👋 Hey, let’s get into it. Lilly just added $5.5 billion to its annual revenue forecast. Most companies would call that an entire business.

Q3 revenue hit $24.4 billion, up 39% from last year. Mounjaro and Zepbound brought in $16.1 billion between them, nearly two-thirds of the total. But the supporting cast showed up too: revenue from newer oncology, immunology, and neuroscience drugs doubled compared with last year.

Lilly now expects $91 billion–$92 billion in revenue this year. Meanwhile, Novo reports earnings tomorrow. Imagine waiting to give your presentation while the person ahead of you gets a standing ovation.

🧪 RFK Jr. Pushes Easier Access to Six Unapproved Peptides Despite FDA Staff Objections
RFK Jr.’s HHS has published a draft policy to ease access to six unapproved and unproven wellness peptides. HHS says it doesn’t intend to take enforcement action against licensed pharmacies compounding BPC-157, TB-500, and four others under patient prescriptions and specified safeguards. It argues that offers a more controlled alternative to gray market suppliers. But AP reports FDA staff overwhelmingly opposed the move, citing insufficient safety and efficacy evidence. Under the policy, pharmacies must verify ingredient quality and report serious side effects, but the peptides remain unapproved. Easier access is moving considerably faster than the supporting evidence.

💸 AstraZeneca Targets $1.5B in Annual Savings to Fund Its Pipeline
AstraZeneca wants approximately $1.5 billion in annual pretax benefits from a restructuring program, with the gains intended principally for reinvestment in its development pipeline. Getting there could cost up to $2 billion upfront, with activities substantially complete by the end of 2029. With more than 180 pipeline projects, the company has plenty of places to put the money. The challenge is turning operating changes into recurring benefits without disrupting the work they’re meant to support. No company-wide layoff total was announced. Corporate math: sometimes saving money requires spending $2 billion first. Basically, the same logic I use to justify guac at Chipotle: “Sure, it costs extra now, but think of the long-term healthcare savings.”

💉 BioMarin Signs Deal Worth Up to $475M for Subcutaneous Fabry Therapy
BioMarin licensed an experimental Fabry disease treatment from GC Biopharma and Hanmi for $70 million upfront, plus up to $405 million in milestones and royalties. HM15421/GC1134A is a long-acting enzyme replacement therapy in Phase 1/2, designed for subcutaneous administration. Fabry disease involves a missing or deficient enzyme that lets certain lipids accumulate in cells. Replacing it through a different delivery route could ease treatment logistics if trials succeed. BioMarin gets worldwide rights excluding Korea. The route is the practical selling point, but its convenience and clinical benefits still need to earn their place in the label.

🤝 Fresenius Secures Options for Up to 37 WuXi Biosimilars
Fresenius secured options for up to 37 biosimilar candidates from WuXi Biologics over the next decade, potentially expanding its marketed and pipeline portfolio from 29 molecules to 66. Initial work is expected to target versions of Polivy and Tepezza. According to Fresenius, the targeted original branded drugs represent more than €370 billion ($414B) in sales measured at list prices. That’s the market opportunity, not the deal’s price tag. Fresenius will select programs and pay development fees, retaining global commercialization economics and manufacturing choices. Development and approvals still lie ahead.

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📈 AbbVie’s Skyrizi and Rinvoq Bring $8.5B in Quarterly Sales
AbbVie’s Skyrizi and Rinvoq generated a combined $8.5 billion in quarterly sales, continuing the immunology handoff from declining Humira and raising questions about future growth.

🤖 Flagship Combines Three Platforms Into One AI Drug Discovery Company
Flagship combined Cellarity, Etiome, and Empress platforms into Etcelera to improve drug development predictions using human biology data.

💰 Biogen Reports Highest Quarterly Revenue Since 2020
Biogen’s Apellis buyout helped lift quarterly revenue 11% to $2.8 billion, its highest since 2020, with a full quarter of acquired-product sales.

⏸️ Gilead Pauses Two CAR-T Trials Over Severe Neurotoxicity
Gilead disclosed partial holds on two KITE-753 lymphoma trials after severe neurological events in some participants, with no deaths reported in its disclosure.

📉 BMS’s Cobenfy Posts $57M Quarter, Missing Expectations
BMS reported $57 million in Cobenfy sales, $11 million below analyst expectations, as management described inventory and prescribing challenges.

💊 InventisBio’s Pill Cuts Psoriasis Severity by At Least 90%
InventisBio reported over 70% of patients in both nomelcitinib groups achieved at least 90% psoriasis severity improvement at week 16 in China’s Phase 3.

🛒 Sanofi Expands Its Search for Pipeline Deals
Sanofi is increasingly interested in late-stage and commercial medicines, alongside selective opportunities beyond its core areas, while cautioning against expecting immediate large deals.

🛑 Geron Stops Phase 3 Myelofibrosis Trial Sending Shares Down 20%
Geron stopped its Phase 3 myelofibrosis trial for survival futility, sending shares down 20% in early trading. No new safety signal emerged.

Akeso’s ivonescimab is becoming the person everyone wants to sit next to at the oncology conference. AstraZeneca, Pfizer, and Revolution Medicines are all testing combinations with the antibody through Summit. U.S. approval is still pending, but the partnering calendar is looking healthy.

The attraction starts with its two-target design. Ivonescimab blocks PD-1, helping release a brake on immune responses, and VEGF, which supports blood vessel growth. Developers want to see whether adding it to their own cancer drugs produces better results. A successful pairing could give both medicines a bigger role in treatment.

AstraZeneca backed that ambition with a $2 billion equity investment in Summit, which closed in October, plus cancer drug combination plans. Pfizer’s antibody-drug conjugate collaboration dates to 2025. These earlier agreements are attracting fresh attention as a regulatory decision approaches. The enthusiasm is real, but the combinations still need to prove themselves.

Summit’s pending U.S. application covers ivonescimab plus chemotherapy after EGFR-targeted treatment in advanced non-squamous non-small cell lung cancer, with an FDA goal date of November 14. It rests on HARMONi, a global Phase 3 trial comparing that combination with chemotherapy alone. The combination delayed cancer progression, but its original overall-survival analysis missed statistical significance. Later follow-up produced a nominally significant global result without changing that original outcome. Summit says the FDA has indicated a statistically significant survival benefit is necessary here.

A separate global Phase 3 trial, HARMONi-3, tests ivonescimab plus chemotherapy against Keytruda plus chemotherapy as the first treatment for metastatic lung cancer. Its squamous and non-squamous groups have separate analyses. Earlier China-only results don’t settle that global comparison.

For partners, the appeal is getting their drug into tomorrow’s treatment regimens. For Summit, it’s becoming the partner those regimens are built around. Everyone wants an alliance, but patients still need the trials to show why.

This is the proportion of 959 surveyed U.S. adults who reported ever exaggerating or inventing symptoms to obtain antibiotics. An odd drug class to run a con for. But we all know someone whose answer to every illness is antibiotics. Cold? Antibiotics. Allergies? Antibiotics. Sprained ankle? Antibiotics.

Here’s what biotech Redditors are talking about:

💸 Are Lilly and Novo Employees Getting GLP-1 Rich?
A Redditor asked the obvious question: with Lilly and Novo bringing in all that GLP-1 money, are employees raking it in too? Redditors claiming to work at the companies described rewards ranging from six-figure bonuses to free cupcakes. Quite the compensation range. Anonymous anecdotes aside, it’s an interesting question: does blockbuster success reach the people doing the work, or does most of the financial upside stay with executives while everyone else gets cake? “Congrats, revenue per employee hit $2 million. Feel free to have two slices.”

😬 Biotech Reddit Has Thoughts on Anthropic’s Mithril Acquisition
Remember Mithril, the one-person biotech startup Anthropic acquired that we covered last issue? Biotech Reddit thinks the pitch misses the point, a criticism commenters extend to AI drug discovery generally. Faster literature searches and less paperwork are handy. The hard part? Years of lab work, failed experiments, and clinical trials to establish whether a drug actually helps people. And “one person” meant one full-time employee, supported by consultants and 11 outside labs. So maybe don’t quit your job to build the next one-person GLP-1 startup. But if you do, let us know. We’d love to write about it.

🤖 NVIDIA’s BindClaw Turns Prompts Into Lab Tested Protein Binders
NVIDIA’s BindClaw team reported 15 of 18 designs bound calcium-loaded calmodulin in a human guided experimental campaign.

💍 Oura and UC San Diego Will Test Wearable-Guided Obesity Care
Oura and UC San Diego will study wearable-data dashboards alongside coaching for people starting GLP-1 therapy or undergoing bariatric surgery.

🌊 Pfizer’s Flooded India Plant Faces a Recovery Into 2028
Pfizer’s best-case outlook has phased supply restarting in mid-to-late 2028 at its Ahmedabad, India, joint-venture plant after July’s flood, underscoring the lengthy recovery ahead.

💰 Dren Bio Raises $350M to Advance Its Cell-Depleting Antibody
San Carlos-based Dren Bio closed a $350 million financing co-led by Juvia Group and Lightspeed Venture Partners. Its lead candidate, dibotatug, targets CD94 to deplete disease-driving cytotoxic immune cells and is being studied in cytotoxic T-cell lymphoma and large granular lymphocytic leukemia. The money will support later stage development, broader pipeline work, and potential launch preparation. The antibody remains investigational. That’s substantial financial runway, but clinical results will determine whether Dren gets to build the destination it’s planning for.

🧠 November 3, 1906: Alzheimer Presents the Case That Will Carry His Name
On this day 120 years ago in Tübingen, Germany, Alois Alzheimer described Auguste Deter’s progressive memory loss and behavioral changes alongside plaques and tangles observed in her brain after death. The presentation drew limited attention. His written account followed in 1907, and Emil Kraepelin introduced “Alzheimer’s disease” in his 1910 textbook. Connecting symptoms with microscopic pathology helped establish a research foundation still shaping neuroscience. A useful reminder for anyone leaving a quiet conference session: immediate audience enthusiasm is a poor measure of lasting scientific importance.

Between Lilly adding $5.5 billion to its forecast and Reddit debating whether employees are getting GLP-1 rich, I keep thinking about the people who joined Lilly 20 years ago. They probably figured they’d found a steady pharma job with decent benefits.

But if they received company stock and held onto it... I just want to say I hope they’re enjoying this newsletter from their beachfront home.

That’s all for today. See you Thursday for the next issue.

✍️ Today’s email was brought to you by Josh Martin. Connect with me on LinkedIn.

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