Ep. 340 - Obesity Data, Kymera & FDA Survey Results

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[AI-generated transcript.]

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<v Jeff Cranmer>Obesity stays hot with top line data for both injectable and oral therapies pushing the boundaries on efficacy.

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<v Jeff Cranmer>Kymera had a readout that hints at a new era for degraders in immunology.

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<v Jeff Cranmer>And we have the results, BioCentury's FDA survey reflects an industry in distress.

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<v Jeff Cranmer>Plus critical funding for U.S. biotechs caught in a congressional stalemate.

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<v Jeff Cranmer>And wowee what a week for Biotech fundraising.

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<v Jeff Cranmer>We'll discuss all of this and more on the latest BioCentury This Week.

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<v Jeff Cranmer>I'm Jeff Cranmer, one of the executive editors here at BioCentury.

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<v Jeff Cranmer>And joining me today on the pod are my colleagues,

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<v Simone Fishburn>Simone Fishburn, Editor in Chief.

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<v Stephen Hansen>Stephen Hansen, Director of Biopharma Intelligence.

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<v Selina Koch>Selina Koch, Executive Editor.

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<v Steve Usdin>And, Steve Usdin, Washington Editor.

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<v Jeff Cranmer>Hey, hey, hey, J.P. Morgan 2026, like it or not, it's around the corner in BioCentury's, JPM Guide is here to help you out.

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<v Jeff Cranmer>Head to jpmguide.com to browse the lineup of sideline events and receptions planned across San Francisco.

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<v Jeff Cranmer>Okay.

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<v Jeff Cranmer>obesity,  it's the story that won't quit this year.

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<v Jeff Cranmer>We had data out of Lilly for the company's triple agonist.

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<v Jeff Cranmer>it showed best in class weight loss.

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<v Jeff Cranmer>Structure, got back into the oral GLP-1 race with some strong Phase IIb data.

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<v Jeff Cranmer>And Pfizer, back in the race and making yet another deal.

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<v Jeff Cranmer>Stephen is following all of this, Stephen.

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<v Stephen Hansen>Yeah thanks, Jeff.

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<v Stephen Hansen>going on, I guess.

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<v Stephen Hansen>Um, but, uh, yeah.

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<v Stephen Hansen>So Lily's, uh,

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<v Jeff Cranmer>We're doing a very racy podcast.

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<v Stephen Hansen>oh, okay.

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<v Stephen Hansen>Uh, so I think we should start with Lily's, uh, Retatrutide, as you said, they're triple agonist, which is a GLP-1, uh, GIP and glucagon, uh, receptor agonist.

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<v Stephen Hansen>Sort, I've always been sort of hyped as being the, one that would probably drive the biggest efficacy.

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<v Stephen Hansen>And, you know, I, I, I don't think it disappointed from, from that respect.

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<v Stephen Hansen>it had already shown, you know, pretty compelling efficacy in Phase II, where it showed about a 22% weight loss at I think it was 40 weeks.

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<v Stephen Hansen>And here this is the first Phase III readout.

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<v Stephen Hansen>And of note, this wasn't just obese patients, these were obese patients with osteoarthritis.

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<v Stephen Hansen>At 68 weeks, there was, as you said, the largest weight loss we've seen thus far, 26.6% placebo adjusted weight loss, in this patient set.

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<v Stephen Hansen>I mean 40% of patients achieved more than 30% weight loss, nearly a quarter 35%.

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<v Stephen Hansen>And the thing that stuck out to me most was the first time that I've seen a company include in their reasons for treatment discontinuation, as being this a perception of excessive weight loss.

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<v Stephen Hansen>That was one I had not, uh, had not come across before.

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<v Stephen Hansen>The thing with this program though, is, it drives so much weight loss that, that it really is probably gonna be limited to sort of the highest BMI sort of patients.

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<v Stephen Hansen>It doesn't mean that that's a small group, but I'm sure there, there's still a very healthy market for that out there.

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<v Stephen Hansen>But this is not probably gonna be as widely used in my opinion as, you know, the Wegovy or the tirzepatide that are out there, which, you know, give anywhere from 15 to 20% weight loss.

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<v Stephen Hansen>This is really for the sort of severe obese population and sort of serving that higher, higher population.

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<v Selina Koch>but Steven, so if you look at the very early data, like the weight loss is pretty quick.

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<v Selina Koch>With this drug candidate compared to others, right?

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<v Selina Koch>So couldn't you just like take it for a while, lose the weight?

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<v Selina Koch>I, I don't know, like why wouldn't you try to go for some big weight loss kind of quickly?

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<v Stephen Hansen>you could.

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<v Stephen Hansen>Um, I, I think first off, we probably wanna spend a bit of time doing some work on how healthy that level of weight loss is for an individual dropping that much that quickly.

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<v Stephen Hansen>I don't think we actually have a good sense of what that is.

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<v Stephen Hansen>And then on top of it, the adverse event profile for Retatrutide, you know, in comparison to the other ones is a bit worse.

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<v Stephen Hansen>I mean, there's more of the nausea, there's more of the vomiting, there's more of that stuff that comes with it.

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<v Simone Fishburn>Steven, can you talk a little bit about the mechanism, because this is a triple agonist, right?

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<v Simone Fishburn>It's GLP-1/GIP/GCG, glucagon receptor, and it doesn't have an amylin component, which is like some of the other ones that you compared it with.

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<v Simone Fishburn>So going back to your and Selina's question, or points rather.

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<v Simone Fishburn>Do we know anything about why this extra, the triple agonism either weighs in to the side effects or to the rapid weight loss or to Selina's point, like at the end of the day, you've really just added, let's say, an extra agonist, what if you switch to another one, it's not really clear to me how much we know mechanistically about this.

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<v Stephen Hansen>So, these three, the, GLP-1, GIP and GCGR, as you said, the glucagon.

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<v Stephen Hansen>So these are your sort of three traditional sort of incretin mechanisms.

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<v Stephen Hansen>There's always been interest in this.

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<v Stephen Hansen>I know that, Novo pursued one for a while, but all have the same sort of issue in that they have this gastrointestinal side effect profile for each of them individually.

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<v Stephen Hansen>And so the problem is as you stack them, you can potentially have additive side effect profiles that add on that just simply make it intolerable.

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<v Stephen Hansen>And that's been a problem for a lot of the previous triple agonists that have been trialed early in clinical trials, is they've just hit thresholds that the companies deemed to be sort of unacceptable from a tolerability perspective.

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<v Stephen Hansen>Now, Lilly obviously seems to think that there's a market, even if they have these high levels of adverse events.

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<v Stephen Hansen>Which they may be right, but I think it, it just, it's not surprising that we're seeing higher levels with this.

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<v Selina Koch>So is that the main reason for the increased discontinuations then?

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<v Selina Koch>At the top you talked about excess weight loss, but.

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<v Stephen Hansen>So yeah, the main reason I think was still the tolerability.

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<v Stephen Hansen>Um, I mean, they did note that in patients with higher BMI's, I think the discontinuation weight rate dropped from 20% for the entire population, but it was down to about 12% at the high dose for like a high BMI population where you kind of cut out that maybe perception of excessive weight loss sort of cohort.

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<v Stephen Hansen>I think it's still, I don't think this is gonna be one where I I wouldn't think that this is gonna run away and sort of dominate the obesity market.

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<v Stephen Hansen>Cause as I said, and I think we've talked about this podcast before, I think we're transitioning to a point to where we're kind of beyond the, the weight loss Olympics where you have to just get a super high amount of weight loss.

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<v Stephen Hansen>And so I think this, this will definitely target  a certain section of the obesity population, but I don't think this is gonna be as widely taken up, you know, by everyone as as some of the other ones have.

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<v Simone Fishburn>So one, one last question because, what you've done very nicely on the chart is sort of color code, the Novo ones, the Lilly ones.

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<v Simone Fishburn>It seems that each one has sort of a obviously a portfolio.

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<v Simone Fishburn>And it is really such a very, very large patient population that don't you feel there's just room for all of these products.

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<v Stephen Hansen>Oh yeah, for sure.

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<v Stephen Hansen>No, I, I think there is, because I mean, the existing ones are, are pulling in, you know, 20 billion, you know, close to that in revenue a year and we've barely hit 1% of the population, you know, in terms of being able to get into it, 1% of the patient population.

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<v Stephen Hansen>So there's, I think there's still a lot of room for other players to come in.

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<v Stephen Hansen>And, you know, with that note, I think that's a good lead into the other big data announcement, which was the Structure data for their oral GLP-1 Aleniglipron, which had kind of fallen I think by the wayside a little bit in terms of like companies that investors were talking a lot about.

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<v Stephen Hansen>Because they'd had some, maybe less than stellar early data, uh, that had people a bit worried.

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<v Stephen Hansen>But they reported Phase IIB data, from a couple trials.

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<v Stephen Hansen>One where they dosed up to 120 milligrams that basically showed about 11% placebo adjusted efficacy, which kind of puts it on par with Lilly's Orforglipron, which is the most advanced oral small molecule GLP-1 agonist.

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<v Stephen Hansen>But then they had a second study that dosed up higher to 240 milligrams, where they showed up to 15% placebo adjusted weight loss, which is really what people were hoping to see from Orforglipron in their Phase III studies.

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<v Stephen Hansen>It looks like they might have a potential advantage of going higher.

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<v Stephen Hansen>The big question though is we don't know what the adverse event profile looks like for that higher dose.

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<v Stephen Hansen>Now structure has been talking about,  titration sort of strategies they can use, starting with a much lower dose and some more slowly titrating patients up to try and sort of you know, optimize that tolerability profile.

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<v Stephen Hansen>that's sort of a key outstanding question here for this.

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<v Stephen Hansen>But, think it brings structure sort of back into the frame with regard to if there's a pharma company out there that wants to get kinda leapfrog back into the oral GLP-1 race structure looks like a pretty attractive candidate right now.

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<v Jeff Cranmer>Yeah, and this is the company, uh, launched by Raymond Stevens, he's, still the CEO.

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<v Jeff Cranmer>He uh sold his prior company Receptos for multi-billion dollars to BMS Celgene, back in the day.

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<v Jeff Cranmer>So certainly one to watch.

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<v Jeff Cranmer>Uh, quickly, Stephen, speaking of doing deals, Pfizer again, after  they did their big deal, now they've kind of tacked one on out of Fosun.

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<v Stephen Hansen>Yeah, so they obviously, everyone, you know, we spent many, many minutes talking about their, uh, deal with Metsera.

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<v Stephen Hansen>That basically got them into the sort of, largely into the injectable sort of peptide, part of the obesity race.

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<v Stephen Hansen>Well, now they've done a deal with Fosun to sort of come back in on, on the small molecule side, so something that would be competitive with the Structure and the lily uh small molecule programs.

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<v Stephen Hansen>We don't really know a lot about the molecule.

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<v Stephen Hansen>We don't think we've seen any data yet.

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<v Stephen Hansen>But obviously, you know, Pfizer has a history here.

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<v Stephen Hansen>They had two prior small molecule GLP-1 programs, that ended up being discontinued either for efficacy or for liver issues.

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<v Stephen Hansen>Um, so I think they're very much hoping that third time is a charm here and they can, uh, you know, be back in this race, which, you know, as Simone already pointed out, I mean, it's such a massive market.

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<v Stephen Hansen>I think there's plenty of room for multiple small molecule programs to be effective here.

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<v Stephen Hansen>Whether they're positioned as frontline therapies or as maintenance therapies.

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<v Stephen Hansen>Once people come off these injectables, I think there's gonna be a lot of opportunity for these GLP-1 small molecules.

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<v Selina Koch>What about wave life sciences?

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<v Stephen Hansen>that was.

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<v Selina Koch>So I mean, okay, you talk about differentiators, right?

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<v Selina Koch>And you're like, okay, well just a little bit more weight loss is no longer a differentiator.

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<v Selina Koch>You want something long acting, you want something oral, or you want muscle sparing.

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<v Stephen Hansen>Wave definitely showed that.

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<v Stephen Hansen>I mean, they have, looks like they have the muscle sparing thing in hand.

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<v Stephen Hansen>So I've spoken to a couple investors that thought maybe that was the, um, so they, they were up pretty big on their early Phase I data to for their INHBE antisense program.

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<v Stephen Hansen>Think there were some investors that thought maybe it was a bit too much excitement from investors on that.

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<v Stephen Hansen>I mean, look, I mean, the way they're looking to position it is something that you can basically transition off of a once weekly injectable onto something that you could take maybe once a yearly.

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<v Stephen Hansen>And if you can maintain that weight loss while potentially either maintaining muscle mass or even maybe, I don't know if you could even start building a little bit of muscles, having muscle come back, seems like a pretty compelling product profile to me, even if you're not getting additional weight loss.

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<v Stephen Hansen>'Cause I think the idea there is that you've already done the weight loss bit and now you just want to keep it off.

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<v Stephen Hansen>Yeah, it's pretty exciting, but as, as you said, it's very, very early data, so we will, we'll see what, we'll see what comes from that.

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<v Jeff Cranmer>All righty.

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<v Jeff Cranmer>Thanks for that, Stephen.

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<v Jeff Cranmer>More data Kymera has taken the next step toward its goal of bringing oral drugs with biologics like activity to autoimmune disease patients.

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<v Jeff Cranmer>the company had a Phase IB readout for its STAT6 degrader in atopic dermatitis.

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<v Jeff Cranmer>The data sent shares up more than 40%.

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<v Jeff Cranmer>Selina, you wrote a little piece on this.

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<v Jeff Cranmer>What'd you find?

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<v Selina Koch>Yeah.

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<v Selina Koch>first I think it's worth noting this is a needed win for Kymera.

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<v Selina Koch>This is a platform company that's now a decade old.

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<v Selina Koch>So at this stage of the game, you need some positive clinical readouts, right.

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<v Selina Koch>Um, it was initially like dual tracking cancer and immunology and then regrouped at some point and said, putting all our chips on immunology.

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<v Selina Koch>It had an IRAK4 program that with Sanofi, Sanofi decided not to take it forward, although that partnership does progress with the backup compound.

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<v Selina Koch>So in that context this was important.

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<v Selina Koch>Kymera is one of the leaders in one of the hottest new therapeutic modalities in the industry, right, targeted protein degradation.

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<v Selina Koch>Often these molecules are just referred to as degraders.

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<v Selina Koch>And one of the promises of degraders is to have a way to get at difficult targets that you know are historically undruggable, because they don't have a good binding pocket for a small molecule inhibitor.

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<v Selina Koch>Or the target's not on the surface, it's not accessible to antibodies, that kind of thing.

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<v Selina Koch>So STAT6 is one of these undruggable targets cause it is a transcription factor, so that puts it in a, a class of notoriously difficult to drug targets.

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<v Selina Koch>It appealed to Kymera who obviously, you know, they have a new technology, so they have some technology risk and they've had some kind of setbacks, right, because it kind of minimizes biology risk while also showcasing the ability to go after an undruggable target.

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<v Selina Koch>So STAT6 sits downstream of the same receptors hit by Dupixent, so that's IL4 and IL3.

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<v Selina Koch>So Dupixent obviously big multi blockbuster biologic for inflammatory conditions.

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<v Selina Koch>So the way Kymera saw this was that, the biology risk would be reasonably low, but there's a massive market opportunity here because these are chronic conditions, right.

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<v Selina Koch>Patients are treated for long periods of time, and many of them would prefer an oral alternative, if you could get that same sort of selectivity and efficacy that you could get with biologic, which has been historically very hard.

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<v Selina Koch>So it's a problem a lot of, a lot of companies want to solve, including a lot of pharmas.

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<v Selina Koch>Although right now this program remains unpartnered, I'll say.

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<v Selina Koch>So yeah, this is, this is still an early stage, still a small trial, but what they did see was 94% degradation of STAT6 in skin reaching 98% in blood, so that's very deep degradation.

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<v Selina Koch>And then importantly, that translated to changes in biomarkers that are key ones commonly used to track therapeutic activity in atopic dermatitis and some other, conditions that involve type 2 inflammation.

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<v Selina Koch>So this could, this therapy could work, you know, much more broadly than just atopic derm.

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<v Selina Koch>Those include the Chemokine(TARC), IL31, Eotaxin-3

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<v Simone Fishburn>Selina, I mean, I think this is really interesting.

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<v Simone Fishburn>As you pointed out, Dupixent is such a blockbuster, and there are a few competitors, most of which I think are biologics, right?

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<v Simone Fishburn>So here you're going in with a small molecule or small molecule modality, but effectively an oral agent.

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<v Simone Fishburn>I'm sort of wondering what the path is gonna be.

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<v Simone Fishburn>Are they gonna go for people who've cycled off Dupixent or do you think they'll, you know, I, you know, Paul Hudson, the CEO of Sanofi has several times talked about the fact that I think, under 10% of atopic dermatitis patients are actually accessing treatment or receiving treatment.

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<v Simone Fishburn>And then even within those, they cycle on and off of these therapies, with the course of the disease.

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<v Simone Fishburn>So I'm sort of wondering how you see this fitting into the landscape or, or if it's, if we're able to talk about that?

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<v Selina Koch>Well, I do believe the com is keeping their options open to some extent.

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<v Selina Koch>So they're running a Phase IIB trial right now, it's ongoing, it's called BROADEN2 for, moderate to severe atopic dermatitis, so not the mildest patients.

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<v Selina Koch>And they are enrolling, you know, I believe patients who are biologic naive and those with prior exposure.

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<v Selina Koch>But, the exclusion criteria, I believe does not allow for patients to enter if they have been non-responders in the past to Dupixent a JAK inhibitor, things like that.

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<v Selina Koch>So that that's where it's, you know, initially this mid-stage, fitting into the landscape.

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<v Simone Fishburn>And like you said, I mean, I think it's a pretty important proof of principle as we start to knock off these  undruggable, but I think now they like to call them hard to drug targets as we knock them off one by one, they no longer become undruggable.

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<v Simone Fishburn>So, you know, getting STAT6 in there, probably open the door to a few other transcription factors.

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<v Simone Fishburn>Wouldn't you think?

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<v Selina Koch>I would think, yeah, that's the hope.

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<v Jeff Cranmer>All right, and if you'd like to learn more about Kymera and its technology, uh, Selina sat down with company Nello Mainolfi, in October on our sister podcast the BioCentury Show.

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<v Jeff Cranmer>And you can find that on Apple, Spotify, YouTube, you name it.

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<v Jeff Cranmer>While you're there, like us, subscribe to us.

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<v Jeff Cranmer>We're wrapping up our sixth season of BioCentury's This Week, and we're very grateful to you, our listeners for supporting us along the way and making us one of the top biotech podcasts out there, couldn't do it without you.

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<v Jeff Cranmer>Okay, Kymera, Structure and Wave, were among eight biotechs raising more than 3.2 billion total between Tuesdays closed last week and Wednesday's morning bell.

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<v Jeff Cranmer>And if that doesn't signal strength in the marketplace for follow-ons in the sector, well, I don't know what would.

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<v Jeff Cranmer>More followed later in the week, bringing the weekly total to nearly 4.5 billion.

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<v Jeff Cranmer>And how did that look compared with the rest of the year, Selina?

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<v Selina Koch>Yeah, we did calculate the weekly totals for follow on financing this year, and it was triple the next biggest week.

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<v Selina Koch>So a big bump to finish the year, uh, strong.

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<v Jeff Cranmer>Yeah.

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<v Jeff Cranmer>The top weeks from earlier, we had two weeks, I think at about 1.4 billion, one it 1.3 billion and the rest were uh, kind of meh as,

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<v Simone Fishburn>Yeah, but I mean, I gotta tell you, if you look at this chart, there's a very clear pattern.

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<v Simone Fishburn>The first half of the year was very, very dismal.

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<v Simone Fishburn>Just a few little spikes there on the weekly amount, but this last quarter has been, as one person can't remember if the words they used were gangbusters or you know, the follow on market being very, very healthy.

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<v Simone Fishburn>And then as you say, this huge spike in the 50th week of the year, according to the chart.

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<v Simone Fishburn>So, uh, the Jubilee or whatever, the Jubilee week.

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<v Simone Fishburn>certainly.

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<v Simone Fishburn>Good to have some good.

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<v Selina Koch>Maybe a little, maybe a little sneak peek because we've also been looking at new venture funds raised this year.

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<v Selina Koch>The, you know, announced ones and the pattern looks very similar.

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<v Selina Koch>You see very few new funds being announced in the first half of the year, and, and it has picked up.

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<v Selina Koch>So that'll come out.

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<v Jeff Cranmer>Yeah, indeed.

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<v Jeff Cranmer>And, our one listener who tells us to talk more about Japan, uh, he will be pleased to know that, uh, think there were more venture funds raised in Japan this year than China or Korea.

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<v Jeff Cranmer>We're still digging into that to confirm.

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<v Simone Fishburn>I just wanna know, is that one listener our colleague Matt Krebs?

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<v Jeff Cranmer>It's not actually, it's not.

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<v Jeff Cranmer>Um, uh, Matt though, Matt is a big, big supporter, of the podcast.

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<v Jeff Cranmer>Just a few numbers.

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<v Jeff Cranmer>Structure raised $650 million, Kymera $ 602 million, Wave at $350.

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<v Jeff Cranmer>The other big, big one came from Turns, at $650 million.

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<v Jeff Cranmer>So, congrats to all those companies.

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<v Jeff Cranmer>It's, certainly great to see and to do it right before JPM.

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<v Jeff Cranmer>Maybe the sun will finally shine in San Francisco during JPM.

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<v Jeff Cranmer>Alright, we're gonna take a quick break and we're gonna turn to Washington.

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<v Jeff Cranmer>Okay.

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<v Jeff Cranmer>And I am  recruiting, presenting companies for the conference.

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<v Jeff Cranmer>If you're interested or you know, a company that I should check out, drop me a line The results of our survey are in here to tell you about it, Simone.

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<v Simone Fishburn>Well, thanks Jeff.

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<v Simone Fishburn>I really wanna pick up from the very positive sentiment that seems to be happening in the capital markets.

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<v Simone Fishburn>I don't think the IPO markets have, uh, picked up yet, but it's really good to see the secondaries or the follow ones as we call them, and venture going well.

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<v Simone Fishburn>And I say that because on the regulatory front and generally there is a very big shadow over biotech, caused by the uncertainty, the volatility, and in particular the politicization of FDA according to the survey that we ran.

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<v Simone Fishburn>And why did I tie it to the markets because really there's still a feeling that it is very hard for investors to engage and to get excited about about biotech.

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<v Simone Fishburn>So obviously we see that's happening to some degree, but I wanna go into some of the issues that came up in our survey.

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<v Simone Fishburn>So I think that there are three principle points.

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<v Simone Fishburn>One of them is, is a fairly positive one, which is that the people who engage with the survey, which are mostly biotechs, about two thirds biotech, uh, and about one third investors, and then there are a few other stakeholders, but they really say that this year, their interactions with FDA have mostly continued with the same kind of efficiency as last year, productive interactions, that's about two thirds of them.

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<v Simone Fishburn>And so I feel that there's very broad support inside the industry for the staff at FDA.

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<v Simone Fishburn>And we've talked about this before, the staff at FDA are working incredibly hard, and that actually is why companies are able to move ahead, generate positive clinical data and raise on the back of that, right.

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<v Simone Fishburn>But it's not clear that past is gonna be prologue.

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<v Simone Fishburn>The second thing that is clear from this survey is there are huge concerns about the leadership.

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<v Simone Fishburn>So the biopharma industry is quite sophisticated and they know how to distinguish between the leadership of FDA and the staff and the operations.

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<v Simone Fishburn>And they have huge concerns over the leadership.

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<v Simone Fishburn>Even the respondents who are quite, there are a few respondents who are quite supportive of FDA Commissioner, Marty Makary.

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<v Simone Fishburn>Although he and the Head of CBER Vinay Prasad caught quite a lot of harsh criticism as well.

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<v Simone Fishburn>But even the people who are supportive of Makary and some of his initiatives really and, every single comment, but one, questioned whether they have the competence to actually execute on what they think might be good initiatives.

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<v Simone Fishburn>So if the first main two findings are that the FDA staff retain broad support from the industry.

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<v Simone Fishburn>And the second being that the leadership has got really overwhelmingly negative ratings.

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<v Simone Fishburn>I think the third part is this uncertainty and the inconsistency being this huge shadow.

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<v Simone Fishburn>The consequences are not only chilling investment, but many people,  who responded as saying they are moving their clinical trials outside of US territories.

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<v Simone Fishburn>And this won't surprise anybody completely abandoning vaccine programs and investment in vaccines.

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<v Selina Koch>Yeah, Simone, along those lines, I thought it was kind of interesting that 20% of respondents say they had personally through their companies, or if it was an investor one of their portfolio companies experienced a reversal of an FDA position or of earlier guidance on trial design, that sort of thing.

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<v Selina Koch>And there's this perception that that's becoming more common.

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<v Simone Fishburn>Right, so.

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<v Simone Fishburn>That's correct.

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<v Simone Fishburn>So about 20%.

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<v Simone Fishburn>As you point out, we did ask people whether they had had, FDA change its guidance to them or its instructions to them, reverse a position that it had taken previous to 2025.

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<v Simone Fishburn>So under the previous leadership, 20% said yes.

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<v Simone Fishburn>We also asked whether there was a perception whether they believe that FDA rehearsals on trial design are becoming more common.

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<v Simone Fishburn>And a large majority, like 85%, think that it's becoming more common.

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<v Simone Fishburn>We don't have the numbers to tell you whether it's becoming more common, but most people believe it is, and most people believe that's a bad thing.

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<v Simone Fishburn>And Steve, I expect you wanna comment in a minute.

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<v Simone Fishburn>Let me just add one more point because I, I'd like you to answer this as well.

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<v Simone Fishburn>We also asked about accelerated approval, most people think that that is going to get harder.

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<v Simone Fishburn>many think that it will be easier in some indications and harder in others, but across the board about,  more than half I think, believe that it's going to get harder in some indications.

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<v Simone Fishburn>So, do you wanna address a couple of those things, Steve?

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<v Steve Usdin>Yeah.

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<v Steve Usdin>Yeah.

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<v Steve Usdin>so, so I think well look, the critical thing to.

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<v Steve Usdin>Point out is that the survey was done when Richard Pazdur was CDER director and nobody knew at that time that he was planning to retire.

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<v Steve Usdin>I think if we were to do the survey again now, results would be more negative, than they were especially about political influence and ideological influence on FDA regulatory decisions.

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<v Steve Usdin>I think the other thing that's really important to point out, it's really interesting.

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<v Steve Usdin>All of us have been out there talking biotech CEOs, to investors, to other stakeholders.

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<v Steve Usdin>And there's exactly two things that everybody wants to talk about.

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<v Steve Usdin>The first is what's happening at FDA, and the second is what's happening in China.

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<v Steve Usdin>And I think that the two things are linked.

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<v Steve Usdin>Right.

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<v Steve Usdin>One of the things that's been a competitive advantage for the United States over the years has been an innovative, science driven regulatory environment.

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<v Steve Usdin>The sense now is that we're losing that, that that's being degraded.

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<v Steve Usdin>And it is happening in conjunction, with a rise in,  China and  biotech ecosystem, which is being facilitated in part by their own innovative, science-driven regulatory environment.

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<v Steve Usdin>You know, it's not a coincidence that, we're seeing, those two things happen in conjunction with each other.

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<v Simone Fishburn>Right.

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<v Simone Fishburn>I just wanna end with, one quote from somebody.

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<v Simone Fishburn>So, as I pointed out, many of the quotes were quite caustic and negative.

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<v Simone Fishburn>Absolutely you are right that there's, some people who were literally wrote in the words.

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<v Simone Fishburn>thank goodness for Pazdur this, this, uh, this survey was conducted while he was still, at the top of CDER.

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<v Simone Fishburn>But here's a quote that I just thought really, really represents across the board what people think.

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<v Simone Fishburn>Even those who agree that FDA could use some fixing.

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<v Simone Fishburn>One person wrote, "Get your act together.

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<v Simone Fishburn>The headlines are terrible.

00:28:32.210 --> 00:28:34.412
<v Simone Fishburn>The infighting is disheartening.

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<v Simone Fishburn>Personnel decisions are awful.

00:28:36.548 --> 00:28:42.787
<v Simone Fishburn>You are seriously jeopardizing your credibility and this industry, right When we are in a race with China.

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<v Simone Fishburn>Get a meeting with the top leadership of FDA along with RFK Jr. and get alignment, then speak with one voice, give clarity, uncertainty is the death nail to this industry." That's from one respondent, as I said.

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<v Simone Fishburn>So I think there's just a feeling that FDA needs to fix itself.

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<v Simone Fishburn>And on that note, I'll, I'll pass it back to you, Jeff.

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<v Selina Koch>I can say for folks out there, who haven't looked at it yet, there is both the quantitative side of the survey and as Simone was just reading the qualitative, um, we did let people speak in their own words and it was anonymous, but we put a bunch of their own words in there as well.

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<v Selina Koch>So that's available our website.

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<v Jeff Cranmer>Go to BioCentury.com.

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<v Jeff Cranmer>BioCenturypodcast.com and you'll be able to find it there, and we'll create a link if you're not a subscriber, that allows you to, to get your hands on this very interesting, uh, somewhat depressing survey.

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<v Jeff Cranmer>All right, apparently I'm told by my colleagues that I'm the only person in the world who calls SBIR Grants siber Grants.

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<v Jeff Cranmer>And well, my mom always told me I was special.

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<v Jeff Cranmer>I guess that's why.

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<v Jeff Cranmer>Um, so, you know, this funding is critical for biotechs and it just happens to be caught up.

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<v Jeff Cranmer>One of the many things caught up in a stalemate in Congress, and Steve took a look at this, um, Steve, what's the word?

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<v Steve Usdin>Yeah, SBIR, the Small Business Innovation Research Program does really a cornerstone of early stage funding biotech startups.

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<v Steve Usdin>Expired on September 30, and cutting off a major source of non-dilutive capital for small life sciences companies.

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<v Steve Usdin>As you said, Congress is deadlocked over its future.

00:30:29.259 --> 00:30:37.434
<v Steve Usdin>Basically there's a disagreement, uh, between parties in Congress who wanted to simply reauthorize it, at least to reauthorize it for a year.

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<v Steve Usdin>Well, there's discussion about, reforms and, well, in basically Senator Joni Ernst, who wants to change the SBIR program in a lot of very significant ways.

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<v Steve Usdin>Many of those ways that the biotech industry, and small businesses and other industries oppose.

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<v Steve Usdin>So the deadlock has not been broken and right now, to be honest, there isn't a clear sight to how that might happen, is really unfortunate.

00:31:07.397 --> 00:31:17.842
<v Steve Usdin>And it's, also interesting because this is one of the very few, government programs I think that has, nearly unanimous bipartisan support, it's been really important.

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<v Steve Usdin>And if we're gonna talk about China, because we always talk about China these days, it seems, it's also another area where there's a contrast because, China learned from the success of the US SBIR program and put in place similar programs, programs that were modeled on SBIR but are much larger scale.

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<v Steve Usdin>And, they've been really important in helping them ramp up.

00:31:40.832 --> 00:31:41.199
<v Selina Koch>Yeah.

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<v Selina Koch>I mean, if we stop funding these ideas, early stage ideas, through that so-called Valley of Death, we do risk falling behind in an area where we were leading.

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<v Simone Fishburn>You know, I think most people who've started a company have at some point entertained the idea of having an SBIR, if not actively sought one.

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<v Simone Fishburn>So I think we all acknowledge how important they are for the industry.

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<v Jeff Cranmer>All right.

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<v Jeff Cranmer>And you can check out Steve's story at BioCentury.com.

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<v Jeff Cranmer>That's it for this week.

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<v Jeff Cranmer>We're taking a break next week, we'll be back on the 29th of December.

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<v Jeff Cranmer>And we wish everyone out there a happy holiday season, however you roll, and we'll be talking about some year end stuff and some 2026 2026 preview stuff when we come back December 29th Kendall Square Orchestra provides the music for BioCentury This Week.

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<v Jeff Cranmer>The group 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.