Biotech Hangout

$MRNA stock reacted positively this week to the announcement that they’re working on a Hantavirus vaccine. @SamFazeli8 says, “This thing is so far from being eligible for causing a pandemic, but of course it's a virus, it does mutate, it does cause issues if it gets into enough people and allow it to jump from person to person, but it's very hard for it to jump from person to person.” On the potential development of a vaccine, he adds, “[mRNA] is the right technology to be using, and it's the easiest and most rapid to scale up. I'm assuming it's not unfair to say there has to be some value ascribed to that, as long as the regulators and healthcare bodies don't keep trashing the technology. So, time will tell.” #BiotechHangout

On today’s #BiotechHangout @SamFazeli8, @biotech1 (Josh Schimmer), @EricSchmidt151, & @t_lorriman will cover deals & financings: $BMY/Hengrui up to ~$15B partnership deal, $ARVN/ $PFE $85M upfront licensing deal w/$RIGL for newly approved Veppanu, Isomorphic’s massive $2.1B Series B, policy & regulatory: Makary’s resignation & what this means for biotech, plus company news & data: $BIIB tau data, $INBX interim Phase 2 data & major stock shifts, $MRNA Hantavirus vaccine, & what’s hot at #ASCO2026, #ADA2026, & #EHA2026 & much more: x.com/i/spaces/1njol…

Encouraging mid-phase data for $INBX Head and Neck Squamous Cell Carcinoma candidate suggest its hexavalent OX40 agonist may succeed where previous iterations failed. @EricSchmidt151 notes: "There's a good Phase 2 study here, so give the folks at $INBX credit, they've done a randomized controlled Phase 2 study, and head and neck cancer randomized to Keytruda, and they doubled the response rate. So that's not bad.” #BiotechHangout

“$BIIB seems to be a moth to a flame when it comes to Alzheimer's, despite getting burned multiple times by that same flame,” says @biotech1 (Josh Schimmer). “Biotech companies that are lucky enough to get drugs approved and become profitable are now businesses. And as such, the right strategy for these companies is for the risk tolerance in terms of innovation and capital allocation to fall substantially and act more like businesses -- really thinking about driving top- and bottom-line growth without excessive risk, without wasting excessive capital…But many of these companies are just kind of stuck in the ‘we're biotech companies, we spend a lot, we take risks’ and they do so at not only their own peril but the peril of the industry in general.” #BiotechHangout

Despite missing its primary endpoint, $BIIB and partner $IONS are pushing ahead with their Alzheimer’s tau program, based on encouraging data on cognitive benefits. @EricSchmidt151 notes, “They’ve shown in both the Phase 1 study and, just this week, a Phase 2 study that it has the ability to reduce tau… Despite missing the prospectively identified primary endpoint, which was having to do with dose responsiveness, $BIIB made the decision to move into a Phase 3.” @t_lorriman cautions, “I think the drug is clearly having an impact on tau, but whether tau production will have an impact on the disease is still unknown.” #BiotechHangout

$RGNX’s Duchenne (DMD) gene therapy achieves its primary endpoint in Phase 3. @t_lorriman summarizes the data and the source of investor uncertainty: “They showed a correlation in nine patients between two scores - microdystrophin expression, and then NSAA, which is the functional endpoint in DMD, and their argument is that these can serve as strong evidence for accelerated approval…But what about the other 20 patients? That’s a key point of uncertainty. And then there's this question of is the FDA going to recommend a randomized controlled trial or are external controls going to be sufficient? And together, with some FDA uncertainty, there are a lot of investors not willing to give the benefit of the doubt.” #BiotechHangout

.@t_lorriman on the impact of Makary’s departure on biotech investing: “[Does the] change really impact our investing? Not at all. I think, if anything, the extent to which Makary was in the news and being loud about what the FDA is doing, probably worked against him more than for him. And I think that while a lot of the approval decisions ended up being ones I’m not sure everyone agreed with, they're also understandable, right?” #BiotechHangout

Makary is out of the FDA after just over a year as commissioner - what does that mean for the biotech industry? @biotech1 (Josh Schimmer) says, “It's interesting, right? Because what you read in the press is a little hard to interpret. Was this him not following all of RFK Jr’s whims and beliefs and views, in which case, why would we expect anyone better than Makary to come in to lead the agency?” #BiotechHangout

London-based AI drug discovery engine Isomorphic labs announced a $2.1B Series B. @EricSchmidt151 says, “This isn’t the first time we've seen big tech wade into healthcare waters, right? Whether it's IBM or Amazon and other initiatives in the past, they've started with a bang, like this seems to be doing, and ended with a bit of a whimper. The divide between tech and healthcare, I think, is still very great…Isomorphic has a certainly valuable technology and turning it into a drug development business is a huge, huge gap that just hasn't been breached by anyone else before.” #BiotechHangout

.@SamFazeli8 concludes the discussion on China with an observation about appetite for risk and innovation in China vs U.S.: “Human brains over there are as good as the human brains over in the U.S…So, will they be able to get to the absolute early innovation stage? We know for a fact that they've been able to do that in the material sciences world and the chemistry world. So, there's nothing stopping them - it just needs a different level of risk appetite.” #BiotechHangout

Thinking about the strength of the U.S. capital markets, @EricSchmidt151 observes: “A really, really important topic is the strength of the U.S. capital markets, right? That may actually be our best defense in terms of protecting the U.S. biotech ecosystem. There's no capital market in the world like that… I just wonder whether it is possible for Chinese companies to truly penetrate the US from a capital market standpoint.” #BiotechHangout

Following a visit to China @biotech1 (Josh Schimmer) shares insights on China’s capabilities, “Really is impressive seeing it firsthand, including Hengrui, and understanding that the pace, speed, quality, caliber, affordability of innovation there. It really brought to life a lot of the discussions that I've been hearing about China being a competitive risk to the US.” He adds, “The innovation may be increasingly shifting to China-based companies, at the same time China is going to open up its own markets for innovation and pay more for new, innovative drugs.” #BiotechHangout

What are the potential consequences for U.S. biotech if China’s innovation goes global? “Will it basically be a manufacturing and sales reps?” asks @t_lorriman. “I think that's kind of a bleak view. I like to think that U.S. biotechs are really competitive and want to win and want to make great drugs and will figure out ways to do that. Maybe that means they're going to have to do more in China in order to be competitive.” #BiotechHangout

Kicking off today’s show, the hosts talk about some recent deals, including another big deal with a China biotech as Hengrui and $BMY agree to terms. @SamFazeli8 notes: “This continues to show the trend of outsourcing some early drug development to what I would call potentially still a cheaper and faster country for early-stage drug development…and to co-develop select assets and have the potential to conduct certain commercialization activities globally with $BMY. That's the interesting part that I've not seen before.” #BiotechHangout

Noooo grey market peptide vendors wouldn't bait and switch noooo this must be a mistake. >Am I reading this correctly? Tirz not reta?? >No. The HPLC must be wrong. Ship it.

I wonder do the VCs buying China assets to flip to Pharma get eaten by Pharma just going direct to China assets

🇺🇸 🇨🇳 TONIGHT: I’m honored to join @tracegallagher & an amazing group of guests & journalists on a special 2 hour edition of @foxnewsnight starting an hour EARLY (7p PT / 10p ET) to discuss the historic US/China summit. I’ll be discussing how China is threatening to overtake the U.S. on life science innovation & manufacturing, and how the US administration can address that through investment & regulatory changes.

An appeal to @realDonaldTrump from those of us developing potentially life changing medicines. The next @US_FDA commissioner should have: deep regulatory experience, a track record of reform, and the ability to lead a scientific institution under political & competitive pressure without compromising speed or rigor nopatientleftbehind.org/fda-recommenda… Rick Pazdur is one exemplary candidate and the industry looks forward to supporting whoever is appointed. Thanks to @NPLB_org & @PeterKolchinsky for initiating - please sign & share.

My take on Makary's resignation: Makary had good ideas, and I think he genuinely wanted to bring change to the FDA to make it more nimble. But... 1) He tried to implement policy changes by decree - via publication in paywalled journals. Historically, FDA policy changes go through multiple rounds of comments for refinement and to build stakeholder support. 2) Perhaps his biggest mistake was hiring Vinay Prasad as his right hand man to implement his ideas. Prasad is philosophically against Makary's initiatives. Vinay Prasad was never going to sign off on any plausible mechanism approvals for rare diseases. What you had was Makary saying one thing (make rare disease approval easier and quicker), and Prasad doing the opposite. On top of that, Prasad was a chaos agent at the FDA. In the end, that chaos tracked back to Makary causing his downfall.