👋 Hey, let’s get into it. GLP-1s can curb your appetite and help you lose weight. And there may be a tiny chance you lose something else…your vision.

The FDA is requiring a warning about NAION, a rare condition that can cause sudden, sometimes permanent vision loss in one eye. Across 126 trials, there were 6.4 cases per 100,000 person-years on GLP-1s versus 3.8 on placebo or other glucose-lowering drugs.

If your vision suddenly changes in one eye, call your doctor right away. If you’ve been squinting at our font since day one, that one’s on me.

👍 FDA Approves Bayer’s Stroke Prevention Drug
Bayer’s Sunharbo is the first FDA-approved drug to block factor XIa, a protein that helps clots grow. It’s approved alongside antiplatelet therapy for adults after a recent mild-to-moderate ischemic stroke from a clot that formed outside the heart or after a high-risk transient ischemic attack. In a trial of more than 12,000 people, ischemic strokes occurred in 6.2% on Sunharbo versus 8.4% on placebo, both alongside antiplatelet therapy. Major bleeding rates were similar overall, but major bleeds were more common with Sunharbo in patients over 75 and during the first 90 days.

📈 PepGen Shares Jump 163% on Muscular Dystrophy Drug Data
In myotonic dystrophy type 1, faulty RNA disrupts splicing, the process cells use to stitch together pieces of an RNA message. In a Phase 2 cohort, PepGen reported 46.5% average splicing correction across a panel of muscle RNA markers in six treated participants. By week 16, hand-opening time improved by 3.9 seconds with the drug and 0.2 seconds with placebo. The data sent shares soaring 163% in early trading Tuesday. The results give PepGen a reason to keep going, with six treated patients and four months of follow-up leaving plenty to learn about lasting benefit.

💉 AstraZeneca Acquires Omniose’s Bacterial Vaccine Platform
AstraZeneca was in Tuesday’s opener over a rumored bid for Rhythm. Today it’s back with a completed deal for Omniose, its vaccine research partner. Conjugate vaccines attach sugars from a bacterium’s surface to a carrier protein so the immune system mounts a stronger response. Omniose’s platform could simplify that manufacturing step, giving AstraZeneca a tool it can use across multiple bacterial vaccine programs. Those programs are still preclinical, and the purchase price is undisclosed. After three years of working together, AstraZeneca finally put a ring on it.

🩸 Beam’s Base-Edited Sickle Cell Therapy Hits Its Goal
Beam says risto-cel met its pivotal goal of keeping patients free of severe sickle cell crises for at least 12 consecutive months. The therapy edits a patient’s own blood stem cells to make more fetal hemoglobin, which helps keep red blood cells from sickling. Patients still need chemotherapy to prepare for the stem cell transplant. Beam could file with the FDA by year-end, putting base editing on the doorstep of its first U.S. application.

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🎟️ BioNTech Agrees to Buy a $205 Million FDA Review Voucher
BioNTech agreed to buy the voucher from Scholar Rock to shorten FDA review of a future oncology filing and is keeping the drug under wraps.

📉 ImmunityBio Shares Fall 20% Despite Phase 3 Bladder Cancer Win
Anktiva plus BCG met its goal in patients starting BCG for high-grade non-muscle-invasive bladder cancer, while quarterly revenue fell short of Wall Street expectations.

❤️ Boehringer’s Obesity Drug Meets Its Phase 3 Heart Safety Goal
Survodutide met its prespecified cardiovascular safety threshold versus placebo in a Phase 3 trial of 5,530 adults with elevated cardiovascular risk.

🤝 MaxCyte Agrees to Buy Akron Bio for $151.8 Million
The deal would add manufacturing-grade reagents to MaxCyte’s cell engineering business, giving cell therapy developers another reason to call the same supplier.

🇨🇳 Pentagon Removes WuXi AppTec From Its Chinese Military Company List
The Pentagon removed the research and manufacturing supplier from its Section 1260H list following an August court order, with possible relisting on new grounds.

🍺 Altimmune Sets December FDA Meeting for Its Alcohol Use Disorder Drug
In Phase 2, 42.2% on pemvidutide reported zero heavy-drinking days in the trial’s final four weeks, versus 17.4% of participants who received placebo.

📉 Legend Shares Fall 16% as CAR-T Sales Expectations Cool
Legend said Wall Street’s 2027 Carvykti sales estimates were already near its high end, citing overseas launch delays and slower U.S. uptake earlier in treatment.

✅ FDA Approves Merck KGaA’s Drug for a Rare Joint Tumor
The FDA approved pimicotinib for adults with symptomatic tenosynovial giant cell tumor when surgery could impair function or cause serious complications.

If you want to catch the competition off guard, posting the whole plan online is an interesting first move. On Tuesday, biotech trade group BIO did exactly that. It’s called BioAdvance, and it’s a seven-point pitch to keep the U.S. competitive as China gains ground in early clinical trials.

Start with the paperwork. BIO wants a permanent White House biotech office to coordinate policy across agencies. It also wants to get drugs into first-in-human studies sooner by centralizing how trial sites get approved and contracts get signed. If you’re running a small biotech, every month a site spends waiting on paperwork is another month of payroll before you can dose your first patient.

The plan also calls for making it easier for patients to join trials, giving researchers more predictable federal funding, and training more people to manufacture drugs in the U.S. BIO wants targeted tax incentives and changes to intellectual property policy, too, to help young biotechs raise money and grow here.

Then there’s Treasury’s proposed COINS rule, which would restrict certain U.S. investments in Chinese biotech on national security grounds. A straightforward license with cash payments, milestones, and royalties would generally fall outside those limits. Offer your partner equity or agree to develop the drug together, and deal lawyers say things get murkier. Investor RA Capital argues that uncertainty could give an edge to buyers that can afford to pay cash and foreign competitors with more flexibility.

BIO wants more companies to run their first trial here, but it would help if those companies knew whether they could sign the deal that gets them the drug in the first place.

That’s the share of assessed late-stage drug candidates with access plans in the 2026 Access to Medicine Index. The index tracks 20 large pharma companies, and that share has more than tripled since 2018. For patients, the test is whether medicines are available and affordable after approval.

Here’s what biotech Redditors are talking about:

🥼 Is the U.S. Driving Away Young Scientists?
A New York Times story on federal research cuts and the young scientists rethinking their careers got r/biotech talking about how early the squeeze starts. One commenter said students in their department were leaving with master’s degrees after failing to match with a lab, while postdocs were losing jobs or waiting on grants. Another described applying for industry roles they felt qualified for and getting zero callbacks. It’s a brutal time to be starting out. Federal research cuts are squeezing academia, and biotech is still feeling the post-COVID hiring slump.

📚 Biotech Reddit Builds a Reading List. What’s on Yours?
A biotech undergrad was about to buy Bad Blood to learn about Theranos and asked Reddit what else to read. Recommendations included The Emperor of All Maladies and The Hot Zone, which one reader credited with getting them interested in viruses. Another liked The Breakthrough for explaining cancer immunotherapy to family. What’s your favorite biotech or science book? Reply to this email. If enough people respond, we’ll share a reader-built list in a future issue.

💍 Oura Agrees to Buy Counsel Health for $625 Million
Oura wants to connect the data from its smart ring with Counsel Health’s AI-assisted care platform, where users can also reach human physicians.

🩸 Blood RNA Marker May Help Detect Ovarian Cancer Early
Researchers found an RNA signal in blood that helped identify people with fallopian tube lesions that can develop into an aggressive form of ovarian cancer.

💊 Veradermics’ Hair Loss Pill Shows Sustained Growth at 12 Months
Men taking Veradermics’ experimental oral minoxidil maintained hair gains at one year, with the original placebo group switching to active treatment after six months. Sweet gains, bro.

😬 U.S. Measles Outbreaks Cost an Estimated $37 Million in 2025
CNBC reported that Johns Hopkins put the total above $37 million, counting public health response and lost productivity alongside direct medical costs. If only a vaccine existed…

🧠 Delix Raises $100 Million for a Depression Drug Designed to Avoid Hallucinations
Delix raised a $100 million Series C co-led by Johnson & Johnson Innovation–JJDC and SV Health Investors’ Dementia Discovery Fund. Its oral drug, zalsupindole, takes inspiration from psychedelics and is designed to help the brain form and remodel connections without causing hallucinations. Delix expects to start a placebo-controlled Phase 2 trial in recurrent major depression in the first half of 2027. If the drug works as intended, it could make treatment easier to deliver without the logistics of a supervised psychedelic session. As for getting your chatbot to stop hallucinating…that program never made it to Phase 1.

📖 November 12, 1968: A Biology Teacher Helps Overturn Arkansas’s Evolution Ban
When Little Rock biology teacher Susan Epperson got a new textbook, it came with a problem. The book covered human evolution, and Arkansas law barred her from teaching it. Epperson challenged the law, and on November 12, 1968, the U.S. Supreme Court struck it down. The justices held that the state couldn’t tailor public school science lessons to a religious doctrine under the First Amendment. Every life science career starts somewhere. For plenty of us, it was a high school biology class with that chapter in it.

All this talk about GLP-1 warnings has me thinking about drug commercials. My favorite part is when the narrator tells you to avoid the drug if you’re allergic to it while an older couple smiles awkwardly through a game of pickleball.

Disclaimer: Side effects of BioNucleus Briefing may include bringing up drug approvals at brunch, excessive sweating during pharma earnings calls, and a sudden urge to shout “Novo just did what?” across the office.

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

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