Travere Therapeutics at Canaccord Genuity: Strategic Insights from Growth Conference

On Wednesday, August 13, 2025, Travere Therapeutics (NASDAQ:TVTX) participated in Canaccord Genuity’s 45th Annual Growth Conference. The discussion, led by Senior Biotechnology Analyst Edward Nash and Travere’s CFO Chris Klein, highlighted the company’s strategic focus on its key assets, Filspari and pegtobatinib. The conversation covered both promising developments and challenges, including regulatory milestones and market expansion plans.

Key Takeaways

• Filspari is positioned as the only non-immunosuppressive therapy fully approved for IgA nephropathy.
• Travere has submitted a supplemental New Drug Application (sNDA) to modify the REMS for Filspari.
• The potential market for Filspari in FSGS is larger than that for IgA nephropathy.
• Pegtobatinib is advancing towards Phase III trials for classical homocystinuria (HCU).
• Travere plans to expand its sales force to include pediatric nephrologists.

Filspari Commercial Uptake and Strategy

Travere aims to establish Filspari as foundational care in IgA nephropathy. Since its accelerated approval in February 2023, Filspari has seen consistent uptake, with patient start forms increasing from 500 to 700. The broader label now allows treatment for patients at risk of progression without a proteinuria cutoff. Payer coverage is robust, with 96% of patients having access or a pathway to access Filspari. The reimbursement timeline has improved, trending towards the lower end of the 20-60 day benchmark.

Filspari REMS Modification (sNDA)

The sNDA aims to modify the REMS for Filspari, transitioning from monthly to quarterly liver monitoring, with a long-term goal of removing the REMS entirely. This change aligns with clinical trial protocols and aims to improve patient convenience. The PDUFA date for this modification is set for August 28th.

Filspari Potential Label Expansion for FSGS

The potential label expansion for Filspari in FSGS, with a PDUFA date in January 2026, is a significant focus. The PARASOL workshop findings, which involve FDA and EMA input, support the use of proteinuria as an endpoint. The Duplex data shows strong responses to Filspari, with significant proteinuria reduction. Travere plans to expand its sales force to include pediatric nephrologists to effectively commercialize Filspari for FSGS, if approved.

Pegtobatinib (HCU) Update

Pegtobatinib, an enzyme replacement therapy for HCU, is progressing towards Phase III trials. The program addresses a significant unmet need, with 7,000-10,000 patients in the US lacking disease-modifying therapies. The goal is to replicate promising Phase I/II results, focusing on reducing total homocysteine levels.

Future Outlook

Travere Therapeutics is optimistic about its regulatory milestones and potential market expansions. The company is focused on achieving full approval for Filspari in FSGS and advancing pegtobatinib’s Phase III program. These developments, alongside strategic sales force expansions, position Travere for potential growth in the coming years.

For more detailed information, please refer to the full transcript below.

Full transcript - Canaccord Genuity’s 45th Annual Growth Conference:

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Hi. Good morning, everyone, and thank you for joining us. My name is Edward Nash, senior biotechnology analyst on the equity research team at Canaccord Genuity. I have the pleasure of having with us today, Trevere Therapeutics. With us from Trevere, I have Chris Klein, who’s the chief financial officer.

Thank you very much, Chris, for joining us. Thank you for having us. So maybe as we to start off, if you could maybe just give us some background for our audience on what exactly is that Trevier does and and then just the kind of clinical trial focus the company has.

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. So for those of you that don’t know Trevere, we are a biotech company based out of San Diego, and we are exclusively focused on identifying, developing, developing, and delivering life changing therapies for people living with rare disease. Core to our focus is rare nephrology and rare metabolics. Really at the heart of our efforts is Filspari, which is the only dual endothelin angiotensin receptor antagonist that is approved for IgA nephropathy and in development for FSGS, two rare kidney diseases. Both are leading causes of end stage kidney disease or kidney failure.

And we also have a program called pegtobatinib that is an enzyme replacement therapy that we’re looking to begin enrollment next year in our phase three study. And that’s looking to be the first potentially disease modifying therapy for something called classical homocystinuria or HCU, where there’s currently no real therapies that are disease modifying or that are really benefiting patients. So we’re in the early stages here of being able to help patients and looking forward to a very exciting second half of the year.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Fantastic. So Filspari received accelerated approval in February 2023. So the drug has been on the market now for about two point five years. Can you talk a little bit about the commercial uptake? And have there been any major changes from what you initially planned with your commercialization?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. So from the outset, goal with Filspari has always been to enable it to become foundational care in IgA nephropathy. And if you think back to February ’3, when we gained accelerated approval, we were the second therapy that was approved, the only non immunosuppressive therapy at the time. And you had physicians that knew to treat their severe patients, but were still learning how important it was to treat those patients with lower proteinuria. And under accelerated approval, all therapies have a little bit narrower label.

So they’re labeled for generally one point five grams and above. So during that period, as you might expect, you have the initial blocking and tackling of your commercial launch where you’re working through reimbursement, you’re working through the fulfillment process and getting your therapy out to patients. And you’re also building that experience with physicians and patients. And so what we saw in that initial period was a very nice uptake, very consistent with what our expectations were and setting that foundation for becoming the new treatment standard. And we were able to outperform all the benchmark launches in the recent renal space.

And so what we really looked to do was leverage that experience when we got to full approval, which was September, to go from roughly 500 PSFs or patient start forms in demand up to what is now the new baseline of around 700 patient start forms in demand. A nice jump. And really that’s been driven by the fact that we now have a broader label that is for patients at risk of progression. So there’s no more cutoff of 1.5. And then we’ve also seen a nice evolution in the guidelines, which has helped not only drive physicians to be more ambitious in how they’re treating their patients, but also places feel sparring as foundational care and is really changing how people are thinking about things going forward.

So we’ve seen a nice acceleration now in full approval, and we’re looking forward to a strong second half.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: So you’ve talked about the new patient form. So we obviously hear a lot about that every earnings call because that’s really a good guide as to what uptake is looking like. Could you speak a little bit about reimbursement? How long does it normally take for a patient to complete that form before the drug actually gets in their hands? And how has that changed and evolved since initial launch?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. So as part of our strategy, we had always planned to have broad access for Filspari. So that started prior to launch when we were engaging with payers. It continued with our pricing strategy at launch, and it continues today with continuing to engage with payers and making sure that the updated label is reflected and we have strong access. And we’ve been very pleased with the progress.

So when you think about our payer coverage, we’ve got ninety six percent of patients with access to or a pathway to access. And we have seen a nice transition of payers reflecting the updated label. So that’s all gone very well. To your question on sort of the timeline and how that’s evolved, our Chief Commercial Officer, Peter Haramat here, typically talks about his benchmarks being the twenty to sixty day timeline. And as you would imagine, early in the launch, you start at the further end of that as you’re still working through the reimbursement process, getting the payer coverage plans in place, getting the infrastructure up to full speed, etcetera.

And we’ve seen that consistently go towards the lower end, and we’re continuing to invest there and continuing to see improvement every quarter. So things are moving very well.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: That’s great. So you have a supplemental NDA in front of the FDA with a PDUFA at the end of this month. Can you remind us of the supporting evidence that led to the filing? And you feel about how you feel about the outcome as far as getting this the REMS right now modified?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. So the sNDA that you’re referencing, for anybody that may not know, is an sNDA to modify our REMS for really two purposes. The first is to remove the embryo fetal toxicity monitoring from the REMS. That’s a class based change that FDA had communicated to us along the way. And so we included that in our request for the sNDA.

And so we would expect that to just go into the normal labeling aspects. And then the second is around liver monitoring. And the way that Pilspari is currently structured, the REMS is currently structured, is that patients have to do monthly monitoring for the first year and then transition to quarterly monitoring after the first year. Our request to FDA and the CSNDA is to have quarterly monitoring upfront and have that be the way throughout treatment for patients. And really, the rationale behind that is that’s how we study the drug.

So we did quarterly monitoring in our clinical trials. But also it aligns very clearly with how patients are normally getting their labs. So it makes it convenient and aligned very well with their normal cadence of their doc visits. So in terms of the evidence, there are a host of things that we included in our sNDA. The first and foremost would be our clinical trials.

So in our clinical trials we show that Vilspari had comparable ALTAST elevations relative to irbesartan, the active control. And that is in both IgA nephropathy and also in FSGS where we trialed double the dose. And we have had no cases of Heis Law or any kind of elevated ALT AST associated with bilirubin, etcetera, in the course of the program. So that’s one aspect of it that has been very consistent. And the other now that we’ve been able to strengthen that submission with is real world data.

So as we talked about earlier, VILSPARI has been approved for some time now, and we’ve been able to capture that data in the real world setting to show that there is there have been no cases of Hy’s Law and that we’re seeing that the monitoring that that has been in place has been more than adequate, but that it can go to quarterly. And and to your point, we expect that to be the case when we when we get to the PDUFA date of August 28.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: And and is the expectation over time is to get the rims removed entirely, and this is just the first step towards that? Or is it just something that will likely need to stay and it made it easier obviously being on the same schedule as what a patient only does their lab work?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. Having it on the same schedule is certainly going to be helpful. But our goal is to ultimately have it removed. It’s always been a two step process. So first, this one is to modify it to that quarterly and get it into the normal cadence of things.

But ultimately, we believe that we have the data and we will have the data to get it removed. And so we’re going to continue to have that dialogue with FDA. Historically, they’ve been anchored on our post marketing requirement, which is 3,000 patients for two years. But we’re going to continue to engage with them to see how quickly we might be able to get it removed.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Is this more about making the burden easier on the patient? Or does this actually, with having a REMS in place, tend to deter some physicians from using the drug?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Yeah. I don’t think it’s had a big impact on physicians. For physicians, it’s relatively straightforward. You go through, you certify that you have read the REMS documents and the label. It’s a relatively quick process.

I think where we are expecting the most benefit is from it’s really convenience for patients. And there’s probably a small segment of patients that are either lower in their proteinuria or they have very busy lives that just think about it. A monthly monitoring is something that may be too onerous. And for those patients, we think that it will open it up a bit and fall right into that normal cadence of things.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Understood. And now with the IGAM development landscape has changed dramatically in commercial landscape in a very short period of time, and it’s gone really from zero to 60 over the past several years, I think, with Tarpeo’s approval and then and then Filspari, and then we’ve had a couple of approvals since then. Could you maybe talk a little bit about the more recent approvals in the space, Tepalta and Venrafia? And just has that in any way impacted how you’re approaching the market from a commercial standpoint with Filspari?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. Well, it’s an exciting time to be in IgA nephropathy for sure. We’ve been very pleased with our progress with Filspari. And we just reported second quarter results last week. And there we reported all time highs for both demand and revenue.

So we’re doing very well on our pathway to getting FILSPARI to foundational care. And we expect that to continue. When we think about the overall treatment paradigm in the landscape, we believe that there is gonna be room for many therapies to continue to grow. Really I say that for two main reasons. One, for IgA nephropathy, we believe that there are more than seventy thousand patients that are addressable, and that’s likely to continue to grow.

And so there are a lot of patients out there that are gonna need help, and we know that there isn’t any one therapy that is gonna get all patients into complete remission. And that’s an important component of where the KDIGO guidelines are headed. The second aspect of that is going back to the KDIGO guidelines. We have the draft form now. We’re expecting the final guidelines later this fall.

But they’re highlighting a few important things, one being getting patients to complete remission or zero point five grams, which is a nice change from where physicians used to be, where they weren’t as ambitious with their treatment and getting patients lower in their proteinuria. And so that’s gonna drive more and more treatment both earlier and then also with utilization of the new medicines including Filspari as we move ahead. But then the other important aspect is that the KDIGO guidelines are highlighting this dual approach of addressing both the over activation in the kidney, which is where Filspari plays, and then over activation immune system, which is where a lot of the other medicines that are coming in development are going to be most active. And so there’s going to be the need for both. And with many patients out there that need help, we expect the market to continue to grow nicely.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: And with Valsparri, does it from the new entrants that are out there, do you have a strong differentiation from those agents? I know you said the market is large enough for multiple competing agents. But just kind of wanting to understand what that differentiation is so that when you’re going in front of that provider, you have that barrier to entry already, right? That you’ve already been out there for a longer period of time Sure. Than what’s out there.

Is there does it require more convincing or more visits as you go to those providers to kind of differentiate them being agents?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. Well, think one of the benefits that we have that you touched on briefly there is that we’ve had Valspara in the market for some period of time. So physicians have already built up that experience. And what we continue to hear as feedback is that the experience they’re having matches what we saw in the clinic. So a rapid and sustained reduction in proteinuria early on when patients start treatment.

So we already have that to be able to leverage. But in terms of thinking about Filspari versus some of the other therapies in development or available, Filspari is the only medicine that can replace standard of care, right? So we’re the only medicine that has been trialed specifically against an active control, RAS inhibitor, and everything else is being used in conjunction with standard of care. And so that’s a unique placement for Filspari. And we’ve also shown we’re the only non immunosuppressive agent that’s approved under full approval for all patients at risk of progression.

So we’ve got the two year data to be able to show that treatment with Filspari translates to long term kidney function preservation, which is very important when talking about the kidney aspect of disease. When I think about the treatments that are coming down the line on the immune side of things, it’s less about advantages and disadvantages. It’s more about where do the synergies come into play, because there are differences between us and the B cells. You think about it as treating the kidney versus the immune system, deposition of IgA versus protecting the nephrons that are still there, etcetera. But most importantly, the B cells, they’re all being evaluated on top of standard care, right?

So that’s what we’re aiming to replace. And the expectation based off of what we’ve developed in our clinical studies and evidence generation beyond that alongside the KDIGO guidelines is going to continue to place us as combination therapy with those in the future.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: That’s kind of where I was going next with April Bliss mechanism of action seems to be what’s up next. They’re in Phase III now that we should see potentially receiving FDA approval. So from what you’re talking about, it doesn’t sound like really positioning of Filspari will need to change at all with the addition of this potential additional April bliss mechanism coming to the market.

Chris Klein, Chief Financial Officer, Trevere Therapeutics: That’s right. Our goal is to have Filspari become foundational care, replace that historical standard of care that has been RAS inhibitors, etcetera. And in doing so, we expect to be utilized alongside those other medicines that are really focused on the more immune aspect of the disease.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Right. So you have another PDUFA date that’s coming up in January 2026, and that’s for it’s very heavily watched by the street for the potential expansion of your label for the indication of FSGS. Could you talk a little bit about Parasol workshop? Because that was obviously extremely important in filing for this supplemental NDA. And just what the implications and outcomes from that meeting have on for a potential approval in FSGS.

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. So Parasol was a very exciting evolution of the field, if you will. Taking a step back and looking first at the membership of Parasol, you’re talking about FDA, EMA, the leading patient advocacy organizations within FSGS, and then glomerular experts throughout the world. So you’re really bringing together the right people to try to solve the question of how do you evaluate FSGS in a clinical setting that’s going to provide a pathway to a potential approval? And what they did was they were able to access 26 different data sets, more than 1,600 patients worth of data, which is, you know, one of the largest collections of data that we’ve seen in FSGS.

And they asked the question, well, is eGFR a feasible endpoint in FSGS? If not, what is? And so the analysis led them to the conclusion that eGFR, while it linked to understanding kidney failure, it’s not viable as a clinical endpoint in diseases like FSGS where you’ve got smaller populations. And the main reason for that is the variability in eGFR measurements in FSGS, and that’s really driven by the waxing and waning nature of the disease. So Parasol then went through the database and evaluated proteinuria and looked at it from a few different perspectives.

One was the biologic plausibility, and it’s very clear that proteinuria has strong biologic plausibility in the causal pathway of FSGS. And then two, it was focused on well what are the thresholds or what do you need to see in reduction of proteinuria to have a clear tie to kidney failure or understanding the risk of kidney failure? And there what they found was that if you can get patients below 1.5 and they pointed to 1.5 to 0.7 and even if you can get them below that, then patients have a far greater chance of avoiding kidney failure. And that was very clear through the data. And so for us when we looked at the PARISOL data and we held it side by side to duplex data, they fit very consistently.

When we think about duplex, our phase three in FSGS that that completed a little while ago, and we look at the threshold, you see as we go down from 1.5 to one to 0.5 to 0.3 of proteinuria that you have a very strong response for filspari versus irbesartan and that actually that signal gets stronger the lower down you go. Furthermore, we reported some additional data earlier this year that shows in our DUPLEX study, you achieved partial remission of proteinuria or complete remission, you had a sixty seven to seventy seven percent chance of avoiding kidney failure. And then we also had additional data that really points to the, you know, with partial remission of proteinuria. No matter at what time point you look at it, we continue to maintain a magnitude of benefit benefit for Filspari versus Irvisartan. Whether it was at any point in time in the study, whether it was at thirty six weeks or whether it was at two years, you had the same magnitude of benefit.

So I think all of those align very nicely to the PARASOL data and to the fact that VILSPARI has been able to show a benefit over an active comparator.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: So I know you mentioned on the call that likely that you’ve been signaled by the agency that they would most likely be having an AdCom Mhmm. For for the syndication, really is typical standard of business. It’s usually very usually unusual not to have one. So I know you guys have been have been preparing for this. Is there anything specific?

Because I I also, as the analyst, completely agree. It seemed like that what Parasol was looking for and what data you had from Duplex did fit hand in glove. But are there is there anything that you kinda feel where the agency is maybe gonna be spending a lot more time now that they’ve they’ve obviously are aware of what came out of Parasol that might be a concern or that might be just something that you know they’re gonna be really kind of focused on?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Sure. So FDA has not yet communicated anything specific to us that they’re planning to cover in the Ad Comm. But based off of all of our interactions to date, I think it’s fair to expect that there will certainly be some conversation of Parasol. That’s a new development over the last year that is shifting how people think about an endpoint that is is changing. Right?

So that will certainly be a part of the discussion. I think another important element that will be covered is putting the duplex data into the context of PARISOL. And I think that’s especially important because our duplex data were not involved or not incorporated into PARISOL. So our data are independent, and this would be the first opportunity for the FDA to really review in that forum the Duplex data and how they match, just as I mentioned, to PARISOL. So I think that will be a key focus in putting that into context.

And it’s really a a risk benefit discussion, right, as most adcoms would go. And so I I think from the benefit side, I I just mentioned a number of areas where we see it’s very clear that Filspari has that strong proteinuria reduction and ties very nicely to Parasol. And on the safety side of things, we have a drug that’s been approved in IgA nephropathy. And I think it’s a very well defined safety profile that’s been comparable to irbesartan that has been available for many years in multiple indications. So there, I think we’ve got a very clear picture.

And I feel like we will be very well prepared and have a good narrative for the AdCom.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Great. And then can you talk a little bit about the size of the FSGS market? Well, obviously, the Street is very excited about it, see it as a really big part of the expansion of Vilspari. But just from maybe a patient number standpoint, give us an idea. Sure.

We’re certainly excited about

Chris Klein, Chief Financial Officer, Trevere Therapeutics: it as well. When we think about the FSGS market, it has the potential to be larger than IgA nephropathy. And from a patient numbers, it’s a little bit smaller. It’s actually about half of IgA nephropathy if you don’t account secondary FSGS. And the main differences that drive our belief in having a strong uptake and strong utilization would be multifold in that you have a differing sort of ambition or awareness of needing to treat the disease amongst nephrologists.

So in IgA nephropathy, it’s taken some time to educate the importance of treating earlier and getting patients below zero point five or 0.3 of proteinuria. In FSGS nephrologists know, right? So they’re motivated. Patients are also very motivated and they’re actively seeking information and understanding of treatments coming through. And so you have a motivated patient and physician group.

You also have a built in experience with Vilspari, right? So there’s a fair amount of overlap between the nephrologists that treat IgA nephropathy patients and FSGS patients. And so we would anticipate that nephrologists will have a very good experience with Vilspari and know quickly to use that in their FSGS patients. And that’s the feedback that we’ve been getting in a lot of our market research. And then we also have it’s double the dose of IgA nephropathy.

Nephropathy. And so between those different dynamics, we believe that it has a very good opportunity for us to be able to help patients.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: And you’re obviously targeting the same physician group as you are now with IGAN. But will anything else need to change with regards to the current commercial structure with if once FSGS if it gets approved? So there is quite

Chris Klein, Chief Financial Officer, Trevere Therapeutics: a bit of overlap. So there’s more than 80% overlap between nephrologists who are seeing IgA nephropathy patients and FSGS patients. But we will be incrementally increasing our sales force, so a small expansion. And two goals there are first to maintain our share of voice in the IgA market. That’s becoming more dynamic.

We want to make sure that we continue to make progress towards our goal of having foundational placement there. But then also we want to make sure we’re getting to some of the pediatric nephrologists because that’s something that we don’t currently focus on in IgA nephropathy with a differentiated label. In FSGS, we studied pediatric patients in the study, and that’s going to be an important component of where we really want to make sure there’s good access.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: What is roughly the overlap in the physicians that treat FSGS and IgAN?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: It’s more than eighty percent.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Great. And then mentioned the peds. So when you’re looking at the sales force, are you able to use the same existing sales force to then start looking at the pediatric nephrologists? Or does that really require a different instrument from a sales standpoint to target the beads?

Chris Klein, Chief Financial Officer, Trevere Therapeutics: We’ll be bringing in again, with a small expansion, we’ll be bringing in similar types of sales reps. So it doesn’t require necessarily a specialty sales rep or a different type of phenotype. I think it’s really going to be focused on rare disease and nephrology. And those are the areas that we have a very experienced sales force currently, and we’ll be able to complement that very well.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Great. And for the time we have left or less time, could you maybe just touch on pegtobatinib and what Sure. The status is for that for

Chris Klein, Chief Financial Officer, Trevere Therapeutics: So pegtobatinib, again, our Phase III or our enzyme replacement therapy in Phase III for HCU. We’re making great progress on our optimization efforts for CMC and our expectation is that we will be able to enroll that study starting next year. And it’s a very exciting opportunity where you’ve got 7,000 10,000 patients in The US and similar numbers abroad that currently have no disease modifying therapies available. And so we’re looking forward to hopefully replicating our phase onetwo results that were very promising for being able to reduce total homocystinuria levels or total homocysteine levels, and we’re excited to share more on that later this year.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity: Well, it’s definitely going to be an exciting time over the next few months from a regulatory standpoint for for both IGAN and FSGS. So we stay tuned and are very excited, and thank you again for for joining us.

Chris Klein, Chief Financial Officer, Trevere Therapeutics: Very good. Thank you for having me.

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