Scholar Rock at Jefferies: Leadership Changes and Drug Launch Plans

On Wednesday, 04 June 2025, Scholar Rock (NASDAQ:SRRK) presented at the Jefferies Global Healthcare Conference 2025, offering insights into its strategic direction. The company highlighted leadership changes and the anticipated launch of its SMA drug, epitogromab. While optimistic about its potential, Scholar Rock acknowledged challenges in the competitive SMA market.

Key Takeaways

• Scholar Rock is poised for the potential FDA approval of epitogromab, with a PDUFA date set for September 22nd.
• The new leadership team, led by CEO David Hallal, brings extensive experience in building successful rare disease companies.
• The company is preparing for a steady uptake of epitogromab, considering existing SMA therapies and reimbursement challenges.
• A European launch is targeted for mid-2026, following a recent filing.

Operational Updates

• Epitogromab BLA Review: The review is on track, with positive interactions with the FDA and no indication of an AdCom.
• Label Expectations: Scholar Rock aims for a broad label for epitogromab, covering a wide age range and various SMA patient conditions.
• Launch Strategy: The company anticipates a gradual market adoption due to the competitive landscape and reimbursement complexities.

Future Outlook

• Epitogromab Focus: Securing FDA approval and preparing for a successful launch remain top priorities.
• EMBRAICE Study: Data from this study will be shared later this month, potentially impacting future strategies.
• Obesity Program: Scholar Rock is cautiously evaluating its obesity program, considering clinical and regulatory pathways.

Q&A Highlights

• Leadership Team: The new team’s experience in rare disease companies is expected to benefit Scholar Rock’s strategic objectives.
• Obesity Data: Regeneron’s findings on lean mass loss in obesity treatments were noted, influencing Scholar Rock’s program assessment.
• Reimbursement Landscape: The favorable reimbursement environment for SMA drugs was discussed, though challenges remain.

For further details, readers are invited to refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Michael Yee, Senior Biotechnology Analyst, Jefferies: Fantastic. All right. Well, thank you. Good afternoon everyone. Welcome to the next session here at the Jefferies Healthcare Conference.

I’m Michael Yee, a senior biotechnology analyst, and really happy to have a couple members of the ScholarRock management team with us. And importantly, this somewhat of a new team that got introduced over the last month. So I’d love perhaps, although David, you were chairman, an opportunity for you also for the webcast to just briefly introduce yourself and also Akshay, and then we’ll go into some hard hitting questions.

David Hallal, CEO, ScholarRock: Great. Thanks, Mike. We’re thrilled to be here. And given the announcement on April 28, Akshay, myself, Keith, and Vikas are really excited about the next phase of growth for ScholarRock. A little bit about my background.

I’ve spent about thirty five years in the space at companies like Amgen, Alexion, Biogen. As it relates to ScholarRock, as Mike noted, while I’m rounding out my first month as CEO, I’m starting my ninth year as board chairman. And so I have a lot of personal investment in where we are today as an organization, and more importantly, where we’re going from this point forward. And I’ve been working on Scholar Rock for quite some time with my partner, our President of R and D, Akshay Vaishna. Akshay?

Akshay Vaishna, President of R and D, ScholarRock: Thanks David. Delighted to see everybody. Good morning, good afternoon, good evening wherever you are online. And great to join you and the other attendees at this meeting. I’ve, as you know, been in biotech since ’98.

We met first at Biogen in 02/2002. We had fun working together there. And then we kind of reunited back at Scholar Rock, which was which was great. And I’ve had my journey since then through Alnylam for nineteen years after that stint at Biogen. And thanks for dragging me out of retirement to have some fun at Scholar Rock.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Yes. Well, I mean, maybe that’s a good sort of opening question because it is a important question since that announcement last month, which is, you know, for for David, what would what what or why would you move from chairman to CEO and wanna do this, from an operating chief executive officer role when you were chairman and overseeing it anyways? And for Akshay, coming out of retirement, obviously super successful R and D career at Alnylam. Why would you come over to do this when you were in retirement? For both of you, what spurred that?

It was a big announcement a month ago, to be fair.

David Hallal, CEO, ScholarRock: Yeah. Thank you. And I think it caught you by surprise, Mike,

Michael Yee, Senior Biotechnology Analyst, Jefferies: a little Definitely caught me

David Hallal, CEO, ScholarRock: Look, while we’re on this theme of coming out of retirement, I’ll say that I became board chairman at Scholar Rocket. It was the first thing I did after eleven years at Alexion, building that into what we think became one of the special global rare disease powerhouse biotech companies. And I saw a lot of similarities at Scholarock as to what I saw at Alexion. Remember this Mike, complement wasn’t new, but Alexion could drug complement unlike any other company in the past that had failed trying to drug complement. And what I saw at Scholar Rock in 2017 was the opportunity to drug myostatin and do things differently than any other company had done in the past.

And as we all know, there had been many failures in targeting myostatin. And so over the course of this eight year journey, we’ve had some ups and our share of downs. And any successful biotech company is going to have any number of near death experiences. One of those, I think, really came after the twelve month Topaz data. Six month Topaz data comes out.

I am with my dear friend Akshay, who’s on the board with me. And we said to ourselves, this is going to be a major new therapy for patients with SMA. Stock runs from somewhere in the teens up to $30 40 dollars 50 dollars a share. Twelve month data comes out to us also convincing. And yet there was sort of a read through on twelve month data that became, is it epitogromab, is it SPINRAZA, there’s no control group.

Stock goes into a slide where for several years, in essence Mike, we became the Rodney Dangerfield of biotech.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Oh my god, stock went to like $4.05

David Hallal, CEO, ScholarRock: dollars Exactly. And so why come out of retirement? Well, the theme of talking people out of retirement dates all the way back to Jay Backstrom, who’s one of the best hires I ever made. He was the Executive Vice President of Acceleron when they were acquired by Merck for $11,500,000,000 At Acceleron, they were largely drugging the same targets that we were at Scholar Rock And I thought he was the ideal CEO at the time in 2022 to demonstrate and take us from the topaz error of a lot of doubt, but a lot of promise into the sapphire ever of demonstrating the confirmatory results that we saw in October. But when I talked Jay out of retirement, it was clear

Michael Yee, Senior Biotechnology Analyst, Jefferies: But he was out of retirement, too.

David Hallal, CEO, ScholarRock: Exactly.

Michael Yee, Senior Biotechnology Analyst, Jefferies: I’m noticing a

David Hallal, CEO, ScholarRock: theme. Right. So it was clear to Jay and I that if he comes in for a couple of years and gets us to this stage, he just celebrated a very special birthday, we were only going to have Jay for so much time. And as a result of that, we knew with the powerful data that we were sitting on, this was the ideal time for a transition to scale the company into a global biotech powerhouse. But I wasn’t going to do it alone.

Jay and I discussed what we would need in the organization along with the board. Akshay was on the board. And we thought about it, Akshay, we thought about how special could it be to take four like minded individuals that have built companies like Alexion, Argenx, and Alnylam, put us together on day one and help us scale as an organization. And do some really special things from an innovation and platform perspective in developing new therapeutics, as well as bringing up ipitogram to patients with SMA to every region around the world, which Keith

Michael Yee, Senior Biotechnology Analyst, Jefferies: just recently add to that, because while two of you are up here, two others actually I think are important to drive a potential to have this drug around the world commercially, not an easy task for a small biotech. And so you have two others you might want to call out their names in terms of what they came from and why you think that their experience should be able to help launch this drug successfully around the world.

David Hallal, CEO, ScholarRock: So Keith Woods and I first came to know one another at Amgen, then worked again together at Alexion, and then his best work to date has been what he did as chief operating officer at Argenx and and and really driving home a very successful launch of Vivgart, not only in The US, but in 30 countries around the world. He joins us as Scholar Rock’s chief operating officer. Once again, just like Akshay, talk Keith out of retirement. It was not just me. It was the opportunity at Scholar Rock and the opportunity of the four of us to work together.

And then, Mike, I’m now commencing my third consecutive decade of working with Vikas Sinha, who for twelve years oversaw the build out and scale at Alexion globally where he was the CFO there and really helped us to build an extremely efficient company on both the top line and the bottom line and build our strategy that that really was built to last. And we think the combination when we all sat together for dinner, it wasn’t just any one of us. It was the combination of four of us coming together with our collective experiences, but our desire to do good for patients, which really make at this moment in time what we’re doing to prepare for the launch of epitogromab really special.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Perfect. Okay. So the four of you definitely have a long tenured track record of having done it very at some of the most successful orphan rare disease companies. And hopefully that is setting the stage for what you should do for Scholar Rock here on the precipitous of an FDA approval for another rare disease drug. Okay, so let’s take some of that because there’s certainly no shortage of important developments coming.

All of this sort of happened like a month or two before some important phase two obesity data in myostatin. So actually what, just days ago another company, Regeneron, put up some obesity myostatin data. And Lilly’s got their data in a couple weeks. Tell me about your phase two myostatin obesity readout. What should we expect given that it feels like Regeneron has put a bar out there of fifty percent?

Do you think that’s a reasonable bar? Are you gonna be better? Lower? You know, what what should we expect?

David Hallal, CEO, ScholarRock: Thanks, Mike. I’ll make a few comments.

Michael Yee, Senior Biotechnology Analyst, Jefferies: And when’s his data coming? I guess June. June.

David Hallal, CEO, ScholarRock: So we are in the month in which we will provide you all detail once we see it on our EMBRAICE study, our exploratory phase two study, which compared patients newly starting on tirzepatide with or without epitigramab. And the readout is a twenty four week endpoint looking at preservation of lean mass. And so we’re excited to have a look at that data and share it all with you later this month. We do think that Regeneron in many ways sort of underscored a lot of our thinking at Scholar Rock. As the world leaders in myostatin biology, we felt like it was our obligation to understand how we might be able to address one of the blemishes with GLP ones, and that being the loss of muscle.

And so that’s why we embarked on our journey. A couple of things from the COURAGE trial and then I’ll bring Akshay in. I think it confirmed what everybody knows is about a third of overall weight loss comes from lean mass, not an ideal outcome from GLP-1s. Number two, I think it demonstrated that myostatin alone can provide important preservation of lean mass. I think it also underscored as we said, safety is at a premium in this patient population and should one inhibit more than myostatin there could be some unintended consequences that would really limit a product profile in this setting.

And I think we saw some of that for sure with the triplet regimen. And then one other thing I would just note is that we’ve continued to see an exquisite sort of safety profile with our therapy of ipitigramab with the unique approach at Scoloroc. And we again, we look forward to having a look at our data for the first time and sharing it with all of you. And Akshay has been thinking a lot about what we saw earlier this week from Regeneron and what to expect with Embrace. And I would just hand it over to him to comment.

Akshay Vaishna, President of R and D, ScholarRock: Yes. You covered a lot of it well, David. I mean, I think the COURAGE data from Regeneron validate all the work that had gone on in mice, from ourselves, from others, investigating anti mystatin in combination with GLP-one in diet induced obesity and other models. And clearly, the Regeneron data encouraging in terms of the preservation of lean mass, which I think is highly desirable. If we think about this being maybe the first chapter of the obesity story, there are many chapters to go.

If patients are going to be on these therapies for a long time, which they probably will be or are cycling on and off, to lose 33% each time of the mass as muscle is just not the right thing to do. It’s not right metabolically. It’s not right from a functional perspective. And David, said aesthetically as well. I mean, it can change your appearance and not always for the better, depending on muscle atrophy.

So I think the Regeneron data do signal that this class of treatment will be continued to be studied in the future. However, the other thing for us from a Scholar Rock perspective is that as with many other anti myasthenia antibodies, there was that safety signal that many people have noted, particularly in the high dose arm with the anti myasthenia antibody. And I think the treatment emergent severe AEs were roughly fifty percent greater and the serious adverse events were about twice the rate. That’s notable, I think. And I think we all want to understand those issues better.

Myostatin has been a very difficult target to drug. I think our safety experience with it and the way we’ve approached the way the antibody was built in the first place stands us in good stead. And we’re very encouraged about the safety profile we have. And so we look forward to the IMbraCE data. It’s only a very short period away now.

And I think the preservation of lean mass is something we look forward to. Hard to speculate on the quantity. Also pretty confident that from a safety perspective we’ll continue to look good.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. So they kind of set a level and a number that I think honestly a lot of people thought is not shocking either way at 50%. Previously, the management team had said 20 to 40% is kind of good. Is that a well, at least powered for that, I guess. Right.

And so how do you kind of thread 20 to 40% versus 50%? You know, how are you thinking about that? Appreciating safety is important.

David Hallal, CEO, ScholarRock: Yeah. I’ll start. I mean, we’re within, you know, the month in which we’ll disclose it. So I guess we’ll know it when we see it. Again, I think for the first time, like you all, we saw the Regeneron data, and that kind of sets a bar on what one can expect with the inhibition of myostatin alone.

One of the things Mike that we’re still asking ourselves is, okay, six months can only tell you so much. It seems to make sense that preserving lean mass over a longer period of time may garner more insights clinically from a metabolic functioning and even aesthetic perspective. So I don’t know whether it’s 20%, forty %, fifty %, or something different in there, what it all means yet. I think everybody’s still trying to understand what’s the clinical regulatory approach in an evolving marketplace for the GLPs in and of themselves? And I know that Akshay and I, along with Keith, and because we think about how important it is for us to stick to our knitting in rare severe debilitating neuromuscular disorders with an opportunity to serve patients globally with SMA.

And then under the leadership of one of the best R and D executives in the industry thinking about the pipeline and a product as we think about additional rare severe and debilitating neuromuscular disorders. And do we want to just be careful not to necessarily step into a trap by following something that still has plenty of questions associated with it, but nonetheless some important data that does indicate that there can be a role for myostatin inhibition in this patient population.

Michael Yee, Senior Biotechnology Analyst, Jefferies: I think I heard that loud and clear, but it’s certainly also the analyst view. And I would say Wall Street view that the primary focus, which is a perfect transition into the SMA opportunity and then other indications like DMD, that should be your bread and butter and where you are spending tremendous amounts of time and focus. Whereas obesity is interesting, well you said trap, but you know, the idea is that we need to figure that out bit and see where the landscape goes and that’s, you know, per and it’s always been said it’s something that’s possibly partnerable. And so let’s see how that goes. So let’s transition then into the idea that you are on file for epitomegrab and have a PDUFA date around September 22.

David Hallal, CEO, ScholarRock: Right.

Michael Yee, Senior Biotechnology Analyst, Jefferies: I think I forgot that right. And therefore, how have FDA interactions been in the CEDAR group of the neuro division, or which division?

Akshay Vaishna, President of R and D, ScholarRock: That’s right.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay, you filed, how are the interactions, how are things going? We’re into June, The PDUFA date’s only four months away. Marty Makary will be here in about ten minutes. Maybe we’ll bring him in the room. But no, in all seriousness, tell us about your ongoing interactions with FDA and what you feel about with how things are going.

David Hallal, CEO, ScholarRock: Akshay?

Akshay Vaishna, President of R and D, ScholarRock: Yeah. I mean, thanks, Mike. It’s obviously been a few months now, so we’re well underway. This is neither the right time or place to go into the details of the day by day with the FDA. But one thing I can reassure everybody is that notwithstanding the noise we’ve heard about what’s going on in D.

C, from our perspective, the BLA review has gone well. We’re happy with the progress. Everything seems to be functioning as on time. And that’s why we’ve continued to guide about September 22 as the PDUFA date. So I we really don’t have anything to report there other than good steady progress per the clock.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Well, would that there there’s no sign or nor messaging of any AdCom. Is that safe to say?

Akshay Vaishna, President of R and D, ScholarRock: So, you know, I mean, I think everyone would agree that if there was gonna be an AdCom and we’d heard that, we’re obliged to share it. And just the very fact that I haven’t said that today should signal that today we haven’t heard about the need for an outcome.

Michael Yee, Senior Biotechnology Analyst, Jefferies: And then also the obesity data that’s coming with the drug that is standard practice to have to submit that data and just send that in because the patients have been treated on that. Even though I hope that wouldn’t trigger a major amendment, but that’s just additional safety.

Akshay Vaishna, President of R and D, ScholarRock: Yeah, no. We’ll do a day 120 safety update as per expectation. That’s all just SOP. You just do that. We have no surprises.

So it’s all good.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Okay. And so therefore, things are progressing on track. And how are you thinking about a label? Philosophically, obviously, like the fact that you ran it in non ambulatory, but then obviously ambulatory is a key part of the market. Obviously age groups, your primary analysis was based on two to 12, but you know SMA certainly spans beyond that.

And you ran this study because you wanted to focus on a group to ensure success, right. We don’t want a huge heterogeneous population. Actually, you look at Biohaven’s design. They had a whole bunch of things going on. And then Roche also is planning to do ambulatory, non ambulatory, a whole bunch of things.

So that could be risky. But it also means that they could have a broader label. So do you expect a broad label, or what is the view about that to set expectations?

David Hallal, CEO, ScholarRock: Yeah, maybe I’ll start and bring Akshay First of all, we are very proud of our development program for ipilimumab and took no shortcuts with the robust nature of the Topaz Phase II study, which was hypothesis generating and really helped us to design the SAFIRE trial, we now have more than 95% of those patients from both of those trials. More than two thirty patients remain on our long term On X study. So as you might imagine, some of those patients have now been on therapy beyond five years. We’ve most recently released the four year data from Topaz. So we think that body of evidence and the way the FDA has looked at SMA as a single disease bodes well for us in terms of our ambitions to be able to reach as many patients with SMA as possible.

And Akshay, we and I’ll hand it over to you. We often talk about how the biologic plausibility in the way that this therapy works and really bodes well for how many patients we can serve independent of ambulatory status and or age. Akshay?

Akshay Vaishna, President of R and D, ScholarRock: Yes. So I mean I think it’s fair to say most people would agree that the role of myostatin in health and disease throughout life is well established now. And we’ve certainly validated that in SMA. And as we’ve done our SMA work and David was alluding to, we see efficacy across the entire age range from two to 21 which we formally evaluated and we’ve seen that across two studies. I don’t for a minute think given that myostatin is a physiological player in muscle throughout life, that if a child is one and a half year old years old that suddenly it’s not working there, we know myostatin is there in SMA children from birth.

We know it’s there to be inhibited to help them progress better than they do on SMN correctors alone. So our anticipation would be both biologically and based on the data that we’ve seen that it should work in younger patients and it should work in older patients beyond 21. You said the primary efficacy population was two to twelve, which is correct. But of course, as the program has gone on, Topaz and Sapphire, children who are two to 12 have gotten older and many are beyond 12. And that they in Topaz, we’ve shared up to four years of data.

Many of those children are well beyond 12. They continue to have great efficacy.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Well, phase three, you had a whole cohort above 12.

Akshay Vaishna, President of R and D, ScholarRock: Right. And then they have progressed beyond 21. And so I think there’s a wealth of data.

Michael Yee, Senior Biotechnology Analyst, Jefferies: So you don’t think age is even relevant in terms of what

Akshay Vaishna, President of R and D, ScholarRock: the I mean, I’m giving you the scientific argument from our data. Now, ultimately, the agency has to be the arbiter, right? But I think the concept of a single disease and the rationale for myostatin as a target in our data make a great package for them to to adjudicate on. So that’s what we’re hoping.

Michael Yee, Senior Biotechnology Analyst, Jefferies: And then ambulatory, non ambulatory, I mean, that’s almost fifty fifty, but, you know, it’s a proportion of the of the disease. And we’re talking about the difference about whether someone needs walking assistance or a walker or whatever versus someone who doesn’t. And whether or not that would be relevant.

Akshay Vaishna, President of R and D, ScholarRock: Yeah, mean we certainly studied ambulatory patients in cohort one of the topaz. And we saw some positive data there as well. So again, this is a single disease attenuated by the SMN2 copy number. And really, biologically, it makes every sense to treat it as a single disease in which our hypothesis antagonizing mystatin is going to help create benefit for these folks.

Michael Yee, Senior Biotechnology Analyst, Jefferies: It would definitely be clear there would not be a type one part of the label. There’s a type two, three. Is that fair too?

Akshay Vaishna, President of R and D, ScholarRock: Well, we’ve already said that we’ll be studying zero to two years of age range formally. So, you know, that should say to everyone that we want to unequivocally demonstrate what we already believe based on the science will occur. So we will be doing that work.

Michael Yee, Senior Biotechnology Analyst, Jefferies: My point was type two three versus type one. Yeah. I do not I I don’t think anyone would think you would be inclusive of a type one in the label.

Akshay Vaishna, President of R and D, ScholarRock: Yeah. I you know, this Part of market. Yeah. Generally speaking, type one will present very early. Yeah.

But this whole distinction between type one, two, and three, and four, you know, is becoming less and less relevant, I think, to physicians and families. And it’s the question of what’s the degree of severity of your disease, what’s the best treatment for you?

Michael Yee, Senior Biotechnology Analyst, Jefferies: Well, thing is I believe, and this is market work, is that type one patients are obviously start and present early on in Yep. But because of the underlying correctors and drugs that people are getting now, they are living now towards ages where they are part of the market and are potential customers. Now the idea of type one versus two, three is based on copy numbers. But if they’re three, four, five, six, seven years old, just because they have a type one copy number, why would they not be able to get the drug? Now technically you didn’t study them.

Akshay Vaishna, President of R and D, ScholarRock: But

Michael Yee, Senior Biotechnology Analyst, Jefferies: I guess if you looked at it, you’d like, well the guy’s non ambulatory, he’s six years old, what’s the problem?

Akshay Vaishna, President of R and D, ScholarRock: Yeah, I mean I don’t

Michael Yee, Senior Biotechnology Analyst, Jefferies: think type one, two, three may also may not be so relevant. I don’t

Akshay Vaishna, President of R and D, ScholarRock: No, no. I I fully anticipate that, you know, for the patients that we’ve studied, we’ve a case for antagonizing mystatin in the entire population, including type ones. Okay. And now, you know, the agency will have to do their thing. But I there’s no reason why the drug should suddenly not work in a five year old who was classified as type one.

Michael Yee, Senior Biotechnology Analyst, Jefferies: All right. Last couple of questions and last couple of minutes. So one of the things is that if this drug is approved later this year, there are existing drugs out there. So in one sense it could be a strong launch because everybody knows where the patients are. They’re at these centers.

You’ve been at the centers. Do you think that this should be a strong launch? And how should we think about that because people are already on existing drugs? Those are expensive drugs. But generally the reimbursement arena has been pretty favorable for these So how are you thinking about a strong launch?

David Hallal, CEO, ScholarRock: So it’s a great question, Mike. First of all, from a reimbursement landscape perspective, you’re absolutely right. In fact, without any well designed controlled trials, there’s a reasonable proportion of patients that even have been receiving and being reimbursed for more than one SMN targeted therapy.

Michael Yee, Senior Biotechnology Analyst, Jefferies: So they get gene therapy literally a year or two or three later, they can get on SPINRAZA.

David Hallal, CEO, ScholarRock: And that is being It’s out there. The patient community, the medical community, and the payer community is supporting that. As I think about sort of the kinetics of the launch, I think certainly a tailwind is that unlike our experience at Alexion where we had to really invest in deep, deep disease awareness and diagnostic initiatives, here the patients are known. There are some headwinds though. I think the headwinds would be sort of you’re launching without a J code.

You’ve got to go through individual payer processes with a reasonable proportion of patients being state by state Medicaid. You’ve got a lot of large centers that, again, logistically want to get set up and sort of maybe stage their patients in terms of who gets therapy and when. And there might be their own internal processes to set themselves up for that. We are extremely optimistic over the long run for our opportunity to serve patients. And I think we also want to be thoughtful.

We would expect a consistent and steady addition of new patients each and every quarter. But I don’t necessarily see it as a massive bolus like we saw, you know, maybe with SPINRAZA when that ushered in the first new era of treatment in SMA back in 2017.

Michael Yee, Senior Biotechnology Analyst, Jefferies: I think the feedback, and we’ll certainly do more work as we get closer, it’s June, that there will be patients that are identified in advance, that those patients at those centers be good candidates, and those are early patients that could come onto the drug.

David Hallal, CEO, ScholarRock: So Yeah. Then one other point I’d make, Mike, that I know you know quite well as we presented at our MDA Presentation. Presentation in March in Dallas. You saw the Saphyr patients who were a little later. You saw the Topaz patients who were a little earlier.

And I think each center and each investigator will make those decisions on which patients they want to try first. Because early has provided some incredible results. Late has reversed disease progression back into motor function gain. And so we think there’s a wide range of patients that are gonna benefit from therapy.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Now given that you have a whole team now that has been has a track record of executing on these drugs around the world, you did file in Europe, correct? So that was around the same time. So that’s an approval date early part of twenty six?

David Hallal, CEO, ScholarRock: It might be closer to mid year. Yeah.

Akshay Vaishna, President of R and D, ScholarRock: That’s right.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Mid-twenty six, Okay. But that is also on tap two, so we’ll we’ll we’ll pay attention to that as we get into ’26.

David Hallal, CEO, ScholarRock: Yep. Right.

Michael Yee, Senior Biotechnology Analyst, Jefferies: Good. Well, you guys very much. Know we have a ton of meetings and then also more tonight. Yes. And thank you guys very much for being here with us.

David Hallal, CEO, ScholarRock: Thanks, Mike. Thanks, Mike. Thank you.

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