Ep. 356 - Arrowhead’s arc. Plus: AI in biotech venture, Synnovation, MFN

After 20 years of platform building and resets, Arrowhead Pharmaceuticals is making a bid to become a large-cap biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the company has built a pipeline and set of enabling technologies that could enable a steep period of value creation based on RNAi.
The team then analyzes the $2 billion deal between Synnovation and Novartis for a pan-mutant-selective PI3Kα inhibitor. The analysts also assess where AI is integrating into the biotech venture funnel and provide insights into ultra-rare disease advocacy, FDA’s search for a successor to CBER Director Vinay Prasad, and the Trump administration’s most-favored nation (MFN) drug pricing policy.

View full story: https://www.biocentury.com/article/658892

#RNAiTherapeutics #BiotechMA #PI3KAlpha #AIDrugDiscovery #DrugPricingPolicy

00:00 - Introduction
01:14 - Bio€quity Europe
05:33 - Arrowhead
16:49 - Synnovation Novartis
20:00 - AI in Biotech Venture
27:07 - Rare Disease Advocacy
31:22 - MFN Pricing Policy

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

After 20 years of platform building and resets, Arrowhead is making a bid to become a large cap biotech. And Synnovation shareholders are reaping a windfall from a$2 billion deal with Novartis. We'll discuss both topics on the BioCentury This Week podcast. Plus we take a look at where AI is integrating into the biotech venture funnel. And bring you the latest on MFN and the search for a new CBER director at FDA. I'm Jeff Cranmer, host of the BioCentury This Week podcast, and joining me today are my colleagues.

Simone Fishburn: 0:46

Simone Fishburn, Editor in Chief.

Stephen Hansen: 0:48

Stephen Hansen, Director of Biopharma Intelligence.

Lindsay Martin: 0:51

Lindsey Martin Biopharma Analyst.

Steve Usdin: 0:54

and Steve Usdin, Washington Editor.

Jeff Cranmer: 0:57

All right, Lindsay. Welcome to the pod. It's good to have you making your debut.

Lindsay Martin: 1:02

Thanks, Jeff. Excited to be here.

Jeff Cranmer: 1:04

Excellent. Well, we'll get to your bit. Lindsay had a very nice story on AI and venture. We'll talk about that in the second segment. But first, uh, Bio€quity Europe, our longest running conference now in its 26 year. The meeting always sells out, so you'll wanna get a move on. It's coming up in May. And for the first time we're going to Prague, so you'll want to make sure you sign up before prices increase April 1st. Simone, you'll be there. I know you're bringing Steven along.

Simone Fishburn: 1:41

I'm super excited. I do want to say for anybody who's sitting around waiting. Do not sit around and wait. Register now because we do sell out and in particular presenting companies, so what we hear year after year is that companies go, they get a really good range of investors attending. European investors, some US investors, really high quality ones. It's a very, very focused meeting, not a trade show at all. So that is the reason actually we, keep the numbers quite small. And then there's a lot of networking events. So as a presenting company, you get certain benefits, but. In addition to the room where you present, there are networking opportunities and you know, Jeff, it's always on that bus to hear or like that little facial over there or whatever it is that Brian has cooked up. And, uh, we have an extra, extra exciting thing this year in that our colleague Steve Usdin is gonna be there. He is joining us at Bio€quity. I think that's been a little while. And he's gonna be interviewing, uh, Richard Pazdur, I believe. and a very compelling session that's gonna be so many reasons to go, uh, not to, to see DC Steve Usdin in the flesh.

Steve Usdin: 3:00

Well, I don't know about me, but, but Rick Pazdur is gonna have interesting things to say and I think, you know, he's particularly charged up and interested in Central Europe. He's spent a lot of time, helping companies and government in Poland, with their oncology regulatory system. And, he's got a lot of enthusiasm for this. And I think that's the thing that really interests me about this meeting in particular, is this idea of kind of expanding our reach and our knowledge, and helping to make connections in Central Europe because I think that's one of the kind of untapped regions of innovation, of clinical innovation, of research, and that's gonna be really interesting.

Simone Fishburn: 3:37

And a last point, because you said that crucial word clinical, Steve, a big theme of the conference is the speed to the clinic, and we will be doing some data analysis on that in our scene setter, and that's a really hot topic. So that's a thread that's gonna run through, and I am sure you're gonna be talking with Dr. Pazdur about that as well, Steve.

Jeff Cranmer: 3:55

Excellent. Well, uh, what are we looking for for presenting companies, private European companies, we are looking for you, early stage, new to the stage. Investors always love getting to hear the new voices out there, seed, series A, series B, drop me a line. You can find me on LinkedIn. You can find me, at my BioCentury, or go to bioequityeurope.com and you can click on the link there. Uh, we've just wrapped.

Simone Fishburn: 4:29

Jo Josh always, Josh always says that, people who present presenting companies have a much higher hit rate for getting partnering meetings as well. This is a rumor that I hear, but I bet it's true.

Jeff Cranmer: 4:41

That is true. And I'm hearing a lot of rumors about delicious, uh, Czech beer. perhaps, uh, those aren't even rumors. That's just delicious. Um.

Steve Usdin: 4:51

I can, I can confirm. I can confirm.

Jeff Cranmer: 4:53

Excellent. Excellent. Um, well, Stephen, uh, will be right there to confirm with you, uh, as well as looking for his next story. So don't miss out on connecting with all of the BioCentury crew at the meeting. We're we're just back from Korea, and we've talked a lot about Korea lately. I, I just wanted to drop in that, um, we have a deep dive deck, that we release to participants at the meeting, it's available on BioCentury.com, uh, along with a, perspective on the state of Korean biotech by Simone. So look out for those. All right, let's dig into it. Stephen Arrowhead. it's been a long road. Really long. I feel like they've been through, um, several incarnations and here we are. They really feel like they've got some momentum. You did a deep dive. We released it last week. What did you learn?

Stephen Hansen: 5:50

Yeah. Thanks Jeff. no, you're right. And I find that, I think this is one of the stories I do find, aspects of these stories I find I find really interesting is just about the history of these companies and how they evolved to get to where they are. I'll try and keep the history bit to a, to a minimum here, but, just to give you an example, so in in Arrowhead's case, they launched in 2003 and they were a nanotech company. And this meant that they were essentially like an umbrella organization that was funding research at various US universities into all sorts of bits, like really small optical sensors or tiny little batteries that, you know, I don't know, maybe that you would use for like a, a mouse sized EV or something like that. Um, but they were basically, they were doing all this, funding, all this research in really disparate industries and they did it for about four years. Nothing really was making too much progress. But they had, as one of these sort of funding projects, they had brought in some IP from Caltech and it was looking at RNAi. And when the current, Chairman, President and CEO Christopher Anzalone, was asked whether he would join the company in 2007, he took a look at these companies at these subsidiaries and was like, I don't know why you've, why you've built the company this way, but it doesn't make any sense. Um, he was like, but I will come in on one condition if we focus this company on the RNAi stuff and just basically get rid of everything else. And so, they agreed and, and that's kind of where, where they went. Now, it wasn't straight up from there. The platform they had was, didn't really work that great. It was working with naked siRNA and if, if people called, you know, the late 2000, late 2000's, early 2010's, companies were still trying to figure out how do you deliver siRNA, in a way that delivers efficacy and does it in a, in a safe way. And there was still a lot to be worked out there. But it was interesting that this kind of then got them started on the road towards, uh, the company they are now. Now along the way, they acquired some assets from Roche, from Novartis. Again, this was a period where pharma had really no belief in RNAi as a therapeutic modality. Uh, so they, I think for them, you know, he said they, they got them on the cheap. but even, even then, you know, that still wasn't sort of getting Arrowhead to where it needed to be. They had IV delivered siRNAs that still were having potential, you know, were still kind of wrangling with the safety. Dosing wasn't really optimized, so it was kind of still sort of suboptimal from where they wanted to be. And so kind of the big turning point came in 2016 when they actually had a, um, a safety signal pop up in a non-human primate study. They hadn't seen anything in the clinic, they had three programs in the clinic. They hadn't seen any problems there, but it came up in this preclinical study and the company had to make a decision. Do we, spend time, spend money trying to figure out whether this is a real signal or not, or do we try to move on to something that we think could be better? And know, I think it was a tough call to make, but you know, in the end, I think it proved to be the right call. Basically, they scrapped their entire, they were in Phase IIB at the time. They scrapped all their clinical programs and shifted to what they call the TRiM platform, which is a subcutaneously delivered sort of new, more simplified, basically more modern version of siRNA. So they went from being a Phase IIB to being a preclinical company, which obviously investors killed them for. But in the end, I think that proved to be the right one because now the pipeline that they have today is really built entirely around this, this TRiM platform.

Simone Fishburn: 9:27

Stephen, thanks. That's a, a very good context for how they got to where they are. Now we have pegged Arrowhead as a company to watch,

Stephen Hansen: 9:37

Yep.

Simone Fishburn: 9:38

believe it was one of our super 17

Stephen Hansen: 9:40

I believe

Simone Fishburn: 9:40

back in 2023 when we did Back to School, which means we think they're potential tier jumper. Talk about their market cap now, why we think this company is worth watching. And, you know, and, and why investors are getting excited about it.

Stephen Hansen: 9:57

Right. So. So where they've gotten now, their market cap right now is just shy of $8 billion. So they're a good size already. But the reason I think investors are really excited about them is because they are literally in the first quarter of their first commercial launch. Their drug was first approved in November of last year. The drug is Redemplo (plozasiran) it was first approved for a very rare setting, so FCS. Where there's, you know, thought to be maybe a couple thousand patients, um, maybe a little bit more. But the real, I think, exciting thing and the real opportunity here is, so this is a drug that targets APOC3. So it's really, it's targeted at reducing triglycerides. and the big opportunity is in the severe hypertriglyceridemia markets. That is where they're already in Phase III and they have data reading out in the third quarter. And that is not a small market that is potentially 3 million patients. And so while the FCS opportunity is sort of the way into the market, I think what people are really looking at is, can you expand this into a broader and broader patient population, with  triglycerides demia? And that then that really gets, you know, talking about a multi-billion dollar opportunity for this drug. And, there's another drug on the market already for FCS, it's Ionis' Tryngolza which also targets a APOC3. But when you look at the data comparison, at least in FCS population, Arrowhead looks like it has better efficacy, there isn't any platelet reduction sort of issue. They have three month dosing, so quarterly dosing. Versus one month dosing. So on the, on the surface, it looks like they have a pretty positive profile for this drug. And so I would expect to see a pretty good launch here. And then if you can start expanding that out that looks even better.

Simone Fishburn: 11:44

A couple of things there. First of all, people don't know how many takes It took Steven to get the name of the drug.

Stephen Hansen: 11:52

Or I, I think, I think it was just just four.

Simone Fishburn: 11:54

given that he went straight to FCS without calling it Familial Chylomicronemia Syndrome,

Stephen Hansen: 12:00

I, wasn't gonna touch

Simone Fishburn: 12:01

it wasn't gonna even, even do that.

Stephen Hansen: 12:03

I was, that. was, that was good. That was almost my hidradenitis suppurativa

Simone Fishburn: 12:06

talk, uh, yeah, well, you know, helps with the accent, you know, we can say anything. Um, but what I, what I wanted to say is, um, I think it's very interesting, and we're seeing this in a few places now. First of all, obviously you've got this smaller indication with the, with the prospect of a bigger indication. In this case, it's not gonna be first in class. You are speaking to a best in class strategy. I would imagine that there's room in that market for both. And what I wanted to highlight here is that in this field, which is effectively cardiovascular, I mean it's still these, you know, we talk about a lot about other diseases, but cardiovascular is still a massive, you know, a massive killer and it's still huge. There's probably room for both and there's still tremendous innovation, in fact, maybe even renewed innovation going in this place enabled perhaps by, genomics and causal biology. And so it seems to me that arrowhead, despite its long journey is actually riding the crest of the wave of those technology forces coming together. Just its delivery plus the genomics. Is that, is that a fair statement?

Stephen Hansen: 13:16

I think, I think, I think that's right. And um, I mean, you know, they're clearly cardiometabolic is kind of their primary focus I think initially. I think what's really interesting is then what comes after this. So Redemplo is kind of like this first step for them into, the commercial phase, which in and of itself, you know, I mean, if we look at, just take their, you know, competitor Alnylam as a comparison, right? I mean, Alnylam went from being a five to$10 billion company to being a. 40 plus. you know, just a couple months ago they were a $50 billion company and all of that was built on one single TTR franchise. So you had one successful franchise and that got them there. And what you have with siRNA right, is you have lots and lots of opportunities to build these sorts of franchises potentially. And so what I think is really sort of fascinating about Arrowhead is you have Redemplo as that kind of first step, but then they have. A couple other cardio focus programs that are gonna be coming behind that. They have several obesity programs that kind of fit into a similar sort of space there for them targeting INHBE and ALK7. ALK7's interesting because that one is one of their first cases in which they've shown that they can deliver outside of the liver that's targeted adipose tissue, and they showed very good mRNA knocked down in adipose cells in their first Phase I clinical trial earlier this year. and they're planning to do lots more of that. So they're really targeting as one area of their growth future going forward is, can we get siRNA, let's go beyond the liver. So can we go to the adipose cells? Can we go to the brain? Can we go to the lung? Can we go to, uh, muscle? So there's lots of different areas that they think is gonna be potential differentiator for them going forward. And then the other one I wanted to talk about was, so they have a dimer that's now entered the clinic. It targets, uh, PCSK9 and APOC3. And that's as far as I'm aware, it's the first instance of a, what's essentially a bispecific siRNA entering the clinic. And that's also something that, Chris Anzalone said is gonna be a big part of their future pipeline, we will be looking at dimers for other indications. He mentioned that there will probably be several dimers coming in obesity for them because he said the, the two that they have in obesity aren't can be the last. And so I think it'll be really fascinating to see, you know, how they go. About picking which targets to do combinations with, but just to see, you know, what, what sort of efficacy you can get sort of using that kind of construct. So, um.

Simone Fishburn: 15:45

I, I have to give credit to, I guess, the CEO and the management team for this strategy. Really seems to be a very good strategy. You really have to be able to demonstrate executional capabilities so people will have confidence, 'cause what they've got is a mix of new technology, a little bit of target innovation, a very clear strategy from going from one product to the next. And if they can demonstrate executionally that they can deliver on clinical trials and data investors are gonna go along for the ride. And so really, you know, the, I, I don't know all the downsides, but there seems to be a lot of, uh, interesting and well thought out strategy in the company. So the wait might've been worth it for them. You know,

Stephen Hansen: 16:27

I think. that, I think this is one of those blooming success stories where it's been a long winding road, but it looks like they're getting

Simone Fishburn: 16:33

story. We love those. We love those on.

Stephen Hansen: 16:36

That's right, exactly

Jeff Cranmer: 16:37

All right. And uh, they are sitting. Now at, uh, 8 billion in market cap,

Simone Fishburn: 16:42

Not too shabby.

Jeff Cranmer: 16:44

not too shabby. We'll, we'll see where they, get to. Okay maybe quickly, Stephen. Uh, Novartis spent 2 billion to buy an early stage oncology asset from Synnovation, and that's gonna generate a return for the VC-backed company shareholders, of course. meanwhile, the startups team of drug hunters will continue to advance, the company's early stage pipeline. kind of an interesting structure to the deal here. what thoughts do you have?

Stephen Hansen: 17:15

Yeah. No, you're right Jeff. I mean, it's, it's it very much, you know, when we saw this deal very harken back to kind of the, the Nimbus like kind of structure where you have this overhead of drug hunters who look for things and you develop them and then you get to the point to where you can then kind of hive it off for a profit that goes back to your investors. And just think is a very interesting sort of way to, uh, to structure a company. And it looks very much like what Synnovation is doing, doing here. And this is, you know, this is specifically in the PI3 kinase space where, you know, historically there's been lots of issues around side effects for some of the early programs in this class. But, you know, more recently, uh, like last year we saw Lilly buy a molecule from Scorpion, for two and a half billion dollars that is taking a similar approach and that you're looking to, you know, go after the mutant sort of version of a PI3K to try and reduce some of the side effect profiles. So. Um, interesting play here and obviously a great, great deal for Synnovation's investors for sure.

Jeff Cranmer: 18:13

Yeah. So, uh, Third Rock led the company's, I think $102 million series A round in 2024. Third Rock, was joined in the syndicate. by NextTech. Lilly Asia Ventures, Sirona Capital, and Cormorant. And the CEO Yao, uh, is telling us that Synnovation is likely to raise money again. So, uh, another one will be keeping our eye on. All right, let's take a quick break and we will get to a little discussion on AI.

Voice Talent: 18:51

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Jeff Cranmer: 19:58

Okay. Lindsay, you, worked on a story, recently, on AI and venture firms. Uh, why was now the time to write this story for you?

Lindsay Martin: 20:11

That's right, Jeff. Yeah, I think, the sentiment has largely shifted so that firms now are really trusting and adopting the use of AI into their workflows. So a year and a half ago, the trust was not really there. And now AI is being used across the entire venture funnel. And so now we're looking at, you know, where is it being used and what are the use cases that are really most important for biotech venture.

Simone Fishburn: 20:38

I mean, I think that's right. I think that globally actually, adoption of AI has gone up. Uh, we've obviously been watching it for a while up by a century, so, you know, I'm gonna imagine that for VCs, they're sort of going along with that general drift. And I think it's more, I think people are still a little bit cautious about it, Lindsay, but maybe they know how to manage the risks a little bit better in terms of what are the, um. What are the data that they put in? And you know, I'm just gonna say that we know that AI has really arrived when our colleague Steve Usdin is creating graphics on the fly of, uh, all kinds of interesting things with cartoons.

Steve Usdin: 21:18

So besides the cartoons, so, so here's my question, and I think it's, it is something you alluded to in the story, which is, I, is AI in venture is it leading to companies, to firms making better decisions or different decisions than they would've without it or simply getting to where they would've any way quicker?

Lindsay Martin: 21:34

Right. I think that's a great question, Steve. So it really depends to what extent the firm is integrating the use of AI. So in some cases, firms are using AI to not just accelerate the pace of their work, but to identify missing information and potentially unlock. New, investment opportunities that maybe they wouldn't have otherwise identified. So in that case it could be augmenting the workflow to identify new things, and then other firms have noted that AI doesn't necessarily change investment decisions, it's just accelerating the process.

Simone Fishburn: 22:10

Can, can you walk through a couple of the kind of either the agents or the kinds of things they're doing that feed into, you know, those outputs that you just said.

Lindsay Martin: 22:19

Yeah. So really AI is being used from both the beginning of the funnel. So things like competitive landscaping, market mapping down to the very bottom, after the check has been written and things like portfolio support. So at the beginning, AI is being used for screening of inbound non-confidential pitch decks. So for example, Sofinnova Partners is really the only firm that we spoke with that is using AI to assess and process their inbound non-confidential pitch decks. So they're using it to understand what companies are coming into the funnel, what do those programs look like, and then they can also triage and rank those, programs to help identify what they should prioritize for, future decision making. And then also identify hidden gems and research partners for the potential companies that they're investing in. And a second example can be things like, um, using multi-agent systems to deliberate among simulated experts. So for example. Deerfield Management, we spoke with Mark Michalski and he told us that Deerfield Management has multi-agent systems that can deliberate, say among a pathologist and an oncologist or a market access professional and an epidemiologist to help identify market pricing or what the population looks like for a disease indication. Towards the bottom of the funnel. Um, another example could be identifying discontinued programs for portfolio companies. So we spoke with David Yang at Lux Capital and he told us that that's an example of how they're using AI to help portfolio companies identify programs that have been discontinued by pharmas or biotechs that could potentially be taken up into, development.

Simone Fishburn: 24:23

And let's just plug here. That you don't have to create your own AI because BioCentury's BCIQ database has now just added discontinued products. So you can use that to find them. If you don't wanna go build your own whole AI.

Lindsay Martin: 24:37

That's right. And it was interesting too because in terms of competitive landscaping and market mapping, some of the firms noted that, you know, they are using AI to help with competitive landscaping, and that really is cutting down on the time that those processes take, right? These are massive undertakings that maybe once took 600 hours and now can be cut down to a much more manageable, maybe 60 hours. But one of the limitations that the firms noted that we spoke with is that it really maybe can't get at the in-depth competitive landscaping and may miss some key insights.

Simone Fishburn: 25:18

Look, as we talked about at the beginning of the call with presenting companies at Bio€quity Europe, the work only goes so far. Still meeting people face-to-face is a big part of it. And I just wanna bridge from there to another face-to-face where our colleague, Selina Koch, did a really great in-depth interview with Najat Khan, who's a CEO of Recursion. And very interesting take on how AI is being used in biotechs, in drug development, and strongly encourage you to take a listen to that because it's really not only about how Recursion is thinking about it, but more broadly, what are the issues that are playing out. It's a conversation that we have over time. As we look at AI and you know, in the same way as you said, we're not where we were a year and a half ago for VCs, nor is that true biotechs are also increasing and getting more sophisticated in the way they're adopting it.

Jeff Cranmer: 26:10

Yeah. And that's on our sister podcast, uh, The BioCentury Show. You can, uh, listen to that wherever you, uh, get your podcast. Spotify, Apple, you name it. Uh, Lindsay, any final thoughts?

Lindsay Martin: 26:24

Yeah, I think now is, is really the time. So the pace of AI is rapidly advancing. And interestingly, Deerfield's Michalski told us that, you know, even if AI stopped advancing at this very moment, it would take another 12 to 24 months just to catch up to where we are now in terms of AI to create living representations of our world around us. So I think, you know, the firms that are integrating AI and seizing the moment are really going to be able to utilize that to their advantage.

Jeff Cranmer: 26:57

Excellent. And, uh, Najat told Selina that AI will be judged by the medicines that it makes. So let's see what it makes. Okay, Steve, uh, there was quite the demonstration at FDA, last week by a group of ultra rare disease, advocates, and no doubt, patience. What's the backstory there?

Steve Usdin: 27:23

yeah, there was a, it, they basically, they had a, what they called a mock funeral in front of FDA, it was patients and family members and advocates, 109 of them who were affected by a very rare disease or actually set of diseases called MPS. And, they're immensely frustrated. By the lack of regulatory progress, by regulatory setbacks at FDA. I've been following MPS and the efforts to move therapies from the lab into the clinic and from the clinic into commercial use for years now. The patients thought two years ago that they had a clear path from. Products that are, in hand now, investigational products to approvals. And that path ran through a biomarker heparan sulfate measured in the cerebral spinal fluid. And it's not working out the way that they, believe that it should. They believe that the products that are, some of them that have been, um, that have received setbacks, some of them that are coming up for approval decisions in the very near future are basically their last hope because they can't wait another 10 years. For new therapies, they don't think that anybody's gonna invest in new therapies if FDA's not approving, therapies based on the biomarkers. And their kids are, progressing rapidly and nothing that's being developed has the potential to reverse progression, they only can slow or stop progression. So they're, they're quite desperate and they're, um, they're, they're quite upset and they brought their case to FDA, they also brought their case to Capitol Hill.

Jeff Cranmer: 29:00

Okay. And, um, well, Steve. Um, where are we, with Prasad leaving, finding a replacement for CBER director.

Steve Usdin: 29:09

And this is interesting because they, of course, the, the patient advocates they directed some of their, ire toward, um, Vinay the, current director of CBER. This is really ineresting so when Prasad was picked, when, previous CBER and CDER directors have been picked over the last year, there've been five by the way, CBER directors and five CDER directors over the last year. at FDA, a year and a few months. In all of those cases, there were processes that were handled, in a really opaque manner. It isn't really clear, um, how the decisions were made and how wide the net was cast. It's being done differently now for CBER. I attribute this to, you know, what I've written about, which is the kind of new chain of command, that HHS has set, set up where, Chris Klomp is now the advisor to the counselor to the HHS secretary and seems to be playing an extraordinarily active role in day-to-day decision making at public health agencies. So instead of just kind of picking somebody, FDA has put out a formal solicitation for a new CBER director, they've emphasized in the solicitation that they want somebody who has policy leadership experience who can, testify before Congress, who is capable of cross-agency coordination and of dealing with regulators overseas. There's explicit reference to emerging technologies in the solicitation. and all of that actually I think bodes well. It, it remains to be seen who, who they're gonna pick, but they're certainly going to uncover a lot of really interesting and, um, talented people through the process. Um, the question's gonna be whether somebody who's really qualified and who would be good at doing the job would be willing to work under the constraints that they would experience in the current administration. I should also say that, it's also, uncovered some kind of silliness, um, Martin Shkreli, was on X over the weekend saying he fine. He'd be glad to take the job. So,

Jeff Cranmer: 31:16

Haven't heard that name in a little while Steve.

Steve Usdin: 31:17

Yeah, yeah. yeah. I guess, I guess he wanted to be, um, relevant again.

Jeff Cranmer: 31:22

In addition to the turmoil at FDA and the changeover in leadership, another topic we've been watching quite closely here. Steve has been watching quite closely here is most favored nation the Trump Administration drug pricing policy. Steve, what's the latest?

Steve Usdin: 31:38

So I, I haven't written about this yet, but there's a lot of activity in Washington that's happening behind closed doors on MFN. The Trump administration's pushing really hard for codification of MFN and industries pushing back. So last week, four large pharmas were invited to the White House. They were shown a 90 page MFN bill and they were asked to endorse it. And even though each of those companies have done so-called MFN deals with the Trump administration, they declined. The Trump administration wants MFN attached to a must pass bill. But the opportunities for doing that are really few and far between. There's talk of a reconciliation bill ahead of the midterms. This is gonna be extremely difficult for Republicans to pull off given their slim majority in the House. There's also talk about attaching MFN to other budget legislation, also really difficult. But that doesn't mean the issue's going away. The industry's gearing up to launch legal attacks on CMS' MFN demonstration models. Lawyers who I've spoken with are quite confident that they'll be able to get an injunction. They're just waiting for the right timing from a legal perspective to file a suit. I would add that lawyers are always confident that they're gonna win their cases. We'll see, when the rubber hits the road on this.

Jeff Cranmer: 32:53

Well that said, the Trump administration's, uh, record in defending some of its policy has, uh, not been the best.

Steve Usdin: 33:00

Well, and there, there's, and there's precedent because in the first Trump administration, companies challenged a similar but different MFN rule, and they managed to have it knocked out by the courts. In that case, it was on procedural grounds rather than the more substantive grounds that, um, they would be going after this one.

Jeff Cranmer: 33:17

All right, well, sounds good. Thanks for the update, Steve. And that's it for this week's BioCentury This Week podcast. We will be back next week. And if you like what you're hearing, uh, don't forget to subscribe to this BioCentury podcast. Kendall Square Orchestra provides the music for BioCentury This Week. KSO connects science and technology professionals and other members of the Greater Boston community to collaborate, innovate, and inspire through music, while supporting causes related to healthcare and education.