Ep. 348 - Biotech's 2026 Catalysts. Plus: China's New Orphan Rules

RNAi and exon-skipping therapies headline the list of regulatory and pivotal data catalysts in 2026, while new lipid-lowering mechanisms, modalities, and precision medicines define cardiovascular disease catalysts this year. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the most important milestones of the year in new modalities, CV and renal diseases.
The analysts also discuss a new regulation in China introducing orphan drug exclusivity that could incentivize development of rare disease therapies.

Dig into the BioCentury’s catalyst picks and the new China policy below
• 2026 Catalysts: The rise of RNAi
• 2026 Cardiovascular Catalysts: Lp(a) on the Horizon
• 2026 Obesity Catalysts: Launches, readouts and challengers
• 2026 Catalysts: Breakthrough progress in renal disease
• AZ signals all-in on obesity via CSPC deal for $1.2B up front
• China’s orphan drug exclusivity could bolster market, incentivize development

View full story: https://www.biocentury.com/article/658286

00:00 - Introduction
02:28 - RNAi and Antisense Therapies
06:37 - Neuromuscular and Musculoskeletal
10:33 - Renal Disease Catalysts
22:26 - China's New Orphan Rules

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

Transcript

0:00

[AI-generated transcript.]

Jeff Cranmer: 0:01

RNAi and exon skipping therapies headline the list of regulatory and pivotal data Catalysts in 2026. Meanwhile, new lipid lowering mechanisms, modalities and precision medicines will define the year in cardiovascular disease. Part two of our discussion of the catalyst that will drive biotech this year is on the plate for this week's BioCentury This week podcast. And we'll also discuss a new regulation in China, introducing orphan drug exclusivity, A move that could bolster the market for rare disease drugs, and incentivize their development. I'm Jeff Cranmer, host of the BioCentury this week podcast, and joining me today are my colleagues.

Simone Fishburn: 0:59

Simone Fishburn, Editor in Chief.

Selina Koch: 1:01

Selina Koch, Executive Editor.

Lauren Martz: 1:03

Lauren Martz, Executive Director of Biopharma Intelligence.

Steve Usdin: 1:07

And Steve Usdin, Washington Editor.

Jeff Cranmer: 1:09

All right. We'll be jumping into the second part of our discussion of the key catalysts in the biotech sector in just a moment. Of course, you'll remember. Uh, or if you didn't remember, and you are interested in neuro catalyst checkout last week's podcast, Selina's gave us a little, preview of, uh, her, her deck and, story that she, uh, cooked up for us. But first, Bio€quity Europe it's coming up in May. This year's theme, the Need for Speed, how Europe can compete in the New Era. It's the first time we're taking our longstanding conference. This will be the 26th year to Prague. Advanced pricing is in effect through April two, and that's no joke. Limited presenting company presentation presentation slots and sponsorship opportunities remain. Don't wait. This meeting always sells out. if you're interested in being a presenting company, reach out to me directly. And, our sponsorship team, can be reached at conferences @BioCentury.com, and you can go to Bio€quityEurope.com. Alright. RNAi, Lauren, great deep dive here. Where do you wanna start?

Lauren Martz: 2:34

Thanks Jeff. when we're talking about the RNAi catalyst, RNAi and Antisense catalyst for 2026. I think the big one that we're hearing a lot about sort of covers that new modality theme and it also covers the cardiovascular disease theme that, is the highlight of another one of the stories that, that we ran last week. And that is the first Phase III data for an Lp(a) program. this half. We expect to see Phase III data from the Horizon study of Pelacarsen. And this is from Ionis and Novartis. And this is a cardiovascular outcomes trial. So this will be the first time that the hypothesis is tested, the hypothesis of whether reducing Lp(a) actually translates to cardiovascular benefits for the patients who have high levels of this target. So that's about 30%, up to 30% of cardiovascular disease patients. So it could possibly be a, a pretty important contributor to, you know, residual risk in patients who are treated with other mechanisms. I think this is a big deal for the RNA field and the cardiovascular disease field just because, well first of all, it's a big deal for the target because it's a very popular development area right now. This is one of four programs in Phase III testing across different modalities against this target. It's the only one to read out this year. And it's from Phase II data the levels of Lp(a) reduction achieved for this program are slightly lower than the other three programs. So if this is successful efficacy-wise, that's a good indicator for the other programs. We've also heard from companies in the earlier stages of development that that how this study turns out might determine whether they go forward with a compound that they already have more advanced in preclinical development versus, trying to come up with something that can reduce Lp(a) levels even further. Yeah, I think it's potentially another example, of an RNA or antisense therapy in this cardiometabolic space that could become a a clinical success is kind of making this modality more established. We've recently seen the PCSK9. field move forward too. We'll see what happens.

Selina Koch: 4:51

So on the Lp(a), I think it's also, I see it as, it's gonna be an important benchmark. The extent of Lp(a) reduction they see relative to how much clinical benefit they see. Everybody will learn from that. But I think the other interesting parameter there is just durability, right? I think these next ones coming down the line are longer acting perhaps.

Simone Fishburn: 5:12

And would you say that that's really gonna be. what makes 'em take off versus small molecules or something like that? The ability of RNAi to just produce, what, what are they shooting for Lauren? Once a year, like twice a year at the moment moment. I think ultimately, you know, Vas Narasimhan from Novartis has talked about trying to get very long acting products out there. So How much of this is dependent on their ability to be really long lasting as a modality?

Lauren Martz: 5:41

I think that's incredibly important for all of these RNA targeting RNA based therapies. That's the benefit that we're hoping to see. That's the difference from taking, you know, your statin. Every day. But within the Lp(a) space, this is a precision medicine opportunity. These are, you know, this will be for a, potentially a targeted group of patients. And, as I mentioned at the beginning, there's, there are multiple different modalities in the advanced stages of development for reducing Lp(a) so. I think how successful each one is will depend on the durability, will depend on, you know, as Selina mentioned, how much the risk comes down with it, with its ability to reduce levels of, of Lp(a), so

Selina Koch: 6:23

But it's

Lauren Martz: 6:24

be

Selina Koch: 6:24

Great to see a genetic, a genetic target advancing. And even though it's precision and it's great that it's precision and that's gonna increase its chances of success, it's also large. Right? So it's one of those windows of opportunity. Um, yeah.

Simone Fishburn: 6:36

about outside of cardiovascular or cardiometabolic? Because you've also been looking at the neuromuscular space, right. Talk a little bit about that and the importance of RAI there and the catalysts.

Lauren Martz: 6:48

Sure, so with the catalyst that we found and that we chose to focus on, we found 10 Phase III trials across different indications that are expected to read out for antisense or siRNA therapies this year, which is a lot. And I think what was interesting for me was the fact that this was, it spans so many different indications. You've got a Phase III trial from Roche for IgA nephropathy, Angelman syndrome is in there. And then as you mentioned, um, a bunch of the siRNA, Phase III readouts are for musculo skeletal diseases. There are also a bunch of exon skipping antisense in there too. I think that those, there's been a lot of activity in DMD, for example. Um, we, you know, ev everyone's following the gene therapy approval. there's, the potential for a second gene therapy, to maybe reach the market this year, from Regenxbio. And, just given anyone who's been following the story of the gene therapies, in this indication, I think having a second option is a really big deal for patients. There are also next generation versions of the exon skipping therapies that will, have late stage data this year. You know, the Exon 53 and Exon 51, I think there's an Exon 54, which doesn't have any approved therapies. With a big step change in the level of exon skipping and the level of dystrophin expression that's, achieved with those. So that could be really important for patients. And then there are multiple late stage milestones in musculoskeletal diseases that don't have approved therapies, Myotonic Dystrophy Type 1 could see Phase III data this year. And FSHD could also have Phase III data. Which I, I think is very exciting.

Selina Koch: 8:37

Let's take it from the company perspective. Um, maybe, some of the leaders in this particular technology, I mean, obviously Ionis has been in antisense forever as a pioneer, but it seems like it's gonna be a big year and especially big year for them. They have four, I think, readouts in pivotal ones in your, in your analysis deck. They have some regulatory things happening, but, who else should we keep an eye on?

Lauren Martz: 9:00

Sure. So, uh, from. When we're talking about Big Pharmas, there are quite a few from Novartis. So Novartis has some programs that are collaborations with Ionis. We mentioned pelacarsen, the Myotonic dystrophy and FSHD programs that will have Phase III readouts are coming from Novartis. Um, Novartis, uh, is also acquiring Avidity, which should have some Phase III data this year. We have companies like Arrowhead and Wave, uh, that are very active in the late stage catalyst as well. Biogen has, some spinal muscular atrophy, data expected, and some data for an anti tau. So there are a lot of players that are listed in our story about this topic.

Steve Usdin: 9:47

Well, Lauren, I guess there's another company you gotta mention too, right? Alnylam.

Lauren Martz: 9:50

Of course. Yeah. So Alnylam, um, features a lot in our proof of concepts catalysts analysis. they have a bleeding disorder program that should have Phase I and Phase II data this year. There's an RNAi therapy for Huntington's Disease. That's, um, a partnership between Alnylam and Regeneron. So the, um, definitely another player to watch in this space.

Jeff Cranmer: 10:13

Alright. Yeah, you can't, you can't, uh, not mention Alnylam when it comes to talking about, key catalysts the way that company has been rolling over the past couple of decades. Lauren Renal also factored into the three stories you wrote for this five part package of catalysts. what was the most compelling thing you found in that space?

Lauren Martz: 10:37

So there were two take homes from the analysis of the renal disease catalyst, and this was a smaller set, but I think it's just a really important space right now. So the first is that the progress that we've seen in IgA nephropathy is going to continue. There's a ton of activity that's still coming up through the pipeline for this indication that's seen five drugs approved in the past five years. And the other take home message is that other indications within this renal disease space. I think are starting to kind of benefit from the, the clinical development and regulatory path that's been created for IgA nephropathy. So there are at least three renal diseases that don't have therapy specifically approved to treat them, that will either have late stage data or, regulatory submissions this year. What's been happening in IgA nephropathy is the first approval was in 2021, based on a surrogate

Jeff Cranmer: 11:37

First ever. I mean, that's, that's one of the things you really highlighted, right? It was like five years ago there was nothing for that.

Lauren Martz: 11:44

Absolutely. And this was based on reduction in proteinuria as a surrogate endpoint. And you know, that data, the fact that it was able to be used then, it's been used for these subsequent approvals and you know, all the whole body of evidence supporting that surrogate endpoint. Is what's made that an attractive development, path for a lot of companies. So we continue to see additional programs and additional mechanisms move through the pipeline for this indication, We have six, potential catalysts based on our list. Two of them are BLA submissions, three of them are Phase III data. So.

Selina Koch: 12:22

Beyond that, what really struck me, Lauren, is you have the full pipeline in there. I think there's like 15 development programs that you highlighted, even if some of them don't have catalysts this year. Just goes to show you what happens when you have a well worked out regulatory path like that. Yeah.

Lauren Martz: 12:38

and in some cases these are, um, therapies that are approved for other indications so we can, you know, take it forward in this, what used to be an untreatable disease. Based on that pathway. And then my second point was these other renal diseases that are having potentially important readouts this year. So there's APOL1-mediated kidney disease. We are highlighting two catalysts. One of them is an interim Phase II/III readout. We've also got proof of concept data that's, um, from Vertex and Maze Therapeutics. FSGS, there is a PDUFA date for FILSPARI from Travere, which is already approved for IgA nephropathy, And that's one where, you know, it missed the,

Jeff Cranmer: 13:22

April 13th, I think.

Lauren Martz: 13:22

Yeah, so it, it missed the traditional endpoint that you would wanna see to get approval on that indication, but it did have a benefit on, um, the proteinuria levels. So, that'll be really interesting to see what happens there. And then the other indication was membranous nephropathy, which is, an inflammatory autoimmune type disease where, Roche has its anti with a potential sNDA submission this year and some Phase III data.

Jeff Cranmer: 13:50

It's a, it's a really great table you put together for this story as, uh, you can quickly see what the mechanism is, product, catalyst, timing. Great piece here, Lauren. we also had our colleague, Stephen Hansen, added again with obesity, a space that he watches quite closely. Uh, heading into 2026, Steven says The obesity race is widening. There, I said it. Some recent readouts, have been teeing up new mechanisms, new players that could challenge the standard, that's GLP-1 of course, on efficacy or convenience. the biggest obesity catalyst, he is watching, it's already underway at this point. The launch of the oral GLP-1 receptor agonist. Novo is already out there Lily is gonna follow. So if you're interested in the obesity space, definitely check out Stephen's story, it like most of these other stories, comes with a very handy slide deck that you can kind of cruise right through and, and zero zero in on what's most interesting for you. You can download it and the like,

Selina Koch: 15:05

And when you go there, you'll see we have catalyst, at different phases of the development spectrum, right? We have, um, regulatory catalyst, we have Phase III catalyst, but we also are really keen to look at proof of concept for new targets, new technologies, lots of proof of concept in there, and you'll find in the obesity one, there are some that follow the same theme of RNA therapies. So some of the newer targets like INHBE a genetic target, ALK7 a genetic target. There you have Alnylam, you have Wave Life sciences, um, with knockdown approaches, and others.

Jeff Cranmer: 15:39

a lot of interesting stuff happening. And, uh, well, Stephen does talk quite a bit about, the titans in the space. I, I, I'm trying to remind Stephen not to use titan so often, but you know, it's rarely appropriate. But in this case, Novo and Lily, uh, are some serious market leaders, but AstraZeneca had a very busy week last week. One thing it did was it, it kind of signaled that it is gonna go all in on obesity via yet another China deal for the company.$1.2 billion upfront, partnering with CSPC, one of the bigger players in China. The biobucks are, uh, they're bio Bucky, 18.5 billion. And what Stephen wrote was that, this is really showing that AstraZeneca is planning on joining Pfizer and Roche, in making an all in bet to compete with Lily and Novo. Big week for AstraZeneca. A big week for the U.K. and China. Simone. Uh, tear in the eye for your motherland?

Simone Fishburn: 16:45

Tear in the eye? I don't think so. Um, wouldn't, yeah, gotta think about that one, Jeff. Um, I, I think that it's, just, to be honest, I think this is part of a broader geopolitical picture where the U.K. is cozying up to China. Hedging, given that it's very unsure of where it is with the U.S. You know, we know from AstraZeneca's point of view, AstraZeneca has been, I think for a while now, the most heavily invested pharma in, or western pharma, I should say, in China. They've had a very big footprint, notwithstanding some of the setbacks they've had. I, I just see this as, as part of a, picture that is definitely led by AstraZeneca, not exclusive to them. A lot of pharmas. I know, Steve, you've got some thoughts on this that we'll tap into, but I think that, You know, China is a very real alternative, to the US and to Europe at the moment. Cause these are R&D moves that they're building there.

Steve Usdin: 17:49

one, one thing that was really remarkable though is that the press release that AstraZeneca put out about their $15 billion investment in China included a paragraph of quotes from Keir Starmer, the U.K. Prime Minister, hailing AstraZeneca's investments in China. And if you stop and think about it a moment, it's really difficult to imagine that scenario in the United States, for example, or, or anywhere else. Can you imagine a US company investing$15 billion in China and US president coming out and saying, well, that's great. It's showing America America's leadership. so it's, uh,

Jeff Cranmer: 18:26

uh,

Steve Usdin: 18:26

you know, it was quite remarkable.

Simone Fishburn: 18:27

one bit of context that I wanna add, which is, um, so the U.K. has made biotech and biopharma biopharma one of its pillars of growth. Okay? It's one of its major pillars of growth. We know that China did a similar thing, what is it, 15 years ago, whenever they basically set out a strategy to grow their biopharma ecosystem, and this is something that was never strategically done in the U.S. It's sort of, is that fair to say that Steve? I know that there were, you know, tax incentives in, say, Massachusetts and places like that. But I don't know that there was ever a top down, strategy. But what I'm trying to say is that I think that this move in the statement by Starmer is consistent with both the bigger geopolitical thing and the idea that the country wants to, reinforce its own life sciences, footprint.

Steve Usdin: 19:18

Well, you know, I, I think actually if you look at what's happened in what happened in the United States, what really created the biotech industry in the United States. Was a very happy confluence of public policy and science and economic opportunity. But it was, it was based, the foundation of it was good public policy in the United States, starting from massive investment in basic science support for, for IP, a world-class independent regulatory environment, and an immigration system that welcomed the best and the brightest from around the world. All of those things came together and made the biotech industry possible. And made the United States for a time, and maybe, um, maybe that time has passed, but for a time for and made the United States the absolute best place in the world to discover and develop drugs.

Jeff Cranmer: 20:12

Speaking of Starmer and, uh, immigration, Simone, uh, is there any truth to the rumor that, uh, Starmer is in negotiations with Spain for Carlos Alcaraz?

Simone Fishburn: 20:29

Now that that would be a, a rumor worth reporting. I, I definitely think, but you know what, Jeff? Um, there's really only one way to do this, and you just start a rumor and, uh, maybe it comes true, which is what I think you just did there actually.

Jeff Cranmer: 20:42

I think I did. And, uh, you know, it's no secret that, Djokovich is the, uh, the villain of the BioCentury This Week podcast. So, extra kudos, to Alcaraz.

Simone Fishburn: 20:54

I just wanna say Stephen Hansen, very lucky that he's not here. Very lucky he's still got his job because he texted me at the wrong moment causing Sinner to not convert two break points and end up losing. And so that was a very dangerous part of the weekend

Jeff Cranmer: 21:10

It, it was, um,

Simone Fishburn: 21:12

But we'll move on. Stephen Hansen has many other

Jeff Cranmer: 21:14

I'm bracing to give him his performance review. Um, after, after that episode. Alright, we're gonna take a quick break, and we will be back to talk China. What else?

Alanna Farro: 21:26

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Jeff Cranmer: 22:14

Okay. We are back on the BioCentury This Week podcast. Check out our catalyst package, it's awesome What more could I say about it? Go read all five stories. Four decks. And let's turn now to China where Steve is extending biotech's long history of digging into the regulations that have unlocked biotech innovation in China, which shows no signs of letting up. Last week we talked about the new rules, that will accelerate the country's cell gene therapy sector. And today, uh, Steve, let's talk about your, the second story you wrote last week. New law taking effect May 15th, which for the first time is going to grant orphan drugs, seven years of market exclusivity, plus two more years of exclusivity for pediatric indications. What did you learn, Steve?

Steve Usdin: 23:10

I think it's, it, it is really interesting to see, you know, this is another example I think. of China. Looking at what were the, the pillars I just mentioned before, the kind of the pillars that of public policy that made, the biotech industry flourish in United States and and in other countries. And orphan drug exclusivity was certainly one of them. I have to say though, there's a great deal of uncertainty still, even though these laws are gonna go in, this law's gonna go into effect May 15th, about how it's gonna work, and one of the elements of uncertainty is something that you just mentioned, okay. So there's seven years of orphan exclusivity. There's two years of pediatric exclusivity, what isn't known yet, but will be I think before May 15 known. Is whether that two years is gonna be tacked onto the end of the seven years for an orphan, drug that is relevant for a pediatric indication or whether that two years will be included in the seven years. So we don't know if it's seven plus two, if it's nine for an orphan drug, for a pediatric indication, or if it's just seven for an orphan indication, period regardless of whether it's for, pediatric or not. So I spoke with, CANbridge, CEO, James Xue, a former Genzyme executive. And he told me that there are other. Important unanswered questions about, um, the orphan exclusivity. Starting with the definition of rare disease. China doesn't have one. It has two catalogs, listing 207 rare diseases, but obviously that's only a small portion, right? There's over 10,000 rare diseases. It also, as I said, there's also this uncertainty about how the, um, two year pediatric exclusivity, will work. But overall, you know, what he said is that up until now for Orphan drugs, both for, um, orphan drug development and especially as in terms of sales of orphan drugs, China has really been an afterthought. His hope is that orphan drug exclusivity will make China a viable market for orphan drugs, both for developing them and, um, as a market for selling orphan drugs into China. I think there's still a lot of things, a lot of uncertainty that has to happen in order to make that happen. My personal view is that the orphan drug exclusivity, the impact of that. Has been exaggerated in the United States. It was important. But the thing that really created the orphan drug industry in the United States was Henry Tamir, the CEO of Genzyme, figuring out that you could charge a great deal for orphan drugs. And if you had orphan drugs that were really solving unmet medical needs, governments and other payers would pay very, very high prices for orphan drugs. And that created tremendous market incentive. It was bolstered by the seven years of exclusivity because, um, some of the orphan drugs had ambiguous or, or lacking, uh, were lacking in patent protection. But the key to it, is the reimbursement, the reimbursement market in China, reimbursement environment in China, I should say, is quite complex. But there is reimbursement for orphan drugs, especially for orphan drugs. Uh, and it makes it, you know, viable. What, um, what the CEO of CANbridge said to me is that it really makes it viable to develop and to sell orphan drugs in China for markets that are in what, you know, what he called the, kind of the medium range of rare, medium, rare, 10,000 and above. I think it'll be very interesting to watch. One, how this law actually is implemented in practice. And two, what its impact is both in terms of creating a market for in-licensing drugs, um, to China and also for China becoming a springboard for developing orphan drugs for the world market.

Selina Koch: 26:58

I think that's really interesting, the implications. So if it takes off and it supports development of orphan disease therapies in China, 'cause there's now, um, you know, more exclusivity, a better market. Presumably the clinical trial infrastructure would mature there for rare diseases, cause when I, you know, like we just, some of us went to JP Morgan recently and we were running around talking dialogues of companies and one of the things I asked everybody I met was, well, who was heading into Phase I, I'm like, where are you doing your Phase I trials? And when it came to rare diseases and a lot of rare, rare neurological ones, nobody had China on their map. Even though China's becoming a destination for clinical trials for all kinds of things, including early stage trials. And so I wonder if it will trickle down to

Steve Usdin: 27:41

Yeah, that's, that that's gonna be really interesting to watch. I, I don't, I don't think anybody knows the answer to that yet.

Jeff Cranmer: 27:47

Where are they doing their trial?

Selina Koch: 27:49

Early stage trials where people doing them?

Jeff Cranmer: 27:51

Yeah.

Selina Koch: 27:52

Well, it depends on your modality. Like for some, some companies with genetic medicines, they don't find the US is, um, especially accommodating, some of the requirements, here are a little burdensome sometimes what FDA requires for safety margins. It seems like it's still focused on what you would do for small molecules, say, so people are going to Europe, they're going to Australia. Of course, Australia's been a destination. They're going to Canada. And increasingly what I thought was really interesting is how many people said that they were at least considering a U.K, earlier U.K. first, 'cause MHRI has been very accommodating of late.

Jeff Cranmer: 28:29

Interesting. And, and I'm hearing more and more that the U.K. is interested in becoming a, a magnet for that. Simone, didn't you, uh, look into something on that front? U.K. speeding up the dials.

Simone Fishburn: 28:41

So, uh, Lawrence Tallon, who is the CEO MHRA, he, oh, I forget what month it was, but he joined last year. He took the role last year and I mean, the first thing they really wanted to do is stop the decline. Their time from, like the clinical startup time for first inhuman was very, very long. It had slipped from like 150 days to 250. So I think the first thing that they wanted to do was, return to like par with the U.S. or something like 150 days, but now they've gotten more ambitious and like Selina. I'm also hearing, more and more things coming out of the U.K. in terms of incentives and pathways for speeding entry to the clinic and reducing the burden, and we will be talking to them soon.

Steve Usdin: 29:31

and I've also with Lawrence Tallon about that, and they've got a, you know, kind of an integrated plan for taking advantage of some of the competitive advantages that the U.K. has. Excellent genomic data, genomic data that, you know, coverage in, uh, that, doesn't exist in in other countries. An ability, at least in theory to link incentives for development of orphan drugs, especially for ultra orphan diseases, to an HDA and to, to payment and reimbursement. And I think that they do, they definitely have the ambition to become a, a kind of, a launch pad for orphan drugs and especially for ultra orphan drugs. With the idea that it'll be easier and quicker to develop them in the U.K. And then, to use the kind of imprimatur of the MHRA to gain, rapid approvals globally.

Jeff Cranmer: 30:20

Alright, thanks for that, Steve. Thank you for tuning into the BioCentury This Week podcast. Like us, subscribe to us. Uh, let us know what you think. We'd love to hear from you. Uh, we appreciate our listeners and Lauren, Selina glad to see you both still on your feet after that massive catalyst package. Steve Simone, hope you continue to, navigate the glorious weather that you're having in the Washington area. I know Lauren's really enjoying making snowmen, in her yard over and over. Alright, we'll catch you next week. Special thanks to Kendall Square Orchestra for providing the music for BioCentury's podcasts.