Regenxbio at Leerink Global Healthcare: Strategic Pipeline Insights

On Tuesday, 11 March 2025, Regenxbio Inc (NASDAQ: RGNX) presented at the Leerink Global Healthcare Conference 2025. The company highlighted its strategic advancements and challenges across key pipeline programs, including RGX-121 for Hunter Syndrome, RGX-202 for Duchenne Muscular Dystrophy, and RGX-314 for retinal diseases. While promising financial and operational updates were shared, the discussion also underscored the competitive landscape and the complexities of commercialization and regulatory processes.

Key Takeaways

• Regenxbio secured a $110 million upfront payment from Nippon Chikinyaku for RGX-121, extending its financial runway into 2026.
• The company is prioritizing broad label potential for RGX-202 by enrolling patients aged one year and older.
• Full enrollment of RGX-314 trials for wet AMD is expected this year, with the first diabetic retinopathy dosing planned for the second half of the year.
• A stockpile of 2,500 doses per year is planned for RGX-202, preparing for a potential 2027 launch.
• The company is leveraging AbbVie’s commercial infrastructure for RGX-314.

Financial Results

• Nippon Chikinyaku Deal for RGX-121:

- Upfront payment of $110 million

- Up to $40 million in potential regulatory and development milestones

- Over $600 million in potential commercial sales milestones, plus double-digit royalties

- Retained 100% ownership of PRVs for RGX-121 and RGX-202

- $200 million milestone linked to the first patient dosing in the diabetic retinopathy program

Operational Updates

• RGX-121 (Hunter Syndrome):

- Partnership with Nippon Chikinyaku to strengthen U.S. presence

- FDA inspection of the manufacturing facility anticipated this year

- Imminent filing of the BLA last module

• RGX-202 (DMD):

- Enrolling patients aged one year and older in pivotal studies

- Focus on safety with a unique immune suppression regimen

- Data from Phase 1/2 studies expected to mature throughout the year

- Plans to stockpile 2,500 doses annually starting next year

• RGX-314 (Wet AMD and Diabetic Retinopathy):

- Full enrollment of ATMOSPHERE and ASCENT trials anticipated this year

- Diabetic retinopathy program to dose the first patient in the second half of the year

- Use of the ClearSide device for suprachoroidal administration

Future Outlook

• RGX-121 (Hunter Syndrome):

- No expected manufacturing issues with the Nippon partnership

• RGX-202 (DMD):

- Significant market penetration anticipated

- Firm BLA timeline set for 2026

• RGX-314 (Wet AMD and Diabetic Retinopathy):

- Top-line data from trials expected next year

- Focus on frequent flyers needing regular injections

- Utilizing AbbVie’s commercialization strength

Q&A Highlights

• DMD Data Comparison:

- Emphasis on consistent data above threshold levels

- Interest in NSAA score improvements versus baseline and external controls

• DMD Patient Access:

- Increasing willingness to wait for second-generation therapies

- Reimbursement challenges acknowledged

- Advantage of being a fast follower in the market

For a deeper dive into Regenxbio’s strategic plans and financial details, readers are encouraged to refer to the full transcript below.

Full transcript - Leerink Global Healthcare Conference 2025:

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: Morning session or second day here at the twenty twenty five Global Healthcare Conference. And welcome to Miami, everyone, who arrived this morning. I’m Mani Frohar, senior analyst, Direct Medicines, here at Leerink. Very happy to have both Mitchell Chan and Curran Simpson from Regenexx Bio. How was the, how was the trip down, guys?

Mitchell Chan, Regenexx Bio: It was good. I was hoping the pilot would divert around the thunderstorms, but he went straight through, but got us here quicker. That sounds about that

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: that sounds very that sounds very much like Miami International Airport. I’ve had that experience.

Mitchell Chan, Regenexx Bio: But all good. Happy to be here. Happy to

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: be warm. Well, we’re always happy to have you guys. So before we dive in, let’s take a quick minute. You had the close the one two one deal. Mhmm.

Do you guys want to do a quick review of what that means for where you guys are balance sheet wise, OpEx, economics of that deal, just for those who aren’t super close to the Sure. The details. Sure. Matt, do

Mitchell Chan, Regenexx Bio: you want to take? Yeah.

Curran Simpson, Regenexx Bio: I could definitely start off with the 121 deals. So first and foremost, we’re very excited to have Nippon Chikinyaku as a partner, just because it’s not your typical household name to some, but I can reassure everyone, it’s actually a very good partnership because they have a strong presence here in The U. S, especially in the rare disease space. So I think when we’re evaluating a partnership, we really want someone who could hit the ground running as our MPS2 or Hunter Syndrome, RGX 121 comes online. So from that standpoint, that is great.

Deal economics, we received an upfront of $110,000,000 That would actually extend our cash runway well into the 2026 timeframe. On top of that, it comes with additional regulatory and development milestones. We said it was up to $40,000,000 In addition to that, we also could receive more than $600,000,000 from commercial sales milestones. That also includes royalties as well. And what we have said publicly is that it’s a meaningful double digits.

So all in all, this is a very good deal. And if you actually read the press release all the way to the bottom, I know some people just always focus on the top. We actually retained full ownership of our PRV for both 01/2021 as well as 01/2011. So 100% of the PRVs and we could debate how much these PRVs goes for these days. But we’re very happy to retain both of them.

So all in all, this is a deal that we’re very excited about.

Mitchell Chan, Regenexx Bio: I think it also has a strategic element to it as well that we’ll have an FDA inspection of the facility this year. We’ve obviously gotten very close imminently filing the last module of the BLA. And all of that work and all of that in terms of having commercial supply chain will play into the Duchenne program really nicely. So we’ll be prepared to move as quickly as possible on 02/2002 based on what we’re learning for 01/2021.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So let’s talk a little bit about that overlap. So I think the manufacturing nuance gets lost. When you presuming that we our model presumes, I think you do as well, that we proceed to launch with Nippon as expected, and there are no hiccups in manufacturing, etcetera. All the inspections go as expected, I think, as everyone up on this panel expects. To what extent does that derisk manufacturing and eliminate some future potential inspections, etcetera, for DMD?

And to what extent are we talking different lines, different facilities, it doesn’t quite overlap? Like, where like, how much how much deriskingsimplification of an eventual DMD filing does that actually give you on the manufacturing side?

Mitchell Chan, Regenexx Bio: I think it’s two things. It certainly derisks any findings that could be part of the 121 inspection, we’d have plenty of time to address. We’ve done an enormous amount of prep for 121 facility inspections as well, brought out outside inspectors that are either U. S. Or EMEA based.

And the facility audits really well. So I would argue it’s low risk. But having said that, I think it means a lot to prep for the two zero two piece. The nice thing as well is we run a platform process. So 121, if you looked at that process versus two zero two, you wouldn’t see a significant difference in the way the process is operated.

So sort of validation that 121 is acceptable will have a significant derisking effect on subsequent review of the two zero two process.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: Great. While we’re having this conversation, I’m going to jump a little bit to deeper in the pipeline, if that’s okay, to DMD. Obviously, there’s been a lot of excitement about competitor data. It’s been a tough capital market environment.

Mitchell Chan, Regenexx Bio: Mhmm.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: But cert but from the perspective of scientific interest in DMD, that remains as high as ever. Talk to me a little bit about how you think about commercial positioning versus approved agents, as well as those that are close to pivotal data slash close to entering a pivotal study. Like, where do you guys think how do you guys think you fall? How do you subdivide the market? And what And what metrics do you think will be important for deciding who gets how much share?

Mitchell Chan, Regenexx Bio: I think a lot of it plays into sort of the design of the study. So we’re enrolling patients in our pivotal one and older. So from the very beginning, we’re anticipating the opportunity to have a broad label for the program. And one of the things that we’re thinking about as it relates both to the commercial setting and also to accelerated approval is, I think, in order to achieve that, you need to have data that supports an improvement in the benefit to risk ratio. So to date, what do we have as evidence that we’re on the right track?

First, I think our safety profile is absolutely impeccable today, knock on wood. But we feel really positive that this unique immune suppression, immune modulation regimen that we have is really leading to great outcomes as it relates to safety for patients so far. So that’s where the base of the benefit to risk ratio is having really, really clear and positive safety signals. The second is then the functional aspects of it. And I keep thinking, if we just simply can repeat the early functional data that we’ve already got in the five patients we disclosed in November to a larger data set of 30 across a broad age group, we have a really, really positive, not just outlook for an accelerated approval, but in a commercial setting, I think, we already see it.

There’s a ton of interest from the patient community in the sense that their perception is that the product that’s on the market may have modest benefit. And that’s what we hear. Our goal is to show that we have consistent functional outcomes that relate to the high micro dystrophin levels we’re seeing.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So let’s talk about when we’re gonna see what in terms of functional outcomes in terms of pool of data as well, because there’s a lot of quite small pools of data floating around DMDI that are hard to interpret.

Mitchell Chan, Regenexx Bio: Yes. So if we think about the data, we dosed three patients in dose level one. That’s not our pivotal dose. But I think that data will be instructive because we’ll be out to two years at a point during this year. So we can show even at our lower dose hopefully, some level of durability, which I think is one of the issues that we keep hearing from the patient community.

They’re concerned about durability. So we may have some supportive data even though it’s not at our pivotal dose there. Then we dose seven patients in our Phase onetwo study at dose level two, which is our pivotal dose. That data set is going to mature all the way through this year. And we’re trying to bundle as much of that data together rather than piecemeal results over the course of the next month or so.

But I’d say, in the near term, we’ll be able to report additional functional data for the two patients we already reported on out to twelve months. And then we’ll see the other five patients as they get to nine months and then certainly out to twelve. So we don’t typically report anything at six months or so because we want to make sure the immune suppression is washed out. We’ll also report on additional microdystrophin level. We’re really interested to see and should report at MDA on additional biomarker data from the younger patients we’ve treated.

And then also, we’ll give updates on enrollment through the course of the year. Hopefully, something at earnings, just a start to that. But then probably mid year, we can be much more pointed on when we think the full enrollment of the pivotal will occur. So it’s going to be a busy year. We’re trying to package data as much as we can rather than piecemeal it, but we want people to know what our timeline is because we know that the timeline to our BLA still remains firm in 2026.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So from there, let’s pivot over, we’ll bounce around a little bit. Let’s pivot over to the late, I guess, equally late, later stage pipeline with AMD partnered with Allergan, part of AbbVie. Talk to me a little bit about what we’re getting this year, and how you think about commercial opportunity, given this is a market that’s evolved a bit, right, certainly since we I first started talking about

Mitchell Chan, Regenexx Bio: this with you guys in 2018. Yes. Yes, certainly. So I think three main events this year on the three fourteen program with AbbVie for the subretinal side of that, which is the OR based delivery, we expect to fully enroll both ATMOSPHERE, which is a large 600 plus patient study being recruited in The U. S.

And just as a reminder, that’s against Lucentis. And then we have Ascent, which when AbbVie became a partner to us three years back, they enlarged that study significantly. So it initially was 300 plus patients. Now it’s above 600 again. And also they globalized it, meaning we’re recruiting patients in Europe now.

Both of those studies will enroll this year, which will set us up for top line data next year. It’s a fifty two week endpoint plus or minus a few weeks. So we think that’s really exciting. And then early in the year, we talked about going through regulatory advice on the diabetic retinopathy program, which is administered differently. That’s an in office suprachoroidal administration.

And we’re just getting through global regulatory advice now that will enable AbbVie and we’d finish the pivotal protocol. We want one protocol that is used globally because the trial will be recruited that way. And then we’re expecting to dose a patient likely second half of the year as first patient in. And I think that’s meaningful. There’s a $200,000,000 milestone associated with that.

But I think even more meaningful is that the global regulatory advice we’ve gotten to date is against the sham control. And I think that explains the standard of care. There is not really an acceptable standard of care for diabetic retinopathy. And that just magnifies how we feel and how I think AbbVie feels about the opportunity that this is a perfect fit for gene therapy in our view.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So when we think about the universe opportunities for three fourteen, it’s a little more complicated than the typical, you know, single gene therapy, single defined gene, you know, there’s x number of patients, and there’s nothing for them. It’s a little bit of a different animal. Yes. Because you have two presentations in suprachoroidal subretinal. You got a fairly diverse set of markets, an extremely well served one, though I’m not the one getting a needle in the eye every six weeks, so it’s easy for me to say what AMD is well served, and then an extremely poorly served one in diabetic retinopathy.

How do you think about which presentation of three fourteen is best suited? And could you see, are there, is there tension in terms of pricing and value between those markets? Because obviously, unmet need in one AMD is different than unmet need in diabetic retinopathy.

Mitchell Chan, Regenexx Bio: I think that one thing for SCAMD is keep in mind that it’s at least two to three years behind subretinal. So we’ll have established a strong foothold with subretinal in the OR based setting. And all the feedback that we get, if wet AMD is an $18,000,000,000 market today, all the feedback we get is that, that may double in the next five years or so in terms of how many patients are out there with the size of the business. Even if you can convince yourself that only ten percent of patients would take a subretinal injection, That’s still a huge opportunity in the context of gene therapy. Patients that we think and that you’ve just heard Rupaul Thakur at AbbVie speak about, patients who are really heavy frequent flyers in terms of monthly injections, those are ones that we think are very likely to value a subretinal approach.

I would point to our recent study with the Fallow Eye treatment as an indicator that these are patients that have already done one eye in subretinal injection in our studies. Now they’re coming in to treat the second eye, the fellow eye. And I think that speaks volumes about the benefit they perceive. And also the fact that that may not be possible with other gene therapies, because the it’s immune privileged with SR injection. I think you’ll see over time though if SCAND comes on the market, that could be considered lifecycle improvement and you’ll see more of the business moving that way because it’s an in office procedure.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So while subretinal delivery and certainly intravitreal, which is the most simple, and sort of standard of care currently, these are procedures that retina surgeons, as part of their residency and fellowship training, do innumerable times. Mhmm. Suprachoroidal delivery is a little bit more novel, certainly, than IVT. Yeah. Talk to me about, the device component.

Talk to me about the training and how how much comfort retinal surgeons out in the community have with doing suprachoroidal delivery at the vast volumes implicit when you’re talking about wet AMD.

Mitchell Chan, Regenexx Bio: Yeah. We use the ClearSide device for the suprachoroidal administration. And certainly in our hands, in a clinical setting, we have trainers that go to site and perform the training there. But the fact is that that’s now a commercial device and the training has already been accomplished in a commercial setting with another drug. So I don’t feel like that will be a significant bar in utilization down the road.

But by the time we would be on the market with diabetic retinopathy, I think the use of that device will be pretty well understood. And I think most importantly, from our clinical setting, we use thermal imaging, for example, to judge how well the administration was done. And we see very high success rates. So we feel confident that that will be adopted well in a commercial setting.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So while we’re talking about sort of commercial dynamics, let’s zoom out. I don’t think it’s a surprise to anybody to say that market sentiment on the commercial opportunity for gene therapies is pretty poor, by which I mean capital markets, not clinicians and not painters. That’s a separate debate. When investors reach out to me, and certainly your investors reach out to you and your team, and they talk about, well, how do you get paid for a one time, or we’ll say highly durable, highly durable therapy, because you can do fellow eye, for a highly durable therapy in a market where the incentives are aligned for chronic dosing, you know, obviously, buy and bill, etcetera. How do you get paid for that?

What durability of data do you need to have in a pivotal? How do you justify price? How do you capture share and cash flow in a real way? How do you push back on those arguments?

Mitchell Chan, Regenexx Bio: I think one aspect of that is, I wouldn’t look at it as because this new therapy is available, it takes away from the rest of the business. The fact of the matter is most retina centers are overburdened. I don’t know if people have tried to schedule at a retina center lately, but it’s a challenge. So I think the PIs that are in our study, we have 100 sites that are activated. A good number of them, large enrollers in our study will say, I can’t keep up.

And the subretinal administration in an OR setting only adds to my business. It doesn’t subtract from my business. So I think that’s one of the ways we think about it. We’ve looked at the reimbursement landscape for a subretinal injection in terms of how people will be reimbursed, how the centers that perform these, victrectomies will be reimbursed. And we think it’s a win win in terms of where we are.

We’ve spent a lot of time making sure our cost of goods for a large sort of non rare gene therapy are in line. And I feel like the value proposition for something where we’re showing durability out to three point five, four years now on some patients is very much in hand. And certainly, we’re going to leverage the commercialization muscle of AbbVie along the way with this. And that is just another thing that I think has us feeling like this will be a successful launch and a really important therapy as part of the many options that are out there.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: Slide down the down the way down. Yep. It’s immunology cliff, back towards DMD. A place where that argument apparently doesn’t exist at all and no one argues that something’s not gonna get paid for. Clearly, reimbursement in that market is fairly robust and continues to be robust, almost independent of data quality.

But the debate there becomes access to patients and to what extent is there a pool of patients that are either, A, not yet treated by a one time viral therapy or, B, not eligible. So we think about the opportunity set, and this is a little bit of a follow-up to earlier question. The opportunity set is driven by those ineligible to a competitor that is approved ahead of you? Or do you think the larger opportunity set is patients who are choosing not to take the approved therapy for reasons of efficacy? Like how should we size those and what are

Mitchell Chan, Regenexx Bio: you tracking in the market to confirm your hypothesis? So we are doing studies on the prevalent market that’s out there. And we can also look at the consensus estimates as well for with a potential launch in 2027, how many patients would be out there just within the prevalent market and then how many of them are eligible for our therapy. It’s a significant number. It’s at least half of the prevalent market that should be still available to us at that point.

And that’s, I think, the drive for broad label and making sure that in our clinical study, we have enough exposures across those age categories, if you will, to enable that. But I think the second part of it, the reason we opened up one to four cohort in terms of age was that over time that will move to an incident population where off newborn screening patients will likely be treated early should durability be demonstrated. And we’ll have the data to support that as well. So we’re trying to prepare for making a significant inroad to the prevalent market, but also being ready to challenge on an intimate market basis. The decision that we see a lot of parents of boys diagnosed with Duchenne is often related to their disease progression.

And so for parents of children where they know their child is declining, there’s more of an urgency to go on to the commercial option. But for patients where they were maybe newly diagnosed or they’re continuing to see functional improvement, they’re willing to wait for these new class of microdystrophins. And those there’s plenty of them out there in terms of if we segment the market, this is a significant thirty percent to forty percent of the market are patients in that sort of category. And those are typically patients that are in the four percent to five percent range where they’ve been newly diagnosed, not through newborn screening, obviously, but traditional methods. So there’s a lot there.

And I think one of the things that is different for our programs than others, we’re going to begin stockpiling commercial material next year in house. So we have control of the manufacturing, we have control of the fill finish and we can stockpile 2,500 doses a year. So we won’t just launch in 2027. We’re capable of coming in really having in terms of supply availability to really make inroads to the market.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So let’s talk a little bit about, hello. So we talked about positioning for that market. Let’s talk about how to compare data between gene therapies for DMD. And every time a dataset comes out, I and all of my colleagues at other banks write a note with about a paragraph talk talking about how unreasonable it is to compare across trials and how it’s statistically fraught and completely unjustifiable, and then we spend 16 pages comparing across trial.

Curran Simpson, Regenexx Bio: Mhmm.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So when we think about functional metrics, how should what caveats would you apply as we compare your data in the future with what’s on label for the approved therapy in a somewhat different population of patients, to be fair, versus some of your competitors? Should we be mostly focused on baseline functional outcomes? Should we focus on age? Like, how should we think about not letting ourselves be sort of confused by the variability amongst this patient population? Because while DMD is universally tragic, it doesn’t progress at a universal speed.

Mitchell Chan, Regenexx Bio: Yes. I think you pointed out one of the main aspects, because we know people are going to make comparisons. We tried to avoid it from our standpoint, but we do definitely want to guide people correctly. I think making sure you’re thinking about age as part of those comparisons is really critical. Certainly, the younger patients, as our data set expands, we can see that the microdystrophin levels expressed in patients that are younger is typically higher.

And then as those patients are older and treated, you’re not quite able to get the same level of transfection as you might expect. Having said that, we’re really excited that in our older patients, we’re seeing roughly three times the level of microdystrophin. We’re seeing no patients that are coming in at zero, which I think is incredibly important. If you look back to the ADCOM data for Alevitus, seven or eight patients that you can see from Peter Marks’ graph, were at zero. And I think that really factors heavily into the decision making of a parent who knows I could treat my child.

It’s a one time treatment. You would be precluded from other gene therapies likely. And I might end up with no microdystrophin as a result. We haven’t seen that. Every single patient we’ve treated is above the threshold level that we have as our primary endpoint.

And I think that’s an important way to think about it is consistency above a certain threshold is maybe more important than thirty five percent versus forty five percent in a five year old. And so I would just caution. I think we’re really interested that we’re seeing benefit in the NSAA score versus baseline and certainly versus the matched external controls that we use. People had given up on NSAA, and I’m hoping that that’s evidence of a stronger drug effect on function. Time will tell as our dataset grows.

We know it’s early, and we’re just looking forward to updating people through the year on additional functional outcomes.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: That makes sense to me. I think one of the other debates is as people consider the decisions that’s being made by Duchenne parents, and this is largely, obviously, as one would expect, a parent driven decision. What are you seeing in terms of reticence to enroll in current current competitive agents or take current approved agents? Like, how much of a backlog of parents is there waiting for what’s next? Because it’s a heartbreaking decision these parents have to make.

Yeah. They have an approved therapy, many agents in development, but you they are running against the clock, unfortunately. So talk to me about how we should think about, is there a warehouse of patients, or those patients the very youngest? Are they the oldest and most severe, and therefore not eligible for some of the existing therapies? How should we think about the population of patients who you’ll be able to serve first?

Yeah. It’s the day after approval.

Mitchell Chan, Regenexx Bio: Yes. So I think that, it’s all the above. The patients that we enrolled early in our study were a bit older. And it was, as you mentioned, an outcome of they weren’t eligible for other studies necessarily. And so, they were interested in our program.

But I think as time has gone on and the data has come out on the biomarkers and now the functional data, it’s different. The willingness to wait for second generation therapy is increasing. And in many cases, we hear, at least in the clinical setting right now, it’s easier to enroll in a clinical study than it is necessarily to be treated with a commercial product due to the wait time on reimbursement, etcetera. Eventually, it comes, but it takes time. And as you said, the patients may not be there or the willingness to wait may not be there.

But down the road in a commercial setting, I think this is all going to come down to function and the perception of is this onetime treatment going to likely lead to a functional benefit for my son. And I feel like our data, again, if it reproduces in a larger data set, is going to be extremely compelling to a patient or a parent of a patient diagnosed because that’s what they care about is can they play sports that they couldn’t play before, can they ride a bike that they couldn’t do before. And this is what we hear from every investigator that microdystrophin is, I think, a surrogate for propensity for functional benefit. But ultimately, the functional benefit has to be there. And we intend to back that up with our data.

We think we have a unique differentiated construct, and we think that that can lead to better functional outcomes than what’s available today.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: So I do want to touch a little bit on, obviously, there are some reimbursement hurdles, though relative to the cost of these therapies, relatively modest, but real, as you mentioned.

Mitchell Chan, Regenexx Bio: Mhmm.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: Talk about what you can do as now in development and also in the early days of launch to position yourself to have the lowest hurdles reasonably possible, for what is admittedly still a complex therapy. This is not a pill.

Mitchell Chan, Regenexx Bio: I think this is where being a fast follower is a huge advantage. So one of the initial constraints were just these sites were normally running clinical trials. They weren’t delivering commercial material. So now there will be two years of experience delivering commercial material. So I think really just working through the logistics of supply, working through reimbursement, all of that ground will have been paved.

And now we can take advantage of those learnings and incorporate them into our launch to be as fast as possible. I think also having really, really significant inventory of product available at the time of launch, again, the prevalent market from Sarepta’s own statements will be available until 02/1930. There has to be some constraint in there. Drug supply may be one of them. We’re not sure.

But we’re intending to make sure that’s not a factor.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: Great. We have run over time. That’s my fault.

Mitchell Chan, Regenexx Bio: Thank

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: you again. It’s been a really great conversation.

Mitchell Chan, Regenexx Bio: Thank you for having me.

Mani Frohar, Senior Analyst, Direct Medicines, Leerink: Looking forward to a lot of news this year.

Mitchell Chan, Regenexx Bio: Appreciate the time. Thank you for having us.

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