Latest / BioSpace / Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight
Transcript
- Jef: Hello, and welcome to Biospaces the Weekly. I'm your host, Jeff Axt. The biggest news from this past week is that Replimune finally crossed the regulatory finish line, earning FDA approval for its twice-rejected therapy for advanced melanoma. So that was some good news. Last week also saw the last of the major pharma's report second quarter earnings. These included obesity giants Eli Lily and Novo Nordisk, so we will recap those for you. And finally, psychedelics made headlines once again. as Frontrunners Compass Pathways and Dafinian Therapeutics provided updates on near-term catalysts for their psilocybin and LSD-based candidates. Let's get started. Hi guys, good to see you. Annalee Armstrong: Welcome back. gabby: Hi Jeff. Yeah, thank you for being back. Jef: Thank you, thank I am done with travel for the foreseeable future. I am home hopefully forever. Annalee Armstrong: you're not allowed going away on earnings again, but I do hope you had a good time. Jef: I did. It was a family wedding and my kids just danced the night away with other little cousins. It was a blast. So yeah, you guys had a busy week last week with earnings and then Reptomune. You guys sent out a breaking email. I saw those texts come and go while I was busy with family stuff. Annalee Armstrong: We were glad you ignored them. gabby: Heather was on it. She had, you know, the story ready, whether and then she just had to slot in which way it was going to go. So it was good news. Jef: It was really unclear which way it was going to go. We'll get into that in just a minute, but usually we like we know it's probably gonna be approved or probably gonna be rejected and we just write the one pre-write. This time it was really a crapshoot. Annalee Armstrong: Yeah, yeah, we really weren't sure up until it it came in. And I think even I I felt like with that one, no matter which way it went, we were gonna be surprised. But yeah, we're gonna talk about it. So maybe we won't we won't go too far. Jef: Right. Yeah, I was gonna say we're gonna get right into it. Why don't we take a break though and do some introductions? Annalie, you wanna get us started? Annalee Armstrong: Yeah, for sure. I'm Annalie Armstrong. I'm senior editor at Biospace here. and I am in charge of the weekly Biofarm Executive newsletter, which hits your inboxes on Wednesday. Jef: Thank you. And Gabby? gabby: And I'm Gabrielle Mason, senior editor here, and I curate our Gene Pool daily newsletter, and then also our weekly manufacturing brief, which goes out every Tuesday. Jef: Awesome, thank you. And I am once again, I'm Jeff Axt, managing editor. Heather is out on her own vacation this week. So I'll just put a plug in for her newsletter, which is Clinica Space, that comes out every Monday. So getting right back to Reptimune, this is, like I said, the biggest news of the week. Reptimmune has been one of those biotechs that's been on a real roller coaster ride on a through the FDA and all the leadership turnover that we've seen in the past year, specifically for its oncolytic immunotherapy RP1. Which is proposed for the treatment of advanced melanoma. Well, now approved. I'll give away the the punchline there. Was proposed, now approved. So, like I said, this has been through the ringer. This therapy was rejected not once, but twice. That first rejection came down in July 2025, so a little over a year ago. Immediately there was uproar from the community. There was an open letter from 22 researchers involved in the drugs trials urging the agency to re-review its decision. Repimune did resubmit the application for the drug last October, adding some new analyses to the package. That application was accepted and reviewed by an entirely new team of FDA reviewers, only to be rejected again in April. Annalee Armstrong: So both those rejections came down under former Commissioner Marty McCary, right? Jef: Yeah, that's right. And McCarry had publicly defended the FDA's decisions around RP1. So I think the hope was that Rep Immune would have better luck now that McCarry is gone. So the company resubmitted yet again. That application was accepted by the FDA in June, shortly after McCarry's departure. And not only did the agency accept the second resubmission, but it gave the company a relatively short timeline with an early August Padufa date. So it said that Rep Immune should expect an advisory committee meeting, which happened in late July, just three days before that Padufa actually. And those are the the adcoms along with Capricorn that we were talking about the last couple of weeks. So the Rep Immune Adcom was contentious. The FDA said that Rep Immune's melanoma data package was not interpretable. But ultimately the committee voted 10-3 in favor of approval. So again, we weren't really sure whether that would come down given the FDA's stance and then the advisory committee's vote. the FDA is not beholden to follow their advisors, but they often do. under normal circumstances, I should say. And we just really didn't know what was going to happen. So again, the Padufa date was only a few days after this adcom. And it was actually for a Sunday. So we were expecting hopefully a decision by that Friday, really only the very next day. But the FDA took a little bit more time. We didn't know when it was going to come down. So there was a bit of a nail biting wait for Reptimune and the melanoma community. But on Thursday, they finally got to celebrate as the green light was issued. So Replicomune CEO Sashio Patel and the FDA both focused on the really high unmet need in advanced melanoma. So I think it's I think it's a really positive thing. Again, with all of those researchers supporting this decision, even back after the initial rejection, I think this was the answer that everybody wanted. Annalee Armstrong: Yeah, and again, it was one that surprised us. We really weren't sure. and you know, this is also a pretty exciting just achievement for biotech in general. We're starting to see a lot more of these small biotechs go forward and market their own drugs. So that's what Replamune has to do now. With all of this drama behind him, now they get to launch a drug. analysts think this could be a $1.3 billion peak sales opportunity for Replomune, you know. Just focusing on that high on met need in this melanoma population, there really just isn't anything out there. These patients have tried a lot of different medicines, they're on their third, fourth line. you know, this is a really tough space. So Replimune is going to enter that market. executives held a conference call after the approval, and they told investors that they do not think that the FDA drama is going to have any impact on the launch. In fact, they actually had immediate inbound interest from doctors asking them as soon as they heard that the drug had been approved when it was going to be available. I also really love to hear that Repl Immune is actually hiring back a bunch of commercial staffers who had been laid off earlier this year after the FDA challenges. So It's not often we get to report that kind of news around here that there's actually hiring. And specifically, some people are getting their jobs back after they unfortunately had to be laid off because there was so much uncertainty at Replimune. Jef: That is really good news. And it's interesting they say that the you know, the turmoil at FDA was not gonna negatively impact the launch. I wonder if it even might positively impact the launch. There has been so much news around this. Like I said, all those researchers penning the open letter, media outlets such as Biospace reporting on all this news. I feel like RP1 is now known by maybe more people than it would have been otherwise if it had just been quietly approved last July. So who knows? But really good news to hear that it is, you know, full speed ahead for those patients to get this this therapy that they desperately need. All right. Well, now moving on to Q2 earnings. As I said, last week saw the last of the major farmers report, and that included two of our favorites, obesity rivals Eli Lilly and Novo Nordisk. Annalie, let's start with Lily. Did the good news just keep coming? Annalee Armstrong: Yeah, I've been covering Lily for a long time. So it's been crazy to watch their progress, especially over the past maybe two or three years. so basically, yeah, pretty good news for Lily, as always. their revenue rose to $23 billion for this quarter, which was a 48% increase. that's absolutely crazy. Yep, Jef: Grief, yeah. Annalee Armstrong: it seems like every single quarter we're seeing that kind of double-digit increase. this is, of course, on the strength of their diabetes and obesity portfolio, trzepotite is their main product there. they have Zep bound for weight loss and then Monjaro for diabetes. So those are combining for some pretty massive sales. But with that said, that wasn't really the focus. There was a little bit of a miss here, which is kind of surprising and unexpected for Lily. Lily launched an oral GLP one, just like their rival Novo Nordisk. So this quarter, the second quarter was the first quarter for which they were actually reporting sales for this drug. That drug is called Fondeo, and analysts were kind of surprised to see that this drug is not doing as well as Novo's oral Wagovie. Foundeo took in about $98 million for its first quarter on the market, whereas Novo reported $355 million for the first quarter that Wagovy was on the market earlier this year. So really big discrepancy there. So analysts kind of chalk this up to the fact that Lily is really starting from scratch. Novo has the name brand recognition. They were able to go in and basically say, hey, here's Wagovi, you know it, you're taking it. Why don't you switch to the pill? It's the same medicine, same molecule, different formulation. Lily, meanwhile, is starting with a completely new molecule. No one on the you know, marketing side of things ever taken it before. so it's much easier to market the pill version of Wagovi than it is to start from scratch. so that's kind of been the challenge. Executives acknowledged this on their conference call and ensured investors that they're working really hard to build up, you know, brand awareness on the physician side and on the direct-to-consumer side to help more people become aware of this drug. But the good news is that volume is definitely growing. It's likely that that ninety eight million dollar number for this quarter will advance next quarter. so we'll just have to wait and see. Jef: Yeah, it'll be interesting to see how long it takes. I you know, I do think that the sentiment is largely that Lily will eventually overtake Novo. That certainly happened in with their trzepicide franchise. You know, Novo had the lead with semaglutide in their products, but relatively quickly Lily stole a substantial market share from Novo on those products. So once again, a little bit of a head start for Novo and a slow start, I guess, with this launch for Lily. But you know, maybe maybe they still will surpass them at some point. Annalee Armstrong: Yeah, analysts kind of said that Foundo's US performance is uncertain at this point. So Lily has a lot of ground to make up. But you know, the other thing is Lily has kind of this exciting molecule called Reditrutide that a lot of people are looking forward to. It has shown more, I guess, robust or more efficacious weight loss in clinical trials, probably the most weight loss that we've seen with any molecule in the clinic so far. Lily does have that one coming. I think that it seems the analysts are maybe a little more excited for that one than what Novo has coming next, which is Kegrasema. so you know, Lily still has a lot of pipeline to go here. Jef: Analysts are excited and so are consumers. I mean, retatratride Annalee Armstrong: Mm-hmm. Jef: is the one that everybody is, you know, initially there was the reports that one person got this drug, unapproved drug, ahead of time. And all signs pointed to that person potentially being the president. That was never confirmed. But then there was a report recently that more patients are hopeful are eager to get this drug even before it's approved. So yeah, I think you're right that all eyes are on retatratride as like the next big thing in weight loss. All right, so take home message there. Lily is the clear winner when it comes to injectables. We know that, but so far Novo is holding its lead in the oral market. what else did we learn from Novo's call last week, Gabby? gabby: Yeah, so it is interesting because Novo has been hit by, you know, a couple of clinical kind of setbacks since the heyday of the ejectables. So including two head-to-head trials pointing to the superiority of Lily's asset over their own. So obviously we just talked about, you know, how they have a little bit of the market lead on oral pills, but in R D we're seeing Lily kind of take the lead. it also follows non-obesity wise, the late stage IL6 fail that was reported last week in cardiovascular. They were trying to kind of expand a little bit beyond that obesity. but on their earnings, you know, CEO Mazier Mike Dutzar he said failure is basically par for the course in drug development. and that Novo will lean heavily on its early stage pipeline and innovation engine to kind of bounce back from s some of these late stage setbacks. He said, quote, we need to learn from the failures and reinvent ourselves again, end quote. and he also said that Novo's looking for bolt-on opportunities or external kind of possibilities. Jef: Way to really downplay that failure. Yes, failure is a big part of drug development, but that one was was pretty big and disappointing, I think, to the community. So Annalee Armstrong: Not to mention late stage too. You know, farmers Jef: Right. Annalee Armstrong: usually weed that kind of stuff out by that point. Jef: Hopefully they try to. But like he said, learn from the failures. So we'll see what they do next. All right, so we also covered Gilead, Amgen, Biomarin, Denali, among others. So you can check out all of those stories on those earnings reports at biospace.com. But for now we'll move on. Next up on today's agenda is psychedelics. I love how much we've gotten to talk about this space recently. And last week we got updates from both Compass Pathways and Dithinium Therapeutics. So analysts were once again sending us their thoughts on what to expect from these companies. Gabby, you covered those latest updates. What can you tell us? gabby: so the industry is really zeroing in on Dafinium and Compass, these two biotechs, as they await some major catalysts in the next, you know, few days for Dafinium. one of those catalysts is a top-line phase three readout in generalized anxiety disorder for Dafinium's single dose LSD candidate. So earlier this summer, Definium shared late-stage data for that same asset in major depressive disorder and demonstrated an 8.1 point placebo-adjusted change in symptoms over six weeks. So those findings really increased analysts' confidence in the upcoming anxiety readout, which is slated for some time this week. If the findings are positive, like analysts kind of suspect they will be, it likely will, you know, send Dafinium stock up quite a bit. which is saying something because over the last six months the biotech stock has risen more than a hundred and fifty percent. So thinking it could substantially increase more is pretty significant. And then there's Jef: Yeah, there's just been so much positive attention right now to psychedelics, so I can see that. gabby: Yeah, and it will only kind of keep coming, if these readouts are what analysts think they will be. And then on COMPASS's end, they also confirmed that they had submitted certain modules of their rolling new drug application and that the FDA had already reviewed some of the data and even reached out to Compass with questions. So, you know, the agency is actively engaging with the biotech on their synthetic psilocybin asset, which is called Comp360, and that's in treatment resistant depression. So this this update, is pretty important because Comp360 is expected to be the first pure, psychedelic to gain FDA approval, with the new info kind of confirming that the company is on track with its timeline of a potential commercial launch, which could be in the first half of next year. of course, all of that is pending regulatory approval plus scheduling with the DEA, but it appears that things are running smoothly so far. Jef: Yeah, and it confirms that that rolling submission process process is working as intended, with the FDA already taking a look at what's coming in. So that's good. And of course, gabby: Exactly. Jef: these catalysts are coming right as the federal government is throwing its support into the space. We know back in April, Trump issued an executive order aimed at accelerating the path to market for psychedelics. That order resulted in a commissioner's national priority voucher for Comp 3660 specifically. So Compass has a little edge there. so I guess. That one to two month timeline will probably kick in once the rolling submission is complete, but still accelerates that overall review process. The other two vouchers did not go to Definium, but there were two other vouchers in the space. So again, just a lot of support from the federal government. And then at the same time, Health Secretary Robert F. Kennedy Jr. has taken aim specifically at selective serotonin reuptake inhibitors or SSRIs, which are pretty standard care or a staple in mental health care right now. And Kennedy is really taking aim at their alleged overuse, specifically in children, but across the board, these are chronic treatments. And in May, the HHS launched a full campaign to curb psychiatric over-prescribing. So as that effort takes place and they're working to reduce SSRI and other psychiatric drug use, we may have these psychedelics come to market. And one of the major advantages I see to psychedelics is that they're not chronic therapies like SSRIs. As clinical data has shown, they can be more effective, often with just one dose. And often in hard to treat cases. So there's plenty of commentary from doctors and analysts about how psychedelics could really be the next frontier for mental health. in that vein, we are putting together a special edition on the psychedelic space. Well, I should say Heather has put together a great special edition on the psychedelic space. It's coming out on Monday in Clinica Space. If you are not already subscribed, please do that now. The only way to get access to the special edition is through your subscription to the newsletter. And like I said, with all this movement from the you know federal government support to the positive readouts we're seeing from Compass and Definium. And you know, the we haven't even mentioned it this podcast, but we've talked in past podcasts about Eli Lilly's great big bio to Vatai Beckley. That was another big validation for this space. So there's a lot going on in this space. Definitely subscribe to Clinica Space and check that out. And speaking of newsletters, it is time for a little update on what's going on in Biofarm Executive this week. Annaly? Annalee Armstrong: Yeah, I am also working towards a special edition for BE, which will be later this month, which we will take a closer look at AI in biotech and pharma. kind of one of the headliners of that issue is going to be a very cool interview that I did with Insilico Medicine CEO, Alex Zavaronkov. I sat down with him at Bio. Literally in the middle of the conference floor, it was busy, it was crazy, he was dashing from meeting to meeting, but he sat down and chatted with me for quite a while about how he was has turned this small biotech at one point into the AI drug hunter that's become one of Pharma's most sought after partners. So he also promised that there were many deals to come. He said that people were teasing him about running back and forth along the conference floor, but it was bearing fruit, so he was continuing to hustle. and then we have a piece that looks at the broader tech bio segment and how these companies are forcing pharmas to fail fast as they build out their AI technology. So you can check out both of those features and more. we have an edition coming out Wednesday, the day that this podcast drops, but later in the month on August 26th, we're gonna have a special edition that zooms in on AI. You have to be subscribed to Biofarm Executive to get that edition. So please make sure you do that. You can subscribe to all our newsletters at the top right corner of the website. Jef: Awesome. Well, that's our show for today. In addition to subscribing to our newsletters, don't forget to subscribe to this podcast on all of your favorite podcast channels. And we will see you next week.