we expect another leg up of utilization once we have the full approval.

And the reason for that is because you can deploy all your commercial resources against the label, including field medical and your reps. So I think that allows us to give us the full promotional power of what we can bring to bear. That will give us the optimal positioning towards, we think, the end of the year.

Baozhi, Senior Biotech Analyst, Jefferies: Great. And as there is high unmet need, so there is more than one company developing many inhibitors and at ASCO in the last week, there’s some data update for the NPM1 patient population. And I don’t know if your team were there and what kind of feedback have you heard from physicians and how to position RevForge relative to other inhibitors for NPM1 opportunity?

Michael Metzger, CEO, Syndax Pharmaceuticals: Yeah, well, we were certainly there. We had a great ASCO. Now I’ll let Nick maybe describe some of data.

Nick Batwood, CMO, Syndax Pharmaceuticals: Yeah, saw the data. I was at ASCO. I mean I would make the point firstly that we’re the only improvement in inhibitor currently. So we have a broad indication obviously covering the KMT2A population in both AML and ALL and that does also include a pediatric indication which I think is very important. So when you look at data for other menin inhibitors, I think our profile remains really quite compelling.

I think it’s a best in class profile, particularly I think when you look at the efficacy endpoints. And efficacy is incredibly important for these patients. They have a very short life expectancy and the physicians and the patients, they really want to get into some sort of response and give them the best possible chance of a durable remission and potentially get to stem cell transplant. So we will be updating our CR CRH data from our NPM1 AUGMENT data set at the EHA Congress and we’ll be reporting out a twenty six percent CRCRH result, hasn’t numerically been surpassed yet. Perhaps even more important than that primary endpoint is the overall response rate.

So the number of patients that actually have some sort of response. And our data is really quite compelling at forty eight percent. And that’s really important for patients. So nearly half of the patients have some sort of response. And we’ve actually just recently looked at how those patients do.

So we know we’ve reported a duration of response of four point seven months, which again I think is a meaningful duration of response in this population. But perhaps even more so than that, we’ve actually looked at the overall survival in those patients that response. So you get half of the patients into response and the median overall survival for those patients is nearly two years. So we’ve recorded twenty three months and we’ll be presenting that data in a Congress in the near future. And I think that’s really important for patients and that’s what we’re hearing from the physicians.

They’re using the drug now. They like the profile and they very much like what they see.

Baozhi, Senior Biotech Analyst, Jefferies: Okay, great. Thank you. Super insightful. Maybe actually dig a little bit deeper on the MOA of many inhibitors. Curious, how should we think about how does one many inhibitor work in two respective different population KMT2A versus NPM1.

So, in another word, if it works well in one population, can I assume it should be equally well in another one compared to competing molecule? Oh, there could be some mismatch happens for two different population. How should I think about the rationales behind?

Nick Batwood, CMO, Syndax Pharmaceuticals: Yeah, so the profiles are different from the drugs. That’s clear. I think what I would guide you towards is AML that is driven through HoxMase upregulation. And what we’ve been able to show is that actually we have the broadest profile in terms of targeting that particular pathway. So we’ve obviously now gotten approval in KMT2A.

We’ve shown compelling benefit in NPM1. We’ve also shown good activity in other subsets of AML, to your question, that is driven through the same pathway like the new 98R mutation, which is a relatively rare subset but is with poor prognosis. And we’ll be presenting some data again at the EHA meeting showing that in a cohort of those patients, sixty percent of them get some kind of response in terms of a morphological remission. In fact, one of those patients actually even went on to get a stem cell transplant and went on to maintenance therapy and was treated for ten months subsequent to that at the time of the data cutoff. So I think when you think about the different subsets of AML, up to fifty percent of AML could actually be targeted through that menin pathway.

And I think we’re very well positioned in terms of the breadth of the profile that we’ve shown.

Baozhi, Senior Biotech Analyst, Jefferies: Fantastic. Now maybe moving to frontline combo, which are the next key step for many inhibitor development. For investors not very familiar, could you actually lay out your frontline plan for clinical development where you are at for fit to unfit patient population?

Nick Batwood, CMO, Syndax Pharmaceuticals: So I think you asked just generally about frontline studies, correct? Yes. Sorry, just wanted to make sure. So maybe just to describe where we are because I think we have a leading position now moving into frontline combinations. And this is a very important part of our development of RevuForge into newly diagnosed patients in combination with standards of chemotherapy.

So we’re gonna have a broad program spearheaded, I would say, by three randomized control studies to address the key populations. So starting with the fit population, these are patients that tend to be either with a They tend to be a little fitter, often a little bit younger, and candidates for intensive chemotherapy. We have a phase one program currently to support the tolerability and identify the dose in those studies that we’re planning to report out in the latter part of this year. On the back of those data, we’ll have two randomized studies, one focused on the MPM1 population and one on the KMT2A population.

We think that those subsets of patients are different and they should be addressed in independent randomized studies and that’s what we’re going to do. And there’ll be more details on the design of those studies towards the back end of this year. In the unfit population, and this is an attractive study for us, we’re combining with Venaza. And we’ve seen very good synergies when you combine RevuForge, particularly with Venetoclax. And we’ll be presenting some data at EHA from the BEAT AML study, which is a combination looking of Revuforge with Venaza.

And what we were able to show in that study is that we identified a dose that we can token to phase three, and actually that’s the same dose as our currently approved indication, which is simple. We showed that it was really very well tolerated. There was a very low rate of discontinuations in that trial. And frankly it showed very encouraging efficacy and activity, particularly when you look at the complete response rate and the proportion of patients that went into MRD negative disease, which speaks to the depth and the durability of those responses. So in fact, the cohort we studied in that trial, one hundred percent of patients had MRD negativity and sixty seven percent had a complete response, which for those of you that are familiar with the Viali registration study for VEN will know that that’s a step change different from what was seen in that study, which gives a very good level of confidence in terms of technical success in winning in that study.

So the EVOLVE study, which is sponsored by HoVon we’re working very closely in partnership with the HoVon, is up and running. We have patients being enrolled. We have first patient first visit. It’s a large study. It’s a multi site international study.

It is actively enrolling. As we have described before, it has dual primary endpoints. And I think this is important because we’re leveraging the data we’ve seen for complete response, which we know can be used as a surrogate. It correlates very well with overall survival. So it has a complete response dual prime endpoint with the potential to serve for accelerated approval.

And we will also be following that study for overall survival to confirm that. So we’re very well placed in the frontline setting. It’s a priority for me and the team. We’re accelerating quickly into that space. More on the FIT intensive chemo studies to come later in the year.

Baozhi, Senior Biotech Analyst, Jefferies: Very informative. And maybe two follow-up question here. First, the EHA, do we expect a fresh data cut compared And also secondly, some proposed to use MRD inactivity as the surrogate endpoint for the accelerated path. And do you say, I mean, where what do you think about the strategy and also any potential risks if we think about the timing of to do imagine activity testing and also like how to think about a stats design to show significance across control arm?

Nick Batwood, CMO, Syndax Pharmaceuticals: So, to take your first question first, we’ll there will be some updated data you’ll see at the EHA Congress in terms of some Kaplan Meier’s around overall survival and other points, which I think is important to look at. So expect to see that. It’s an oral presentation at EHA. Secondly, you know, we are actively looking at endpoints that could also serve as accelerated approval. We have a number of collaborations ongoing with leading academic consortia supporting this effort and diagnostic work looking at minimal residual disease both in plasma, but also importantly in bone marrow.

We think it’s very possible that if you can more patients into MRD negative status, particularly using sensitive bone marrow tests, this is going to correlate very well with event free survival and overall survival in the FIT population. And we think exactly as we have built into the HOVON study that this could serve as an endpoint for an accelerated approval. So more details on the design of those studies to come, but I think we’re well positioned with Fantastic.

Baozhi, Senior Biotech Analyst, Jefferies: I feel like I did not leave enough time for Nick Timo. You also beat expectation for the Q1 sales and marked $13,600,000 sales. Maybe walk us through the launch dynamic you’re seeing and how do you think about the potential moving to earlier lines?

Steve Closter, COO, Syndax Pharmaceuticals: Yes. No, thanks, Claire. We have some time to get to Niktinvo. And it was good quarter, stub quarter, a little bit of inventory component, but mostly demand. I think this is a market that is overlooked and probably unrecognized from an unmet need standpoint.

Patients with chronic GVHD need more options. It’s a highly symptomatic disease. The impact on quality of life is very high. And patients can live with the condition for a very long time. So I’d say the early take on the product that we hear from physicians, a welcome addition.

It’s got impact on fibrosis and inflammation which are hallmarks of the disease. The drug, as we know, was approved in August. So there was some period of time there was an EAP program. So physicians had some experience even before its commercial availability, which happened in the late January time frame. So great response, meaning they really like what they see in the profile.

Transplant audience is pretty small. There’s just maybe 150 transplant centers of any significance in the country. And at this point, nearly all have ordered and most have ordered more than once. So good start, more to come. I think it’ll be a surprise.

It’s being primarily used in the third line or later. That’s where you expect it to be at launch. But it’ll move earlier. There are studies, as mentioned as part of the question, a study with steroids and a study with Jakafi. Studies are ongoing.

They’ll report out in the near future. But that’ll move it earlier and really open it up. There’s about 6,500 patients at any given time in the third line or later. The whole prevalent population is about 17,000. So there’s a lot of upside earlier in treatment, but drug is really off to an outstanding start.

Baozhi, Senior Biotech Analyst, Jefferies: Fantastic. And can you also help us to understand the IPF trial and when do we expect top line data and how should we think about the competitiveness?

Nick Batwood, CMO, Syndax Pharmaceuticals: Yeah, thank you. I’m excited about this trial actually. There’s two reasons I’m excited about it. One is I think there’s a compelling biological rationale in interstitial pulmonary fibrosis, why CSF1R might be effective. You know, it targets macrophages and pro myelocytic macrophages in two ways.

One is both in terms of combating inflammation but also fibrosis. And this is, you know, very relevant in interstitial pulmonary fibrosis. I think there’s two reasons why you could see that effect biologically. And we have already, if you like, proof of concept of that hypothesis from our GAVE two zero one study in chronic graft versus host disease. That, as you know, is multisystem disorder and one of the effects of that is obviously in the lung and there is a syndrome called bronchiolitis obliterans syndrome or BOS and we treated some patients with that in that pivotal registrational study.

And we saw really quite compelling both response rates and improvements in symptoms for those patients, you know, in the order of half the patients. So our MaxPyre study is a randomized study actually looking at Nictimvo against standard of care with an FVC primary endpoint, which is, you know, gonna be a measure of lung function and fibrosis. And that would be the endpoint that if we saw a successful proof of concept, we would take into a phase three program. And, we hope to see those data towards the middle, latter part of next year.

Baozhi, Senior Biotech Analyst, Jefferies: Fantastic. Michael, do you want to add something on that? No, no, no. Maybe lastly, what do investors should look for in terms of milestones from Syndax for the next twelve months? Quickly reiterate.

Michael Metzger, CEO, Syndax Pharmaceuticals: Yeah, sure. No, look, think it’s a, as I said earlier, transformational time for the company where we have data coming. And Nick mentioned some of it at EHA with our NPM1 data being presented, as well as our combination trial with the BD AML trial. So these are important data sets both in relapsedrefractory patients but also in newly diagnosed patients. We have an sNDA that’s on file.

We expect approval before the end of this year, hopefully get into the guidelines. We expect to get into the guidelines as well. So we feel we’re set up for success to launch an NPM1, which is our second indication. We have obviously important performance ahead of us in KMT2A, where we’re just ramping and seeing great uptake. We expect that to continue and build over time as that franchise really, Steve mentioned, get to 50% penetration.

So we have a lot in front of us with these two franchises, Nick Timbo as well, same story, great launch, off to a really tough a strong start, excuse me, and doing really, really well. We expect that to build over time. So I think the opportunity in front of us is to expand into frontline over time, build the data sets, build up utilization to best in class, first and best in class molecules. These franchises really can go pretty far. And we’re really excited with the team we’ve built to execute and put our head down and do everything we can to build value for this company.

So it’s a really important year for us.

Baozhi, Senior Biotech Analyst, Jefferies: Allowed to anticipate a very exciting time. We’re going to ramp up here. And thanks again for Syndax team for this great discussion. Thanks everyone for attending.

Michael Metzger, CEO, Syndax Pharmaceuticals: Thank you, Kevin.

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