Biotech Hangout

Weekly discussion of biotech news w/ @daphnezohar @bradloncar @timopler @LifeSciVC, @cngarabedian, top analysts & other biotech insiders

[Biotech Hangout @BiotechCH]

https://t.co/C9MTb4AqSe

[aavg joe @alva_jr1]

The best in bio!! No other space is close in experience expertise and investment opportunities!!

[Adam May @A_May_MD]

Having crossed $200 today, $MRNA is up $68B YTD because of a clinical trial
-from which we have zero data yet,
-in which they were not even comparing their drug to the actual current standard of care
-addressing a TAM that could *optimistically* support peak sales of only $2-$3B
-using a drug that they only own HALF of!

This is, without a doubt, the craziest, most unhinged move in the history of biotech.

I’m not commenting on if it’s a good short, bad short, whatever. EVERYBODY knows that the trading dynamics here are momo/hype/AI trade related. The action on these unhinged moves is impossible to predict as they have no basis in reality.

This is for documenting history. The most insane move in the history of biotech.

[Biotech Hangout @BiotechCH]

$LXEO makes a deal to acquire Mantle for $8.3B, along with four assets in Friedrich’s Ataxia (FA). “We see this as a pretty impressive effort to go about targeting Friedrich’s Ataxia from multiple pathways,” says @BrianSkorney. “In our view, $LXEO becomes the FA company with the most going on. There are a number of other companies pursuing Friedrich’s Ataxia but it's really been -- not necessarily underdeveloped -- but certainly under-treated as an indication and it's been a tough nut to crack clinically.” #BiotechHangout

[Biotech Hangout @BiotechCH]

On today's #BiotechHangout, @SamFazeli8, @BrianSkorney, Matt Gline (@gline) & @YaronWerber will cover market & policy: MFN & revenue sharing, IPOs, $ETRA’s fall despite being upsized, Heidi Overton's FDA confirmation hearing, $CMPX pushes ahead despite FDA setback, stock moves: $OMER, $CGEM, $MAZE, data: $VRTX AMKD data & readthrough to $MAZE, $CLDX Ph3 urticaria data, $VKTX's VK2735 Ph1 maintenance data + capital raise, $AMGN Ph3 Sjogren data, orexin news, $IONS Fusion trial success, why $MRNA stock moves on ESMO news, $ROIV CLE proof-of-concept data, $LXEO's FA expansion, Roche's enicepatide Ph2 obesity/diabetes data, & much more: https://t.co/1LkAcSiu63

[Biotech Hangout @BiotechCH]

$MRNA announced a series of late-breaking abstracts for ESMO in October. “Looking at the share price going up from ~$140 to today, trading at just over $200. It hasn't been at this level for a long while. Now what’s driving it?” says @SamFazeli8. “Well, their presentation for the melanoma data is the number one presentation in the first plenary and I think there's a lot of excitement in there for that. We’ll have to wait and see what the details are.” #BiotechHangout

[Biotech Hangout @BiotechCH]

$ALKS announced positive Phase 1 data for ALKS 7290 in ADHD, marking another recent win for orexin agonists. “Overall, I think it's pretty interesting to see these drugs succeeding in an indication like ADHD,” says @gline. “I think you're going to start hearing about people using these drugs in all kinds of different settings because they seem to have an impact on cognition and sleep and wakefulness and level of energy.” #BiotechHangout

[Biotech Hangout @BiotechCH]

Redemption for $CLDX’s barzolvolimab in urticaria -- the drug met both primary and secondary endpoints in the Phase 3 trial. “This is one of those super, super controversial, contentious stories…the data has always been very, very good on the efficacy side, and Phase 3 absolutely did not disappoint,” says @YaronWerber. “The side effect profile was really not bad at all, even on the hair color changes, which were very subtle, they're all reversible, and skin color changes, no infections at all, and the data is going to be presented probably at the #AAAAI27 Annual Meeting in February.” #BiotechHangout

[Biotech Hangout @BiotechCH]

$VKTX announced topline Phase 1 data for their injectable GLP-1/GIP dual agonist, meeting the “best-case scenario”. @SamFazeli8 summarizes the data: “We're excited by the data that we saw. 19% placebo adjusted weight loss at 21 weeks for the induction phase beats on cross-trial comparisons the tirzepatide data. Then 97% of the reduction was preserved in patients who switched to the lower maintenance doses administered every other week in the subsequent 12 weeks, and then 90% in those transitioning to once monthly dosing. So that's pretty good. Especially when you're looking at a situation where patients are having a tough time staying on the doses that they're starting with.” #BiotechHangout

[Biotech Hangout @BiotechCH]

Promising Phase 3 data for $AMGN’s Sjögren’s drug dazodalibep meeting the primary endpoint. “We've learned at least this Phase 3 study is positive. I think a lot of questions are how positive is it?” says @BrianSkorney. “There's been hits and misses among CD40 ligand-targeted therapy, and, even in Sjögren’s there's been a number of failed Phase 2 studies with different targets and the question is: is this going to be really needle-moving or have they just designed a smart study to get it across the line?” #BiotechHangout

[Biotech Hangout @BiotechCH]

Positive clinical data for $VRTX with their kidney disease drug inaxaplin, with positive knock-on effects for others in the kidney disease space. “This was their first data set that they presented in a broader range outside of the FSGS patients, and it was kind of okay.” says @BrianSkorney. “The impact on proteinuria here was more or less the same impact on proteinuria in the $MAZE non-diabetic cohort. Of course, there are kind of cross-trial comparisons…Probably strengthening the argument that these are going to work outside of FSGS, but maybe also highlighted that diabetes is going to be a much harder hurdle to move the needle in.” #BiotechHangout

[Biotech Hangout @BiotechCH]

$CMPX is pushing ahead with approval application for their cancer bispecific tovecimig, despite FDA recommending a new trial to show overall survival benefit. “I’m not sure if you can read this as the FDA being tough,” says @SamFazeli8. “FDA could have said, ‘we can approve this given the side effect profile isn't particularly onerous, but then you need to do a confirmatory trial that shows OS benefit.’” #BiotechHangout

[Biotech Hangout @BiotechCH]

FDA Commissioner nominee Heidi Overton faced questions during yesterday’s confirmation hearing. “I don't know that she would be the person we would all choose in the scheme of an HHS run by RFK Jr. but she has certainly opposed some of the more extreme MAHA pushes,” says @BrianSkorney. “In her opening remarks, she really talked about speeding through innovation in getting pharmaceutical products and cures out there. So, thematically, I think this is good news.” #BiotechHangout

[Biotech Hangout @BiotechCH]

Potential complications of these types of deals, especially in Europe: “AI and AI businesses are mostly U.S. based and sucking the revenue out of Europe. So, the reality, unfortunately, may end up being that the Europeans just can't afford to pay the extra cash,” says @SamFazeli8. “It sounds awful, right? Because these are advanced first-world countries with first-world GDPs. But if it ends up being in that situation where the only way to deal with it is to limit the number of patients that get access to a drug. Well, that's a really bad outcome from this.” #BiotechHangout

[Biotech Hangout @BiotechCH]

More details emerge on the Trump administration’s MFN deals. “There were a bunch of agreements that were accessed via effectively a FOIA request, and they talked about the $PFE-MFN agreement among them, and obviously a lot of the juicy bits were redacted so it's hard to know exactly what's going on,” says @gline (Matt Gline). “It would obviously be good for the U.S. ecosystem and for the global ecosystem, for the industry as a whole to see some equalization, where the U.S. became a less disproportionate share of the market and we're less levered to policy here.” #BiotechHangout

[Biotech Hangout @BiotechCH]

@SamFazeli8 @BrianSkorney @gline @YaronWerber @EricSchmidt151 @daphnezohar @JMaraganore @LifeSciVC @bradloncar @MatteisPaul @TimOpler @t_lorriman “Long shorts, just seems like everywhere I hear, is really getting kind of squeezed,” adds @BrianSkorney. “Is the degrossing of those long shorts sort of driving the $XBI down?” #BiotechHangout

[Biotech Hangout @BiotechCH]

Kicking off the show this week, the hosts discuss the overall biotech market. “The average money being raised in these IPOs is the highest that we’ve seen ever for the biotech sector,” says @SamFazeli8. “All pretty good signs here in terms of the IPO market, even if the number of deals is not going to be getting anywhere near what we saw [in 2021].” #BiotechHangout

[Adam Feuerstein ✡️ @adamfeuerstein]

One year ago. X poll on $NKTR $LLY judgment. Actual judgment $90M, apparently. The discrepancy is notable.

[Adam May @A_May_MD]

$NKTR awarded $90M in damages in its lawsuit vs $LLY.

Nothing earth shattering. $NKTR walks away +$90M in cash…though their market cap is down nearly $600M since the trial started a little over a week ago 🤷🏻‍♂️. A period during which we also learned through trial proceedings that $NKTR is actively engaged in BD discussions for rezpeg…

My hope is that this trial coming to a (mildly positive) conclusion removes a massive overhang for $NKTR. Stock was >$100 in the recent past, but it’s been a widely held notion that no “deals” could happen while the trial was pending. I have agreed with that. A lucrative deal with another pharma would’ve completely undermined their position that $LLY had damaged them. That limitation is now removed.

We also should have AA off-treatment data any day now. As previously discussed, AA relapses *rapidly* when JAK inhibitor drugs are stopped, and this has massive implications for AA patients, as a full head of hair lost due to an interruption in treatment can take years to grow back. This is NOT like other conditions where you simply go back on the drug and regain the effect right away. Durability of effect, including durability with treatment interruptions that are common in the real world, is paramount.

~$1B EV. A drug for AtD and AA with a unique mechanism. Gotta think there’s strategic interest at these levels 🤷🏻‍♂️

[Robert Nelsen @rtnarch]

It detects the characteristics of more lethal cancers. Not specific cancers. Existing public health and oncology glitterati are so set in their thinking they cannot redefine their definitions. The cancer has a molecular signature. It does not care what ‘super-smart’ doctors name it.