👋 Hey, let’s get into it. In October 2025, Novartis agreed to pay $12 billion for Avidity Biosciences and its muscle-targeted RNA pipeline. Unfortunately, the biotech deal supermarket has a strict no-refunds policy.

One of the acquisition’s crown jewels, del-desiran, has now missed the primary endpoint in a Phase 3 trial for myotonic dystrophy type 1, an inherited disorder that causes progressive muscle weakness and difficulty relaxing muscles after they contract. Investors responded accordingly, sending Novartis shares down roughly 12% before the opening bell.

The miss came shortly after its cardiovascular drug pelacarsen also failed Phase 3. Those setbacks follow three deaths linked to the investigational CAR-T therapy rapcabtagene autoleucel, which forced Novartis to pause multiple immunology and neurology studies.

For a company in the business of treating life’s rough stretches, Novartis is having quite one of its own.

🏛️ FDA Makes Drug Center Leaders Permanent and Adds Its First Technology-and-AI Deputy
HHS removed a few “acting” labels from the FDA org chart, selecting Michael Davis to lead CDER and Karim Mikhail to lead CBER. Davis will oversee drug reviews, while Mikhail’s center covers biologics including vaccines and cell and gene therapies. HHS also selected Jared Seehafer as the FDA’s first deputy commissioner for technology and artificial intelligence. The new role signals that modernizing FDA systems has reached the executive suite, but it does not mean algorithms are about to approve drugs or rewrite evidence standards during lunch.

💉 Novo’s Semaglutide Moves 40% of Children Below the Obesity Threshold
Novo reported that 40.4% of children ages 6 to under 12 receiving weekly semaglutide plus lifestyle support moved below the obesity threshold after 68 weeks, versus none on placebo. Important fine print: that estimate assumed participants stayed on treatment, and crossing a BMI category is not the same as losing 40% of body weight. The 165-child Phase 3 trial met its primary BMI-reduction endpoint, but the full data and longer-term safety questions still matter before Novo can make its case for treating an even younger population.

🕰️ Insilico’s Lung Drug Lowers Predicted Biological Age
Insilico researchers ran blood-protein data from 42 participants in an earlier 12-week IPF trial of rentosertib through six proteomic aging clocks. The models generally assigned younger biological ages after treatment, an intriguing signal for an AI-discovered lung drug. But this was a small, exploratory reanalysis, not a rejuvenation trial. Changes in disease or inflammation could shift the protein patterns without slowing whole-body aging, and six models examining the same patients do not equal six independent studies. The blood test looks younger. The birth certificate remains unimpressed.

🫁 AstraZeneca’s Tozorakimab Cuts COPD Flare-Ups, Lands FDA Priority Review
AstraZeneca’s IL-33 antibody cut moderate or severe COPD flare-ups 29% and 34% versus placebo in the primary former-smoker populations of two Phase 3 trials. Similar reductions appeared when current smokers were included, suggesting tozorakimab may reach beyond the narrower patient groups targeted by some respiratory biologics. The FDA has accepted the application for priority review, with a decision expected in Q1 2027. AstraZeneca used a priority-review voucher to speed up the clock, however, so faster review should not be mistaken for an early FDA victory lap.

Stop hoping the algorithm finds your audience. They’re already here.

Put your brand in front of 1,600+ scientists, founders, investors, operators, and other biotech and pharma professionals.

Interested in sponsoring an upcoming issue? Reply to this email and let’s talk.

Alright, back to the newsletter.

🔐 Boston Scientific Says Cyberattack Will Likely Derail 2026 Guidance
Following its August cyberattack, Boston Scientific now says it will likely miss 2026 sales-growth and adjusted-earnings guidance.

☀️ Solstice Launches With $225M for Earlier-Stage Cancer Immunotherapy
Solstice Oncology launched with a $225 million Series A to test porustobart, a CTLA-4 antibody, plus Keytruda before surgery in earlier-stage, microsatellite-stable colon cancer.

🎯 Amgen’s Imdelltra Combo Scores First-Line Lung Cancer Survival Win
Imdelltra plus Imfinzi improved overall survival versus Imfinzi alone as first-line maintenance for extensive-stage small-cell lung cancer in Phase 3.

💊 Structure Shows Its Hand in the Obesity Race With GLP-1 and Amylin Data
Aleniglipron delivered up to 16.2% weight loss at 72 weeks, while Structure’s early oral amylin candidate showed promise…and plenty of nausea.

🧬 BMS’s CAR-T Clears a Pivotal Myeloma Endpoint
BMS’s GPRC5D-targeted CAR-T met overall and complete-response goals in a registrational Phase 2 myeloma trial that included patients previously treated with BCMA therapies.

💰 Google-Backed Encoded Raises $275M for Dravet Gene Therapy
Encoded raised $275 million to advance ETX101 for SCN1A-positive Dravet syndrome through pivotal development and expand its in-house genetic-medicine manufacturing.

🧪 Revvity Buys Into Human Beta-Cell Models With Acquisition
Revvity agreed to acquire Human Cell Design, adding human pancreatic beta-cell models for diabetes and obesity drug discovery. Financial terms stayed in the incubator.

💊 Beeline’s Lupus Pill Goes Three-for-Three in Phase 2
All three afimetoran doses beat placebo on a composite lupus-response measure in Phase 2, sending Beeline toward pivotal development.

China has become impossible to ignore in biotech dealmaking, but it’s not the only stamp showing up in the industry’s passport. A new BioSpace feature points to South Korea, Australia, Hong Kong, India and Canada as other places attracting attention. The useful takeaway is not that biotech is packing up and leaving China. It’s that different locations solve different problems.

South Korea brings an established biotech base, clinical infrastructure and major biologics players. Australia has built a reputation for running early clinical trials, supported by formal notification and approval pathways for studies involving unapproved medicines. One offers a mature industry ecosystem. The other can offer a practical place to generate clinical evidence. Neither is an automatic shortcut to success elsewhere.

Hong Kong plays a different role. Its Chapter 18A listing route, launched in 2018, allows qualifying pre-revenue biotechs to access public markets. That makes it a financing gateway, particularly for China-linked companies, not a way to remove China from the equation.

India is the longer-term bet. The country already has enormous pharmaceutical scale, but building an original-drug ecosystem beyond its generics foundation will take time. Canada, meanwhile, offers another regulated environment for clinical development, complete with Health Canada authorization and good-clinical-practice requirements.

The broader lesson is that “international expansion” is too vague to be useful. Is a company searching for an asset, trial infrastructure, manufacturing capacity or capital? Those are four different itineraries. Biotech’s next global hubs will not necessarily replace one another. They may simply handle different legs of the journey. Either way, business development is earning its frequent-flyer miles.

This is the number of biosimilars Sandoz wants in its portfolio by 2040, up from 13 marketed today. It’s backing that patent-cliff shopping list with a $300 million drug-substance facility in Slovenia. Ambitious, yes. But 2040 gives the calendar plenty of breathing room.

Here’s what biotech Redditors are talking about:

📜 How Long Can the GLP-1 Indication List Get?
GLP-1s are collecting proposed indications like LinkedIn endorsements. Redditors discussed everything from alcohol use and knee pain to possible anti-inflammatory effects, alongside the familiar frustration of losing insurance coverage for the drugs. The excitement is understandable, but approved uses, clinical hypotheses and personal anecdotes are not interchangeable. The indication list may keep growing, but the evidence still has to grow with it. Science remains the bouncer.

🛒 Is Anthropic Going Biotech Shopping?
After an Anthropic job posting sought someone to execute life-sciences acquisitions, Redditors speculated the AI giant may be preparing for a biotech shopping spree. The discussion quickly shifted to AI’s role in drug discovery. Some saw potential to accelerate research, while others said the real bottlenecks remain data, lab experiments and clinical translation. Skeptics saw a simpler playbook: buy a few biotechs, sell investors a story about AI curing cancer and extending life, then ride the funding hype. Want to see the job posting that started it all? Keep scrolling to BioBits.

🤑 Anthropic Offers Up to $600K for a Life-Sciences Dealmaker
Anthropic listed a San Francisco life-sciences dealmaking role paying $425,000 to $600,000 annually. The compensation is senior-level salary, not the sector’s new baseline.

🎬 Elizabeth Holmes Returns to the Big Screen
A new A24 documentary follows Elizabeth Holmes before prison, with Nathan Fielder and Lance Oppenheim directing. Apparently, Theranos still has content in the pipeline.

🔬 AI Reads Antibiotic Mechanisms From Ordinary Microscope Images
Researchers trained AI to classify antibiotic mechanisms from ordinary brightfield microscope images, creating a promising laboratory-screening tool.

🧠 BrainChild Takes CAR-T Into One of Childhood Cancer’s Toughest Targets
CAR-T has transformed blood cancers. BrainChild wants to see whether it can do something similar in one of the hardest solid tumors: DIPG, an aggressive pediatric brain cancer with few treatment options. The startup raised $116 million and started a Phase 2 trial of BCB-276, delivered directly into cerebrospinal fluid every two weeks after radiation. Patients can receive up to 15 doses across six sites, with overall survival as the primary endpoint. The trial could support registration, but first it must show whether the approach can extend life.

🧬 September 10, 1984: A Lab Surprise Creates DNA Fingerprinting
Most Monday morning lab surprises mean someone mislabeled a tube or forgot to put something back in the freezer before leaving Friday. On Monday, September 10, 1984, Alec Jeffreys looked at puzzling DNA patterns from his technician and her parents and realized they could do two things at once: identify a person and reveal family relationships. That flash of insight became DNA fingerprinting. The technique would go on to reshape paternity and immigration cases, and eventually forensic investigations. One confusing result, one very productive Monday.

Forty-two years ago, Alec Jeffreys looked at a complicated lab result and saw a new way to identify people. Most confusing results still mean rerunning the experiment and apologizing to your PI. His result launched an entire field.

So if today’s data look strange, congratulations: you may be making history…Or you used the wrong buffer. Either way, write it down.

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

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

If you’re enjoying BioNucleus, share it with a friend or coworker who’d get value from it. We’re a small operation, and every share makes a bigger difference than you think.

Was this email forwarded to you? Sign up here 👇

Subscribe for free

Follow us on social and stay one step ahead