Biotech Hangout

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

[Biotech Hangout @BiotechCH]

https://t.co/owun7mgDnT

[Jennifer Van Laar @jenvanlaar]

He HAD to have known. Start the investigation NOW

[BiotechTV @BiotechTV]

𝐒𝐓𝐈𝐅𝐄𝐋 𝟐𝟎𝟐𝟔: Here's why @Stifel's @TimOpler expects 2027 to be a 'blowout year' for big pharma M&A.

[First Squawk @FirstSquawk]

PFIZER AND BLACKSTONE LIFE SCIENCES HAVE ANNOUNCED A STRATEGIC FUNDING AGREEMENT FOR PFIZER’S OBESITY PROGRAM, WITH BLACKSTONE TO PROVIDE PFIZER UP TO $1.50 BLN THROUGH 2028 AND PFIZER RETAINING FULL OPERATIONAL CONTROL OF ITS BEROBENATIDE PROGRAM

[Mickeychiku @mickeychiku]

Top-notch communication from both today. My assumptions:

1) Ex-FDA GI division reviewers writing/reviewing NDA content. NDA submission in Nov.

2) Looking at Oral combo only. Their own oral α4β7 or IL-23 combo with Obe may be announced in Jan with some cheap Chinese partner. This move makes Gilead, Lilly and J&J oral pipeline and combination redundant. They need to act fast.

3) CD- Can see blinded data from blinded arms. Can see arm 1 (placebo) bad, arm 2 slightly better (12.5 mg) and arm 3 (25 mg) and 4 (50 mg) exceedingly doing well compared to 1 and 2. Not much difference in 2 and 3. That gives confidence in CD.

4) Final CD induction enrollment announcement in Dec. March last 12 week visit. April - May data.

4) They are reading BioX.

[The Biotech Investor @TheBioInvestor]

"Met" is not enough. 86 of 642 readouts filed as met still fell 10%+ vs XBI on day one. Only 6 carried spin. It is an expectations gap; crowding is the tell.

Watchlist and how to read it on the last page. Base rates, not trial reads. Not advice.

https://t.co/PrnbXTOuFH

3/3

[STAT @statnews]

Federal health officials granted blanket ethics waivers to USPSTF panel members, some of whom own pharma stocks and private medical practices. https://t.co/LALQpXzZBF

[dough @semodough]

$PEPG Stifel BUY PT $12 10mg/kg MAD Data a Clear Win, Showing Best-In-Class
Splicing (~47%) While Maintaining Acceptable Safety-Next steps: additional expansion cohort to start, 12.5mg/kg MAD data still on-track for 1H27, followed by an EOP2 meeting with the
FDA in 2H27; also getting OLE data in Jan 2027.

[Bio Stocks™ @BioStocks]

$BNTX to Acquire Priority Review Voucher from $SRRK for $205M in Cash

[Ben Fidler @BentheFidler]

BIO unveils plan for US to remain biotech’s ‘global leader’ https://t.co/1ngSykQkI4 by @gwendolynawu @IAmBiotech $XBI

[Zach Scheiner @zachscheiner]

The October 30th FDA advisory committee meeting convened to discuss our portfolio company Sydnexis’s pediatric myopia treatment SYD-101 had me questioning my sanity and left me worried for the future of innovation in this space. I had to write about it.

https://t.co/KSoRtTBd2p

[Jukan @jukan05]

Taiwanese semiconductor analyst Andrew Lu’s take on the recent scandal involving Jensen Huang:

Why the US Seized on the Scandal to Draw Its Sword: Three Strategic Objectives

The purpose of this scandal is by no means to expose an affair. It is to force through three critical objectives that had made no headway in the tech war between the US and China because Jensen Huang opposed them.

The first cut: Completely destroy the legitimacy of Jensen Huang's lobbying against sanctions in Washington

Over the past two years, the loudest and most influential business leader in Silicon Valley opposing a total ban on chip exports to China has been Jensen Huang. He has told the White House the same thing all along: "Cede the Chinese market to Huawei, and the only one that ends up dead is the American tech industry."

But the moment US intelligence labels the woman named as Huang's affair partner "a spy working for China's Ministry of State Security who sought to steer the US toward easing its chip controls," every bit of lobbying he has done for looser controls takes on an entirely different political meaning. It becomes a national security matter, raising the possibility that a foreign spy used a secret relationship to exert influence.

Huang can no longer say a single word in defense of the Chinese market before Congress or the White House. If he does, he will be branded as someone who "fell for an intelligence operation and still hasn't come to his senses."

The second cut: Reverse the H200 export approvals for China and sever the link between Chinese shell companies and Southeast Asian smuggling networks

Look at the timing of the two reports.

On November 8, the very day the Jensen Huang scandal broke, The New York Times published an investigation for which its reporters went in person to dozens of Chinese companies that the US Commerce Department had approved to handle Nvidia's H200 chips. New Matrix in Beijing was one of them. According to the report, the registered addresses of companies approved to buy the chips turned out to be empty "ghost offices," and some of the companies had close ties to entities on US sanctions lists and to firms under contract with the Chinese military.

One exposé says Nvidia's CEO was having an affair with a female spy from Megaspeed, the Singapore company that handled the chip smuggling. The other says the Chinese companies Commerce approved to buy H200s are nothing but shell companies trading on behalf of the Chinese military. The aim of these two reports is clear. They are meant to pressure the Trump administration and the Commerce Department into fully revoking or freezing H200 export approvals for China and, going further, to force a sweeping overhaul of the loophole that let chips be diverted through data centers run by third parties in Singapore and elsewhere in Southeast Asia.

The third cut: Put Nvidia on a national security leash through congressional oversight and an independent investigation

As the world's largest company by market cap and the dominant force in AI, Nvidia has until now enjoyed broad autonomy in how it runs its business. But in the wake of this incident, the three congressional committees responsible for China, foreign affairs, and intelligence have begun examining Nvidia's internal security measures directly. They have even pressured Nvidia's board into forming an independent investigation committee to look into the company's own founder and CEO.

In effect, Washington's national security establishment has planted a watchdog right inside Nvidia's board. From now on, the goal is to make sure that everything, down to where each and every one of Nvidia's high performance chips ends up, conforms strictly to US national security strategy. It also means there is no more room for skirting the edge of the rules or releasing chips with specs specially tailored to regulatory thresholds.

Conclusion

"The scandal was a detonator set off right on cue. The real goal was to plug the holes chips were leaking through."

Jensen Huang made the fatal mistake of letting his guard down in his private life and personal relationships. In the end, he fell into a honey trap, the textbook tactic of intelligence warfare, and was compromised. America's national security and intelligence agencies ruthlessly exploited the weakness his private life had exposed. As a result, they solved three thorny problems in a single stroke: Nvidia's lobbying at the White House to ease restrictions on China, the flow of H200 chips into Chinese shell companies, and smuggling routed through Singapore.

The closed congressional hearing set for November 18 will be the decisive turning point at which the US moves in earnest to tighten its sanctions on China's AI compute even further.

[Adam May @A_May_MD]

That’s a miss for $ZURA! HS placebo has grown into a real beast. Onto SSc soon then PMR after that. No need to dive into the SSc setup here, because I already wrote about that catalyst in the original document - check there for my takes on that.

That’s 2/3 on pitches! Bummer and of course a big money loser for me, but that’s part of the game. Finding setups with huge potential upside skew means you have to go for stuff that the market thinks is very unlikely to work, thus pricing it cheaply. This time the market was right!

As discussed before, win or lose, the next stop is X hiatus. I’ll stick around for a few days so the “I told you so’s” can take their shots, but a nice break from the noise and distractions is certainly in store.

[Bio Stocks™ @BioStocks]

$ARGX to acquire Unnatural Products Inc. for up to $1.15 billion
https://t.co/JNL45lNaqO

[Axios @axios]

BREAKING: Jensen Huang admits affair as Nvidia launches independent investigation into CEO https://t.co/YnTiS5YMgT

[Persimmon Tree Investments @PersimmonTI]

$VIR

$VIR came to kick some ass, apparently…

a back to de Backer PR:

Vir Biotechnology Announces Expanded Phase 2 SOLSTICE Data for Elebsiran and Tobevibart in Chronic Hepatitis Delta, Showing Deep and Sustained Viral Suppression, and Exploratory Finite Treatment Data

[Biotech Hangout @BiotechCH]

“Radical’s announcement omitted any acknowledgment of Tabula’s work, making it appear it was all its own.”

[Andrew Dunn @AndrewE_Dunn]

George Church estimated he's co-founded 50 startups and advised another 50 over his esteemed career. He couldn't remember any other instance of resigning over trust issues — until this case with Radical Numerics:
https://t.co/H0rVoYfSv4

[Allison DeAngelis @ADeAngelis_bio]

Novartis is largely abandoning an experimental drug analysts once considered a potential blockbuster https://t.co/hBAMCAtPfR $NVS

[Robert Nelsen @rtnarch]

If we ban data centers, the massive investment in infrastructure (trillions) and hundreds of thousands of jobs will just flow to Canada, Asia, Eastern Europe. If we pause AI, we will become a natural resource and food supplier for a dominant China.

[Not Odd @TTRAmyloid]

@adamfeuerstein @BiotechCH 5.9% in a month and it returns capital? Damn the LPs are harsh

[Biotech Hangout @BiotechCH]

Despite significantly reducing Lp(a), $NVS and $IONS pelacarsen failed to meet primary endpoints in a Phase 3 trial. “I think a lot of the companies in the space, like $AMGN, $LLY, $AZN, who are now conducting major studies, are going to really be looking to see any subsets that potentially lead themselves to be more amenable to therapy,” says @YaronWerber. “That's what we're all going to be looking for tomorrow [at #AHA2026], and we shall see if there's any sort of correlation between underlying levels of LDL and risk versus the Lp(a).” #BiotechHangout

[Biotech Hangout @BiotechCH]

On today's #BiotechHangout, @BrianSkorney, @adamfeuerstein, @MatteisPaul & @YaronWerber will cover the election results: what a Dem-controlled Congress vs Trump's veto power means for healthcare & pharma, company news: $VRTX pove PDUFA & treatment halt controversy, $RVMD first Rasonque sales, $NBIX Vykat, $MDGL whistleblower lawsuit, Usona/$CMPS controversy, $SNY stops $NRIX STAT6 degrader program, $NVS Zolgensma update, earnings: $AMGN beats estimates, $ONC BTK degrader progress, data: pelacarsen at #AHA2026, #ASH2026 abstracts ($LEGN vs $GILD update) & much more: https://t.co/8GgJldz4Mi