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On Wednesday, 04 June 2025, Viridian Therapeutics (NASDAQ:VRDN) presented at the Jefferies Global Healthcare Conference 2025. The company highlighted significant advancements in its lead program, VRDN-001, for Thyroid Eye Disease (TED), alongside regulatory progress and future commercialization strategies. The discussion was marked by optimism regarding VRDN-001’s potential market impact, although challenges such as market competition were acknowledged.
Key Takeaways
- Viridian is confident about VRDN-001’s market potential, citing positive Phase 3 data and FDA breakthrough therapy designation.
- The company plans to file for FDA approval of the IV formulation soon, with a commercial launch anticipated in 2025.
- SubQ formulation, VRDN-003, aims to offer convenient dosing options and expand the patient base with self-administration possibilities.
- Viridian anticipates entering the commercial market in 2025, leveraging the TED market’s structure to compete with TEPEZZA.
- The FcRn program is progressing with expected IND filing by the end of 2024.
Financial Results
- Viridian expects to become a commercial entity in 2025, contingent on FDA approval of VRDN-001 IV formulation.
- The company projects the Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy markets to reach $9-10 billion in the coming years.
- Viridian sees the existing commercial insurance coverage for TEPEZZA as beneficial for educating the market.
Operational Updates
- VRDN-001 (IV):
- Phase 3 chronic study follow-up is required before filing for approval.
- The active study is complete, with 52-week data available.
- FDA breakthrough therapy designation was granted based on rapid treatment effect.
- VRDN-003 (SubQ):
- Phase 3 trials are ongoing in the US and Europe, with data expected in the first half of 2026.
- The trials are testing Q4 weekly and Q8 weekly dosing regimens.
- FcRn Program:
- Healthy volunteer data for the Fc fragment program is expected in Q3 2024.
- An IND filing for the half-life extended FcRn program is anticipated by the end of 2024.
Future Outlook
- Viridian plans to file a Biologics License Application (BLA) for VRDN-001 (IV) soon, with a PDUFA date expected in 2026.
- The company aims to integrate the SubQ program with the IV infrastructure upon approval.
- VRDN-003 SubQ data is expected in the first half of 2026, with a BLA filing by the end of 2026.
- Differentiation in dose levels and administration routes is a focus for the FcRn program.
Q&A Highlights
- Comparison to TEPEZZA: VRDN-001 is believed to offer better efficacy, particularly in diplopia resolution, and a potentially improved safety profile.
- SubQ Dosing: Trials will evaluate both Q4 weekly and Q8 weekly dosing, with promising PK modeling results.
- Market Dynamics: Viridian views the TED market as an opportunity to compete directly with TEPEZZA.
- TEPEZZA Sales Decline: Attributed to delayed chronic data affecting payer reimbursement.
- Infusion Center Dynamics: Different from oncology, ophthalmology prescriptions are typically referred to independent infusion centers.
Readers are invited to refer to the full transcript for more detailed information.
Full transcript - Jefferies Global Healthcare Conference 2025:
Mike, Interviewer, Jefferies: Alright. Good morning, everybody. Welcome to the two thousand twenty five Jefferies Global Healthcare Conference. I’m really thrilled to kick off the morning with the team at Viridian. Up here on the, platform, we have the CEO, Steve Mahoney, and the chief business officer, Sean Wu.
It’s been exciting times for Viridian. You guys are super busy, obviously, finishing up all of the phase three studies and filing to the FDA. So maybe I would just love to give the opportunity to Steve, maybe just talk a little bit about, obviously, where you are with your lead program in TED with IV, and then obviously execution on SUBQ, and talk a little bit about what’s going on this year and the milestones, and what we should be looking forward to that is important this year.
Steve Mahoney, CEO, Viridian: We do think that breakthrough therapy designation could improve our chances for getting that. And that would be really exciting because we could get our launch going.
Mike, Interviewer, Jefferies: Just a couple of
Steve Mahoney, CEO, Viridian: things about the data from phase three. A couple of standouts. The main endpoints for trials were proptosis response, is bulging in the eyes. We want to reduce the bulging. Clinical activity score, which is a proxy for pain and inflammation.
And then finally diplopia or double vision. As you can imagine from a patient perspective, proptosis and diplopia are the two biggest concerns. What do they look like? And whether you have double vision, double vision impacts. You can imagine a number of things with respect to reading, writing, driving, working.
These are primarily women in their forties and fifties who are impacted by this disease. So they have full lives of families and work. And so to have those types of symptoms can be quite debilitating. So we’re very happy with the results because we showed very good improvement in not only responder to diplopia, but complete resolution of diplopia. And then proptosis, we were very much in line with current standard of care except that we had we’re able to show a rapid treatment effect.
In fact, after just one infusion, we were seeing a majority of patients achieve proptosis response, which is something people hadn’t seen before. So that was fantastic too. So the data looks great. We’re moving on. We did just recently push out put out there was one question that was overhanging, obviously, when you put out top line data.
Well, what is the durability of that response? What’s gonna be the durability of that treatment effect? So we just put that data out several weeks ago and that was seventy percent of people who had a response at week fifteen were able to maintain that response at forty weeks post infusion or last infusion.
Mike, Interviewer, Jefferies: How does compare to Amgen’s TEPEZZA?
Steve Mahoney, CEO, Viridian: Yeah. So in their label they have a fifty three percent rate. Again, ours was seventy. Theirs is out to seventy two weeks. So fifty one weeks post infusion and ours is forty weeks post the last infusion.
Mike, Interviewer, Jefferies: Okay. So if you compare side by side cross trial with all the caveats, but that’s what we have to go on. You believe that your efficacy is in various components of that are the same or in many cases better, particularly on diplopia. That’s an important part. And then on safety, you believe that in both studies you’ve shown lower rates of hearing impairment.
And that may have driven why you, well, don’t know, you tell us why the FDA gave you breakthrough therapy? Because that was actually was quite a surprise. Were just trying to read into, what you filed on and was there something specific? Did like, they don’t communicate to that or they just give you breakthrough and they send you a letter? Like, just trying to think about what what they saw there.
Steve Mahoney, CEO, Viridian: Yeah. That’s right. They they don’t pinpoint exactly why they granted breakthrough, but the request for breakthrough was based on, two key elements. The rapid treatment rapid onset of treatment effect. So again, we were seeing a majority of response after just one infusion and then the diplopia response and resolution where our numbers, again, cross trial comparison, but that’s exactly what they do in breakthrough.
So they looked at the diplopia resolution rates for TEPEZZA were essentially negligible. Was 3% placebo adjusted where we were closer to 20% placebo adjusted for complete resolution of diplopia. So that’s a meaningful difference. We saw that in both, that was particularly true in the chronic population. And then we did see a 15 delta in the active population as well.
So really, really strong diplopia data. So, again, they don’t tell us what what they based it on, but that was what the request was based on.
Mike, Interviewer, Jefferies: And the safety.
Steve Mahoney, CEO, Viridian: Yeah. The safety is safety is part of it. Hearing impairment is the is the AE of interest in this in this class. And we did, as you pointed out, we have lower rates of hearing impairment than they did.
Mike, Interviewer, Jefferies: Okay. So what are are is the gating step to filing this year? Like, what what what needs to happen and how fast can you file assuming you could get priority review? But we wanna start by filing.
Steve Mahoney, CEO, Viridian: Right. We’ve been very consistent on our guidance. It has not changed over the past year. We need the chronic study follow-up period to complete before we can file. And so we’re just waiting for that process to finish.
We’ve already finished, as I mentioned, because we have our durability data. We already did finish the active study, the Thrive study, and we were able to get that fifty two week data out. But we are still in the process of of patients in the fall.
Mike, Interviewer, Jefferies: Do you need to have, like, a pre BLA meeting? What are the FDA interactions over the past six months and going forward? Do have to have a pre BLA meeting, etcetera? Obviously, there’s changes at the FDA. I’m sure everybody knows Marty Makary will be here later today, so maybe we’ll ask him.
But in all seriousness, you have a group that you work with in that And obviously, we’re just trying to figure out how the interactions are going and whether you feel like this should be pretty straightforward. I would agree that the breakthrough therapy thing was interesting. Seems to go a little bit missed, I thought that was interesting. So
Steve Mahoney, CEO, Viridian: Yeah. So we are in the ophthalmology division. We’re under CEDAR. The our ophthalmology division appears to be completely intact. The leadership is there.
Our review team is there. We in fact had, as part of the breakthrough discussions, we actually had a face to face meeting down at FDA, which was great.
Mike, Interviewer, Jefferies: Who do you meet with there? Is that someone in the ophthalmology division?
Steve Mahoney, CEO, Viridian: Or Yeah. Ophthalmology division. Billy Boyd was in the room. He’s the he’s the I think he’s considered the director of that division now since Wiley Chambers left. But the main point is that the ophthalmology division is intact.
Our Our engagement with them has been great, and we feel we are aligned
Mike, Interviewer, Jefferies: Right, because Wiley moved on, and so whoever He retired. You did have a meeting with them. Yes. Okay, good. Yep.
Okay. All right, so then there’s two topics that we should also cover coming up. So one is when you get that filed, you could have priority review. There will be a presumably a PDUFA date in 2026. We look forward to that.
Yeah. And then, obviously, you’re trying to finish up execution on the sub q. Right. So there’s two parts there. One is, like, to the extent that investors should be excited in valuing the commercial opportunity for IV, but then literally a year or so after that, here comes SubQ.
So maybe we take that in two steps is where are you with SubQ? What needs to happen? What do you expect out of those results? Yeah. Those are important questions.
Steve Mahoney, CEO, Viridian: Yeah. No. And I
Mike, Interviewer, Jefferies: think That’s that’s a whole step up over IV.
Steve Mahoney, CEO, Viridian: No. That’s exactly right. So I think you’re you’re setting it up the right way. In fact, in the with the fact that we will be a commercial company next year is our expectation. The data’s very solid and in our alignment with the FDA there.
So we we do expect to be a commercial company. It’s just a matter of when on IV. And and then the subcu program is currently enrolling two phase three studies, active and chronic studies. That is all on track with our guidance, which is data in the first half of twenty twenty six. And then we expect to file a BLA at the end of twenty twenty six.
So we’re about a year behind.
Mike, Interviewer, Jefferies: So, yeah, so in terms of completion of enrollment, what is the where are you with those two studies, and how’s that going, and and all that kind of stuff?
Steve Mahoney, CEO, Viridian: Yeah. We are on track with with everything. The study is exactly on track where we want to be, which is obviously a great sign. And again, we’ll have that data in the first half of twenty six.
Mike, Interviewer, Jefferies: Just to be clear, there’s timing for the data in the first half of twenty six, right? So not timing for completion of enrollment. Yep. You can do the reverse math.
Steve Mahoney, CEO, Viridian: Yeah. You’re gonna have to do the reverse
Mike, Interviewer, Jefferies: You could be guided to that. But Alright. Would you announce when you complete enrollment, or that’s an earnings call thing? Or
Steve Mahoney, CEO, Viridian: Yeah. Maybe.
Mike, Interviewer, Jefferies: Milestones in the next few months.
Steve Mahoney, CEO, Viridian: Yeah. We we would consider announcing that depending on what’s going on. But yeah.
Mike, Interviewer, Jefferies: And there’s there’s two studies. Are they exactly duplicate? Or they there’s there They’re by regions or what?
Steve Mahoney, CEO, Viridian: They’re staggered. They’re both in US and Europe.
Mike, Interviewer, Jefferies: Okay. Staggered meaning that one will finish up later on?
Steve Mahoney, CEO, Viridian: Yeah. One will finish first. Alright.
Mike, Interviewer, Jefferies: And what do you expect out of the results? Do you think that the results should be essentially identical on all of the efficacy and safety endpoints cross trial to your own IV. Do you believe that perhaps based on the administration as a subQ that perhaps there could be better side effects because of hearing loss. There’s different hypotheses as to how hearing loss comes about. So maybe with the sub q you’re blunting the Cmax or maybe that’s an interesting angle.
I actually don’t know. What do you think would happen with the efficacy and safety of the sub q data coming?
Steve Mahoney, CEO, Viridian: Right. So Sean’s gonna take this one.
Sean Wu, Chief Business Officer, Viridian: Yeah, it’s a really good question. I think it’s worth, taking a little bit of a step back and, discussing a bit about why we’re so excited about the subcu program. The VRDN003 program, the antibody portion or the molecule I should say, shares the same binding domain and CDRs and will interact with the target of IGF-1R in the same way as the VELI IV molecule. But we’ve engineered the three molecule to have a extended half life which we confirmed, earlier, back in 2023. That data allowed us to take this straight into a phase set of phase three studies, that was aligned with the FDA, to test q four weekly and q eight weekly, dosing regimens for, three.
Mike, Interviewer, Jefferies: Both a month or once every two months.
Sean Wu, Chief Business Officer, Viridian: That’s right, exactly. We think both of these would be exceedingly convenient for patients and would be a game changer from a dosing and administration aspect for patients. These would, we would anticipate to be self administered auto injector pens that would be mailed to the patient at home with at home administration, which if you look at a number of analogs with sub q administration that can expand significantly expand the number of patients that are actually treated because of that increased access without having to go to an infusion center. Now coming back to the shared pharmacology with our IV molecule with veligritag back when we put out that data in healthy volunteers confirming the half life in 2023. We also did PK modeling showing that Q4 weekly and Q8 weekly, the exposures associated with three in both of those two regimens matched back to the exposures we saw with VELI IV in a Phase two study that we had at the time.
Q4 weekly was achieving Cmin levels looked really great in terms of exposures of ten mgs per kg IV from that phase two study. And then Q8 weekly was showing that it achieved the Siemens of three mgs per kg IV. Now ten mgs per kg IV obviously we just showed in THRIVE and THRIVE-two really fantastic efficacy and safety data. So, we’re really excited about the potential for the Q4 weekly arm. But now the Q8 weekly we were pleasantly surprised that it was able to exposure wise match back to three mg per kg IV because that three mg per kg IV dose arm in the VELI study, small patient numbers acknowledged that but showed very, very great and robust clinical activity across all of those parameters of proptosis, CAS,
Mike, Interviewer, Jefferies: and the It’s interesting because your one question is ten mgs per kg is the dose you’re using in IV. And it’s interesting because three mgs per kg IV did show similar efficacy as ten mgs. So from a FDA minimally effective dose concept, your phase threes didn’t use three mg at all in any of the arms. Is that correct? They were ten mg.
Sean Wu, Chief Business Officer, Viridian: That’s right.
Mike, Interviewer, Jefferies: Yeah. Now there’s no real safety concerns. In fact, safety looks pretty good, so they wouldn’t really need yeah. Like in other indications, they want you to find the lowest effective dose that’s safe. So there’s no issue there.
But three mgs did look basically the same. And so when you do your sub q, you’re using a once a month that literally looks identical in exposure to the ten mgs, And then a once every two months, which looks like the exposure of the lower IV dose, which also looks like the high. So you’re covering both. And so either one, they could look identical. One could look a little bit lower, but not clinically meaningfully different and give someone once every two months.
How do you think about those scenarios? Obviously a win is they both look identical. One win is one looks a little bit better than the other but both could be approved. How do you think about those?
Sean Wu, Chief Business Officer, Viridian: Yeah, we think both of those are derisked and we’ll make decisions on which dose to take for once we see the data. But from both of those dosing regimens being derisked standpoint and the fact that the Q8 weekly at a lower set of exposures could match the efficacy that we have seen or come to expect with IGF-1Rs but with the lower exposures lead to an even better safety profile, that’s a really exciting potential for outcomes.
Mike, Interviewer, Jefferies: And how do we look at that? Because they’re obviously not going to be statistically compared to each other, but they would be each arm would be compared to placebo. Now if you go back to some of these nuances, which I don’t have time to go into, you’re more than well powered, because I think the number of patients in there is like almost larger than the IV per arm. So that shouldn’t be a concern. So you have more patients per arm in each of those, so you have more powering than the IV.
And if the once every month is identical to the IV, that’s a huge win because now you have a once every month sub q. And if the once every two months look similar and beats placebo, that’s significant, That’s a huge one.
Sean Wu, Chief Business Officer, Viridian: Yeah, these are all great profiles to have and at the end of the day what we’re really excited about for both of these is the fact of the self administration so we can mail these to patients and they can self administer at home which will greatly expand the patient population that, would, be motivated to take an IGF one r.
Mike, Interviewer, Jefferies: I I gotta be honest. I don’t actually know, how I would characterize Wall Street’s expectation. Wall Street’s expectation is like, hey. If one of those arms win, presumably, monthly, you have a huge opportunity because you have a once a month sub q. If once every two months hits statistically significant, I certainly don’t think Wall Street’s really thinking about that.
That would be huge showing where the valuation is. And if both of them hit and they both look identical, would you just file both and try to get both in the label? That’s an interesting question.
Sean Wu, Chief Business Officer, Viridian: Yeah, we haven’t gotten into those details yet, so let’s see what the data shows. But either one of those dosing arms we think would be a game changer for patients. I
Steve Mahoney, CEO, Viridian: was going to say the same thing.
Mike, Interviewer, Jefferies: Certainly we’ve to have positive data. The second one is also positive, the once every two months arm, I don’t think anyone thinks that is even that’s even even talked about. So then let’s say they are positive and the IV is getting approved and 2026 could be a huge setup because you could be an approved company and have this data in hand. People look at the TEPEZZA sales from Amgen, which I cover, and the sales are declining year over year. So what do you believe, based on your we have our own checks too, and we’ve heard different things.
But what do you think is going on out there to explain the sales of the drug which has a monopoly, TEPEZZA has a monopoly, and the sales are declining year over year? What do you think is the issue, and why do you think Viridian would be able to change that?
Steve Mahoney, CEO, Viridian: Well, I think, first, kinda hard to comment on another company’s execution and and that type of thing. But, you know, if you if you look back at it, what Horizon originally ran, they did not run when they were developing the drug, they ran active studies only.
Mike, Interviewer, Jefferies: Mhmm.
Steve Mahoney, CEO, Viridian: It wasn’t until after approval where they seemingly got pushback from payers that there was no chronic data for payers to look to. So they weren’t getting their reimbursement out of on day one.
Mike, Interviewer, Jefferies: Mhmm.
Steve Mahoney, CEO, Viridian: And it took them several years. In fact, they didn’t even run a chronic study until eighteen months after approval. So that that data got generated late in the game. On their last conference call, they they said they made a big jump because all of last year they had a commercial insurance coverage of about $50.55 percent in The US. And then on the last call, just a few weeks ago, they are they mentioned that they had broken through and gotten up to 85%.
All of this is great for us because all they’re they’re educating. We we every all the work that they do is great for us and great for patients, most importantly. Right? Because there’s an education campaign for patients. There’s an education campaign for physicians, all with respect to IGF-1R.
But there’s also education of IGF-1R for payers. And so these advancements that they’re making with with payers, particularly in the chronic population, is great for us because, again, we have that data on day one. And our data looks, again, trial comparison,
Mike, Interviewer, Jefferies: but it
Steve Mahoney, CEO, Viridian: looks looks favorable to us. And the key for all of this is that this is a new start market. Right? And so for all of those groups I just mentioned, patients, physicians, payers, every time a patient comes in to see a physician because of their symptoms, the bulging of the eyes, the double vision, the pain, often described as having a grain of sand under your eyelid and you’re just constantly trying to get it out. So you can imagine how miserable that is.
Someone comes in with symptoms, we don’t have to get them to switch off of TEPEZZA. We don’t have to get them to switch off of anything because when they come in and they say, what are my options, my treatment options, and we’re on the market and we can say the physician can say, hey, look, I can get you, again, cross talk comparison, but it looks like a better clinical outcome, at least as good if not better clinical outcome. But, I can do it with five infusions versus eight. So ours is five, theirs is eight. Ten mgs per kg versus their twenty mgs per kg, thirty minute infusion time versus their sixty to ninety minute infusion time, all the things we talked about with the differences in the data.
And if we win that conversation right there, we can shift the revenue stream right then and there to to vilagratime. So that is that is a great market dynamic for us to walk into. And to your question about, you know, their sales in in their record over the last several quarters, Don’t forget, TEPEZZA is a six month regimen. I mean, is six months of going to infusion centers. We are coming in and we’re gonna reduce that to three months.
So that’s gonna be really attractive, we think, to patients and physicians. And importantly, in the infusion centers, we’ll turn the chairs over fast.
Mike, Interviewer, Jefferies: And by the way, most of these doctors that are prescribing, they do not have in house infusion centers. Or some people say the doctors have economic incentive to treat at their own facility because they want to keep the patient, see them once every three weeks. Yeah. Every three I recall. And so therefore they’re making money and seeing the doctor of the patient every three weeks and they’re getting paid to do the infusion.
The infusion is not at their center. It’s at some other center which they have no economic ties to. Is that true?
Steve Mahoney, CEO, Viridian: Right. Yeah. So in oncology you’ll have those types of economics where there’s incentives for physicians to hold patients on a particular drug because they they benefit from it financially in their own infusion center. Yeah. Ophthalmology just they don’t have their own infusion centers and they are primarily the prescribers.
Right? So even endocrinology will, when they see the eye manifestation, will say, hey, you need to go see a neuro ophthalmologist or an ocular plastic surgeon or even your ophthalmologist. And the the ophthalmology side of the world writes the prescription, but they send you down the street to an independent infusion center. So those market dynamics of keeping loyalty to a
Mike, Interviewer, Jefferies: particular brand is not That’s so there’s no economic benefit.
Steve Mahoney, CEO, Viridian: There’s no economic benefit.
Mike, Interviewer, Jefferies: Yeah. Okay. So, look. If we can, get filed and get approved next year and then also the sub q data is coming next year
Steve Mahoney, CEO, Viridian: Yeah.
Mike, Interviewer, Jefferies: That’s a huge setup. Right. It’s a big 2026 for you on that front, and that’s that’s ahead on Ted.
Steve Mahoney, CEO, Viridian: Yeah. That’s right. Exactly. So I think key takeaways here, we’re gonna be a commercial company. We’ve got an opportunity in a new start market to to grab meaningful share of patients we think are going to be more convenient.
We think we’ve got better we’ve got some differentiated data. And then subcu will plug in nicely to the IV infrastructure we’re going to build this year.
Mike, Interviewer, Jefferies: Yep. So while that’s happening, and, yeah, I just wanna emphasize because we were a pleasure. The breakthrough therapy thing that just happened and also the durability of it. All that was sort of just reported in the last couple
Steve Mahoney, CEO, Viridian: And and I think that was the key.
Mike, Interviewer, Jefferies: Been a a bit under not as appreciated because there’s so many other things going on macro wise with the sector. Just wanted to say that that that that was interesting. So maybe in the last couple minutes, again, think not talked about a lot, is you are pushing forward with a FCRN program. Yes. And so maybe you could spend just the last couple of minutes perhaps teasing us with where you are with your FCRN.
Now you kind of have like, feel like two different programs. One is a more straightforward one and then one could be a long acting version. Can you just remind us where you are with those? Are you trying to do both? Or where what is your strategy with FcRn?
Steve Mahoney, CEO, Viridian: Right. So the first program is an Fc fragment, very much like Vivgart. It’s a similar approach. We believe, as far as we know, we are the only other Fc fragment in clinical development. Everything else is full length antibodies or degraders or that type of thing.
We like the fragment. Vivgar, we believe, is still the gold standard from an efficacy and safety perspective. And, obviously, these are big markets to operate in. The first two markets, MG and CIDP, are projected to be $910,000,000,000 over the next several years. And then there are, according to some, there are another 75 indications that should be addressable by FCRA.
So these are large markets with with lots of opportunities. We like the fact that we’re the only other fragment, be because of the profile that Vivgart’s been able to create. That is our first program. We have healthy volunteer data coming out q three this year. The reason healthy volunteer data is important in this world is because it confirms everything you really want to know.
It confirms IgG suppression in even though it’s in healthies, it has been proven to be highly translatable to disease patients. So IgG suppression thresholds, we want to see that. We want to see
Mike, Interviewer, Jefferies: what level do we want to see? Because people cite different numbers. But what do you want to see in healthies?
Steve Mahoney, CEO, Viridian: We want to we want to hit that Viv Gard range of 65%.
Mike, Interviewer, Jefferies: Sixty, sixty five % reduction. Yeah.
Steve Mahoney, CEO, Viridian: And that’s just in the range of of Vivgart. So if we can replicate that, that’s a great sign. Obviously, you want to be albumin sparing so you’re not seeing those LDL spikes, which is what they saw with the tokamab. And and then finally dose. So we’ll figure out some dosing information on this.
Mike, Interviewer, Jefferies: How are you differentiate with this one versus Vivgar?
Steve Mahoney, CEO, Viridian: Well, we have some ideas as to how that could play out. I think we would wanna see the data, and then we’ll come out with the data and say, here’s where we can we can be differentiated.
Mike, Interviewer, Jefferies: Is it gonna be faster onset, faster drops? Is it better dosing? Just like because I I I’m not exactly sure.
Steve Mahoney, CEO, Viridian: Right. Well, we’re looking at
Mike, Interviewer, Jefferies: Investors are not sure.
Steve Mahoney, CEO, Viridian: Yeah. We’re looking at we’re looking at frequency. We’re looking at dose levels. We’re looking at route of administration, all those things be differentiated. But we do like the performance of the fragment.
So that’s the first program. And the second program is, as you mentioned, is a half life extended version of that. It’s a it’s an albumin binding domain that allows us for that half life extension. It’s very similar to argen in that case, I mean, we came out first, but argenx does have a similar concept in development as well. And we’re neck and neck on time.
Mike, Interviewer, Jefferies: Yeah. They have phase one data first half twenty six.
Steve Mahoney, CEO, Viridian: Right. And we have an IND filing at the end of this year.
Mike, Interviewer, Jefferies: Okay. So we’re right behind. That far behind? Yeah. Okay.
Okay. Fantastic. Well, thank you guys very much. So we’ve got some FcRn data coming later this year. I didn’t appreciate that.
You obviously have a big 26 with with Ted. And I feel like, you know, it’s been a bit of a tough biotech tape. But, obviously, this sets up quite well for some big events just around the corner.
Steve Mahoney, CEO, Viridian: Yeah. Yeah. Thanks for having us, Mike.
Mike, Interviewer, Jefferies: Very good. Thanks. Thank you, guys. Thank you very much.
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