👋 Hey, let’s get into it. uniQure called its latest Huntington’s gene-therapy data “encouraging.” Wall Street also felt encouraged...to sell the stock, sending shares down around 37% on Tuesday.

AMT-130, its lead gene therapy, aims to slow Huntington’s disease progression. At four years, it showed 44% slower decline on a composite disease scale, but missed statistical significance. A separate everyday-function measure fared better, showing 61% slowing with nominal significance. The analysis involved just 12 high-dose patients compared with external controls.

uniQure’s FDA application remains pending, but investors clearly don’t want to wait around.

💉 Lilly Details 20.8% Weight Loss With Triple-Action GLP-1 Retatrutide
Newly detailed Phase 3 results give Lilly’s retatrutide more to discuss than its previously announced weight-loss headline. In 1,152 adults with type 2 diabetes and overweight or obesity, the triple-action GLP-1/GIP/glucagon drug produced 20.8% mean weight loss at 12 mg over 80 weeks, versus 4.0% with placebo, in the efficacy analysis. At that dose, 59.5% fell below the BMI threshold for obesity and A1C dropped 1.5 percentage points. Then there’s tolerability: 28% reported nausea, versus 8% on placebo. Lilly plans a Q1 2027 U.S. submission.

💰 AstraZeneca Invests $2B in Summit for Cancer-Drug Combos
AstraZeneca agreed to invest $2 billion in Summit, buying roughly 12% of the company and teaming up on cancer-drug combinations. First up: ivonescimab, which blocks an immune checkpoint and tumor blood-vessel signaling, paired with AstraZeneca’s Sone-Ve, an antibody-drug conjugate targeting CLDN18.2, in gastrointestinal cancers. Both companies will contribute to trial costs and keep rights to their own medicines; additional combinations remain an intended expansion. That’s a $2 billion way of asking, “Want to run an experiment together?” It gives Summit substantial backing, while the drug combos still have to prove themselves in patients.

🫣 Beam Therapeutics Sues Over Alleged Gene-Editing Trade Secret Theft
Beam sued YolTech and Serapha Bio, alleging a former employee used confidential information to help develop a rival gene-editing program. At the center of the dispute are Beam’s BEAM-302 and SERP-01, which Serapha licensed from YolTech. Both are being developed for alpha-1 antitrypsin deficiency, a genetic condition that can damage the lungs and liver. Serapha denies the allegations, and YolTech’s CEO also rejects them. At the moment, no court finding establishes theft or requires a clinical halt. For biotech dealmakers, the case highlights why diligence has to examine where an asset’s technology came from alongside what its clinical data show.

💊 Novo Pays Up to $2.6B for Hengrui’s Weekly GLP-1 Pill
Novo Nordisk wants to simplify your pill box. It agreed to license Hengrui’s HRS-1596, a GLP-1/GIP candidate designed for potential once-weekly oral dosing, for $300 million upfront. Payments could reach $2.6 billion if milestones are met, plus royalties. Novo gets rights outside mainland China, Hong Kong, Macao, and Taiwan, with closing expected in Q4. The catch? HRS-1596 is only Phase 1-ready, so human efficacy and a workable weekly regimen remain unproven. After last week’s Nanexa injection-delivery deal, Novo is placing yet another bet on making treatment less frequent.

🏭 BioNTech Plans German Site Closures After Buyer Search Fails
BioNTech’s search for buyers for three German manufacturing sites failed, leaving staged closures planned through 2028, along with up to 1,800 jobs impacted as it shifts resources toward oncology.

🧪 Adicet’s Off-the-Shelf CAR-T Shows Early Lupus Remissions
Adicet reported early lupus remissions with donor-derived prula-cel in a small, uncontrolled Phase 1 study, with pivotal-study preparations planned for Q4.

💉 Zealand’s Amylin Drug Petrelintide Shows 10.7% Weight Loss
Detailed Phase 2 results showed Zealand and Roche’s investigational amylin drug produced 10.7% mean weight loss at 42 weeks versus 1.7% with placebo, along with high tolerability.

🦠 Mirum’s Hepatitis Delta Antibody Meets Phase 3 Goal
Mirum’s antibody (brelovitug) achieved combined viral response and liver-enzyme normalization in 56% of weekly-dose patients versus 0% with delayed treatment at 24 weeks.

🇺🇸 White House Looks for Room to Bring 86 Essential Medicines Home
The White House is asking manufacturers about available capacity to support essential medicine reshoring. Responses are due October 26, with no purchasing commitment at this time.

👎 Roche Drops Muscle-Sparing Obesity Candidate
Roche ended emugrobart’s obesity development after interim Phase 2 data suggested insufficient weight-loss efficacy, returning rights to Chugai.

Washington’s 100% pharma tariff comes with enough exceptions to make “it depends” an official customs category. The framework expanded to its remaining company cohort on September 29. Now comes everyone’s favorite part of drug development…interpreting customs paperwork.

The baseline rate applies to covered patented medicines and associated ingredients. Generics, biosimilars, and their ingredients currently sit outside this action. For covered products from the EU, Japan, South Korea, and Switzerland/Liechtenstein, the rate is 15% unless a lower provision applies. Your company’s headquarters alone won’t tell you what its shipment owes.

Qualifying onshoring plans can bring the rate to 20%, scheduled to rise to 100% in April 2030. Eligible companies with both onshoring and most-favored-nation pricing arrangements can receive zero duty through January 20, 2029. A factory announcement by itself doesn’t unlock the discount; eligibility requires an administrative determination.

Then come the specialty exceptions. Commerce’s September 23 guidance spells out zero-duty eligibility for categories including cell and gene therapies, antibody-drug conjugates, nuclear medicines, and certain orphan drugs. Products must meet the eligible-origin condition or receive approval based on an urgent U.S. health need. For the orphan category, all approved indications must qualify. Simply arriving at customs with an ADC won’t do it. The guidance also adds zero-duty treatment for qualifying imports solely intended for clinical trials, research, or other noncommercial uses.

For developers and manufacturing partners, the job is mapping products, sourcing, and agreements before assuming a rate. Zero duty under this measure doesn’t erase every possible levy, and a 100% import tariff doesn’t automatically double a patient’s pharmacy bill.

The asterisk may be the most valuable ingredient in this supply chain.

This is the percent of body weight lost, on average, by 194 adults who switched from injections to Novo Nordisk’s daily Wegovy pill and stayed on it for three months. Loss was measured from the switch. These are observational data, not a head-to-head comparison with injections.

Here’s what biotech Redditors are talking about:

📩 Your Layoff Is in Another Conference Room
Redditors traded stories about their worst layoff experiences, including being assigned to one of two conference rooms, finding a mysterious envelope at their desk, or discovering their badge stopped working before anyone explained why. Losing a job is hard enough without having to decode the meeting invitation. To our subscribers in the C-suite: Maybe try more of a straight-forward conversation approach and less of a corporate Squid Games approach.

🧫 CAR-T Workers Ask Whether the Chaos Comes With the Cells
Redditors working in CAR-T discussed constant firefighting, overflowing messages, and timelines that seem to assume living cells read project plans. Some described the added complexity of making individual patients’ batches, while others pushed back on the idea that every team operates in chaos. Several still found the patient impact deeply rewarding. The work can be worth doing while the schedule needs work. The cells, unfortunately, have declined your calendar invitation.

🧪 Bruker Expands Functional-Proteomics Workflows
Bruker introduced research workflows to study protein structure, modifications, and molecular variation, extending analysis beyond identifying which proteins are present.

🏛️ Former House Majority Leader Eric Cantor Will Lead PhRMA
Former House majority leader Eric Cantor will become PhRMA’s president and CEO on November 9, succeeding Steve Ubl amid pricing and manufacturing policy debates.

🧬 10x Ships Atera and Introduces Sentira Analysis Software
10x Genomics began shipping its Atera spatial-biology platform and introduced Sentira Spatial analysis software in free early access, with paid launch expected in 2027.

🎯 ai3Bio Launches With $48M to Target Autoimmune T Cells
ai3Bio launched with a $48 million Series A led by UPMC Enterprises and Ziff Capital Partners to selectively remove disease-driving Th17 cells. The startup combines technology from Corner Therapeutics and Novasenta, with approaches using mRNA delivered in lipid nanoparticles or antibodies that recruit immune clearance. The goal is to eliminate troublesome cells while preserving normal immune function. Think a more selective unsubscribe button for inflammatory signaling. That precision is still an ambition though: evidence so far is preclinical, and the financing supports development toward human studies.

🧬 October 1, 1990: The Human Genome Project Starts Reading the Instructions
On this day in 1990, the Human Genome Project officially began, launching an international effort to map and sequence human DNA. The NIH and Department of Energy led the U.S. work. The project also tackled data sharing and genetic ethics. It reached completion in 2003, producing a reference sequence that still contained gaps. Thirty-six years after launch, that foundation runs through modern diagnostics, drug discovery, and the gene-therapy programs making today’s headlines. Reading the instructions turned out to create plenty of new questions…which is why I never read them. 🙃

Thinking back to the CAR-T thread in community vibes, I’d love to sit in on the project meeting where someone finally asks the cells whether the deadline works for them.

“Can we pull delivery forward two weeks?”

The cells continue dividing at their usual pace.

“Great. I’ll mark that as aligned.”

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.

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