Latest / BioSpace / AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more
Transcript
- BioSpace Marketing: Hey, welcome to the weekly by Biospace. I'm your temporary host, Heather McKenzie, filling in for Jeff Axt, who, along with Annalie Armstrong, is at Bio this week in San Diego. We'll hear from them a little bit later. But first, Abvi kept the MA ball rolling this week, picking up apogee therapeutics for nearly 11 billion. The new FDA reversal train continues to roll, with Regenics Bio set to resubmit for approval of its Hunter syndrome gene therapy. in the third quarter and Sangamo is declaring bankruptcy with Eli Lily and Estella circling for assets and programs. Let's get into it. Hi. How's it going? Hi Heather. Good. How are you? Good. This is kind of just like a little conversation. Yeah. Did you have a good weekend? I did. We it was ⁓ it was gorgeous weather and ⁓ we took my dad out for for dinner on Sunday night for Father's Day. went to ⁓ a cute little bistro that we like in town here and he had salmon and I had gnocchi. Ooh, that sounds excellent. My dad and I also went to dinner. We went with my sister and we had regatoni bol bolognese. It was amazing. My gosh, and and good Good on you for saying bolognese correctly. I know. Well, I love bolognese. So I hope for the times that I've ordered it that I know how to say it. Yeah, no, that's very important. It's ⁓ yeah, it was a it was it was a nice weekend. It was good to get to spend time with both of my parents. And then we we launched right into this week with ⁓ crazy busy Monday. Yeah, always after a holiday weekend when you're just so relaxed and like chill. And then you go back into the week and there's so much news that comes after holidays. Yeah. It it's kind of fun sometimes, but then you look up at two o'clock and you're like, ⁓ there's my to do list. And it's still missing a lot of check marks. Well, we we got a lot done. We did quite a bit yesterday. We did. ⁓ and and you guys can can read it all on Biospace. But for for those of you who don't know who we are, let's ⁓ go ahead and introduce ourselves. Gabby, you go first. Sure. I'm Gabrielle Mason and I curate our daily Gene Pool newsletter. And I also curate our weekly manufacturing brief, which hits your inboxes every Tuesday. And I am Heather McKenzie and I put together our Clinica Space ⁓ newsletter, which ⁓ which reaches you on Monday mornings at three AM. If anyone ever wants to get up and read it at three AM Eastern, it'll be there. I'm always up reading it. 3 AM Eastern Heather. I'm glad to hear that. Well, let's get into let's get into it. So Abbey kept the the 2026 MA train rolling, picking they picked up Apogee Therapeutics for around ten point nine billion dollars. And the deal, it was it was widely rumored to be a sure thing on Friday. I think they were just stotting the I's and crossing the T's, but it ⁓ came to fruition on Monday morning and was announced. Yeah, so this deal gives Abbey apogee's IL23 blocker. So that kind of bolsters AV's already, you know, very heavy immunology expertise from, you know, Sky Rizzy and Rinvoke. So the new acid is a monoclonal antibody that's being developed for atopic dermatitis. It's a mid-stage drug. It's thought to potentially differentiate itself from the already approved dupixant. which root regenerant and Synofi cell in a more kind of convenient dosing profile and appears to have kind of slightly improved efficacy. Yeah, you know, it's really interesting. As much as Abby has kind of ⁓ had a campaign in the past year or so to to be known for more than immunology, they've really doubled down on it here, which is ⁓ which is good to see because when you do something well, you should keep doing it. If if it's ain't broke, don't fix it. Exactly. The this is really ⁓ this also kind of speaks to a major comeback trend for MA ⁓ that this happened ⁓ so far this year. You know, we had GSK earlier this month ⁓ paying ten point six billion, ⁓ so close to the ⁓ closely AVI deal ⁓ for New Valent Bio and its ⁓ precision oncology candidates. And Lily has spent a whole GLP one gold mine worth of cash on several smaller transactions as well. They were already up to nearly twenty one billion by the end of April. API's ten point nine billion ⁓ for apogee has actually displaced that GSK Newvalent deal as the year's second biggest behind Sun Pharma's eleven point seven seven five billion ⁓ gamble for organon in April. And it it's actually really the the largest in what I would call quote biopharma proper. And a huge thing kind of driving this MA activity and uptick is our patent cliffs. So for example, AB, you know, obviously just announced that apig apogee deal. They lost exclusivity of Humera in 2023 and built a lot of strategy around its IL twenty three asset Sky Rizzy. So, you know, this is an expansion of that successful strategic kind of focus. But this basically impacts, you know, every big pharma, including Merck, obviously with. Petruda, Amgen, and Sonofi, to name a few others. Yeah, I mean, I think it's just a cycle of of drug development, right? I mean, you your your biggest products are gonna come off patent and and it just shows that even when you you have kind of successfully traversed that cliff, like like like Abbey is is already kind of being known as an example of a company that's done that, but they still have to keep working because you've still gotta rebuild that pipeline and And yeah, so you know, hopefully it continues ⁓ this year. Love seeing love seeing that kind of money just pumped into an asset, you know, for for inflammation, for cancer, just because ⁓ it it shows how much the companies really, really believe in them. Well, Santa Fe just had some pretty big news too about its pipeline. Yeah, so they just announced a new RD chief, actually, Human Ashrifine. Fionn is leaving after less than three years in the role. And Paulo Fontora is taking his place. So Paulo used to be the chief medical officer at AI Biotech Sara, which they pretty notoriously like raised $1 billion when they emerged, but they've remained pretty tight-lipped about their RD efforts since then. So, anyways, he's coming to Santa Fe in September and he'll report to new CEO, Balen Garrillo. So analysts weren't Super surprised by the move, citing some recent RD disappointments and the new CEO's agenda to improve the pharma's pipeline prospects. So basically her main goal is to bolster the company for when DuPixent's patent expires in 2031. Yeah, I I'm not surprised that she is making early moves. I I I think everyone wants to put their stamp on a company when they come into it, but good luck to good luck to Santa Fe. Pivoting to the regulatory space now and Pivot is the appropriate word here. Regenics bio and unicure are the latest rare disease biotechs to climb aboard the FDA's new regulatory reversal train. Well, wasn't this train kind of already reversing last year? It was, but now it's pivoted and it's going in a different direction. this time the reversals are actually in the company's favors, ⁓ and and hopefully the patients' favors. So last Wednesday, just after last week's episode dropped. Of course, because that's what always happens. Unicure announced it would submit for approval of its Huntington's disease gene therapy in the third quarter of this year. So this was apparently after yet another FDA reversal in this controversial case. And if you're not familiar with the Unicure case, ⁓ Marty McCary and Vinai Prasad, their FDA Had insisted that Unicure run a shame controlled phase three trial of the gene therapy. And this was was after Unicure had apparently originally already agreed with the FDA in 2024 that their phase one, two data could stand as for for an application for approval. But anyway, last week, the new FDA agreed that these three year data, these exact same data, could support accelerated approval. Which is basically exactly what Unicor had been asking for in the first place. So last week in in one of my pieces, I asked who's next. And Regenex Bio answered your question on Monday. The FDA rejected the company's gene therapy for Hunter syndrome back in February, kind of taking issue with eligibility criteria and external controls that were used in the registrational trial. At the time, the agency wanted Regenex to use and approach. Appropriate untreated control. But so after an appeal by the company, the FDA is now saying the original data is sufficient for an application and under accelerated approval path, and that no additional studies are required. So now Regenix Bio, you know, plans to submit for approval also in the third quarter. Yeah, I mean, in in in my editorial last week, I also asked the question at the end. What's what's a biotech company to do? Because they're getting one piece of advice or guidance from the FDA in 2024. They get completely something else last year. And then they're getting basically whiplash right now. So while this might be a good form of whiplash, ⁓ you you just have to wonder if you're a rare disease company, is this is this just under the FDA in in its caretaker mode under Kyle Diamantis, the acting commissioner, or is this gonna stick? Well, these These also aren't the first announcements that have hinted at a new rare disease perspective at at the FDA, though. So replimune and disc medicine have also reported positive regulatory news since Marty McCary's departure in early May. ⁓ but really Unicure Virgenics Bio might be the most obvious reversals. And now, for a special treat, we'll send you over to San Diego, where Jeff and Annalee are enjoying the gorgeous weather and some great discussions. Hello, Jeff Axe here with Annalee Armstrong. How you doing, Annalie? Hi, Jeff. It we are reporting live from bio here. We have found what we thought was a quiet room and then we're starting to hear some sort of party next door. So I think it just really reflects the positive environment that we're seeing here ⁓ in San Diego. Yeah, and we're any of the the nearing the end of day two and I think there may be some celebration starting to pick up as the social hours start. but yes, definitely a more upbeat, optimistic vibe than we've seen in years past. Yeah, it really started at JP Morgan. We started to hear that cautious optimism and it's been really great to see that continue into ⁓ June, which is, you know, the last month of the first half of the year. So some real good stuff happening across biotech. We're hearing it in every session. ⁓ but as we're also learning, we are kind of reflecting on twenty twenty five, and hearing a little bit more about how the FDA disruption has impacted biotechs, how things like the drug pricing policy has impacted deal making. ⁓ so we're learning a ton here, ⁓ and there's gonna be a lot of coverage to come at Biospace. Yeah, I mean I've been really kind of tracking the FDA panels here, a lot of discussions among former FDA and other HHSers as well, former NIH, former C D C and yeah, there's a they're pretty candid about everything that has gone down in the past eighteen months, much more so than last year when I think they were a little bit still shell shocked of what was going on. So a lot of very pointed critiques of how HHS has changed in the last year, but not necessarily of the policies themselves, but more how they've been implemented. The panel I just came from, there was a lot of talk about how we were always hearing about transparency, this transparency, that. But the sentiment was really force transparency. We're going to force this transparency without doing it in a transparent way. It was very hypocritical in that sense. The specific example in that case that was brought up was the release of the CRLs. So yes, they published a bunch of, you know, these complete response letters to have this quote unquote transparency, but Nobody knew it was gonna happen. It blindsided the industry. There was no transparency about why the change was made. And according to some of the former FDA lawyers that were on that panel, it wasn't even legal. Like it was not the right way to go about it. So again, a lot of candid remarks about not great things within the HHS, but as you said, a more optimistic tone. All of these discussions ultimately come down to well, where are we now? And it's already starting to feel like there's a little bit of rebuilding going on. Yes, absolutely. I'm definitely hearing ⁓ a lot of up optimism about the FDA with the leadership changes. Actually, luckily you are going to go ahead and do a session later today with all a bunch of acting directors, which is super exciting. We're gonna hear straight from those people. ⁓ so really looking forward to that. ⁓ so while Jeff has been doing the regulatory track, I have been firmly on the business track. so I have been attending panels on the IPO situation ⁓ and MA. ⁓ ⁓ yesterday I attended a session ⁓ where ⁓ they really kind of got into all pieces of deal making, but one thing that really stood out to me was how the most favored nation drug pricing policy has just completely changed the way that deal making is happening behind the scenes. ⁓ in this panel there were lawyers and biotechs and and people across the spectrum and really what they said is they don't know what this policy is actually financially going to cost them, but they're still considering it when they are signing deals. And they're doing things that they wouldn't have done before. Like they are including renegotiation ⁓ clauses which will allow them to revisit the deal, come back to the table, which is something you don't want to do when you're signing a c a licensing collaboration, an MA deal. So that's the kind of stuff that has come out since MFN policy. And it kind of is funny because President Don Donald Trump has self-proclaimed himself the deal maker in chief. So he inadvertently has completely rewritten the rules for biopharma. deal making. So that was kind of one of my favorite sessions. This afternoon I just stepped out of a panel on IPOs and how to kind of prepare your biotech. I heard a lot more about how dual track processes, which is when you're trying to go for an MA and an IPO at the same time, have basically become triple track. So now that third track and there's a lot of debate about what that third track is. It can be a reverse merger. It could be a SPAC process it could be a collaboration deal. But Basically biopharma leadership is having to go out and prepare for every possible scenario in terms of a deal. So that gets complex, as you can imagine. ⁓ but that is the reality ⁓ of today. So look ⁓ out for some stories on all of these issues coming as soon as we can, right? So the faster we can get them out the better. I mean I think it all comes down to How quickly can you change a massive government organization or a massive industry like biopharma? So it actually just came up in the session I was just in. Janet Woodcock, a formerly of the FDA, always referred to it as this big ship, and they don't turn on a dime, and neither does the industry. So I feel like we were trying to turn really quickly with some of the changes coming fast and furious last year, and now we're catching up and and along with that turn, s maybe we're actually gonna fully shift in a positive direction, you know, by the end of this year, going into next year with industry digesting some of the changes that are coming our way, both in terms of the policy on the pricing side, in terms of the policy in in regulation and working those into the deal making. Everything is renormalizing, I guess. And then hopefully we will be headed in a new direction, a positive new direction. Well and that kind of juxtap juxtaposes wow, that is a tough word with what is happening ⁓ with the rise of China innovation. I met with a delegation from Hong Kong this morning who ⁓ talked about how as all of this debate is happening about how we address China Hong Kong is kind of ⁓ emerging as a bit of a bridge between China, like the global biopharma ⁓ industry. ⁓ and they were saying that yeah, like it it actually has changed like so quickly on the on the ⁓ side of innovation, ⁓ with how quickly China has risen. and it's it's hard to keep up, but you've been forced to. Small biotechs now have to contend with this new competitor that they they wouldn't have to. They have to have the right teams in front of them from the get-go, from the startup point to make sure that they are ready to compete in this area. But they also have to see this as a collaborative opportunity. ⁓ so I talked to a lot of ⁓ startup ⁓ incubators and that kind of thing ⁓ who told me how ⁓ small biotechs startups are preparing for this new reality. Just gonna be have to something that we have to continue to watch and continue to track. Again, not turning them dying means there's gonna be a lot of months of tracking how this is evolving. But ⁓ yeah, optimism. I like it. Yeah, yeah, it's it's been really good. I'm looking forward to hearing more positive stories here. Yep, we have a couple more days left. We'll give you more updates next week, but for now back to you, Gabby and Heather. Welcome back. We hope you enjoyed that ⁓ little update. So back to the FDA, we've spoken a lot on this show about the agency's Commissioners National Priority Vouchers ⁓ program, which was implemented last June. And now the program has come under even more fire. It's been controversial from the beginning. ⁓ you know, people being concerned about transparency, ⁓ especially when it comes to candidate selection ⁓ for the vouchers. But last week, a memo by current acting cedar director Michael Davis was published, pushing back against attempts by former acting Cedar director Tracy Beth Hogue, so his predecessor, ⁓ to prevent approval of Sanafi's type one diabetes drug, T Sealed, which was actually one of the first drugs to receive a voucher on October. So HHS, I think this is a really that was a real benefit ⁓ that that Michael Davis put put this policy. briefing out there for transparency because it really shows the the inside of the process. But in other FDA news, the FDA also unveiled a clinical trials initiative yesterday along with HHS. ⁓ this is part of a a broader attempt by HHS to really speed drug development. ⁓ but the the FDA's new pilot program would actually leverage collaborations with US research int institutions to reduce early trial timelines by as much as a year. They're also looking to shorten the time between drug identification to phase one. And this is all aimed at really reshoring early stage trials from China and other countries overseas, is how Secretary Kennedy put it in the announcement. Well, finally, we don't want to leave you without an update on Eli Lilly. So here it is. A new report from Evaluate projects Lily's terzepatide brands Monjaro and ZeppBound will top the top. 10 biggest drugs in 2032, with more than 70 billion, more that is more than 70 billion in sales. And Lily's new weight loss pill, ⁓ Foundayo, which was just approved in April, also made a valuates list with a projected 25 billion plus. I'm I'm glad you repeated the 7D billion because the the numbers are just unreal. It's almost, I mean, it's hard to fathom that much. It really. Is. It's also hard to fathom ⁓ six years from now. I I'm terrible at five year plans. I don't know about you. Yeah. Five year plans, ⁓ we take it day by day over here. Yeah, exactly. A real real-time kind of team, yeah. ⁓ but of course, you know, that's not the only Lily news. The pharma is also bidding on some of Sangamo's assets amid the biotech's bankruptcy filing. So Lily wants to pick up three of their platforms. plus an early stage AAB gene therapy program. Estellis also put in a bid for Sangamo's Fabray D disease therapy, which Sangamo is currently in the process of submitting a rolling biologics licensing application with the FDA for. So because of the bankruptcy filing this week, the two pharmas have agreed to be stalking horse bidders, which means they get the first baseline bid in a court supervised auction. Sangamo has several other assets that will also, you know, it will try to sell off during the auction. But this at least is a guarantee, you know, a purchase for the programs that we just mentioned. I love that term stalking horse. It just it sounds so mysterious. And I just get these little like rocking horses in my head when whatever whenever we talk about. Scary movie rocking horses. Like the scary ones in the dark rooms with the sh with the shadows. And yeah. Well We will leave you with that happy thought and enjoy ⁓ the rest of your summer week, and we will be back with you next week.