👋 Hey, let’s get into it. Viking Therapeutics has a proposal for anyone whose calendar is already full: What if a weekly weight-loss shot became a monthly appointment?

Its experimental GLP-1/GIP drug, VK2735, helped participants lose roughly 16% to 19% of their body weight during 21 weeks of weekly injections. They then tested less frequent maintenance doses. The best monthly group retained 90% of that loss over the next 12 weeks; monthly groups overall retained 85%, versus 61% for those switched to placebo. The results are still early, but they were enough to send Viking shares up nearly 36%.

“This meeting could have been monthly” may finally be useful clinical-trial feedback.

🇪🇺 Nine Pharma Chairs Warn Europe Is Losing the Drug-Investment Race
The chairs of AstraZeneca, Boehringer Ingelheim, Chiesi, Ipsen, GSK, Novo, Novartis, Roche, and Sanofi have co-signed a warning to European leaders. Their letter says Europe’s share of global pharmaceutical R&D fell from 43% in 1990 to 31%, while its share of commercial clinical trials has dropped to 9%. They want faster trials, stronger intellectual-property protections, workable digital rules, and changes to national health funding and reimbursement. Nine pharma chairs agreeing on one letter is quite a group project. Getting governments to act is the harder assignment.

🧬 Envisagenics Signs Potential $1B-Plus Cancer Deal With Boehringer
Boehringer Ingelheim is teaming up with Envisagenics to hunt for cancer targets created by alternative RNA splicing, the process that lets cells assemble different messages from the same gene. The companies will look for tumor-associated proteins that could be attacked with antibody-drug conjugates, T-cell engagers, or other antibody-based treatments. Upfront, research, option, and milestone payments could exceed $1 billion, with royalties on top; the upfront amount was not disclosed. The appeal is a more selective target. The hard part is proving these newly identified targets distinguish tumors from healthy tissue well enough to make useful medicines.

☢️ Novartis Licenses Preclinical Radioligand Drug in Deal Worth Up to $900M
Novartis secured global rights to a preclinical radioligand therapy from BoomRay, in a deal worth up to $900 million in upfront and milestone payments, plus royalties. These therapies pair a targeting molecule with a radioactive payload, aiming to deliver radiation to cells carrying a particular marker. Novartis has disclosed neither this asset’s target nor its upfront payment. That leaves a fairly clear business story and a much less clear scientific one. Radiopharma dealmaking is busy, as readers saw with Telix’s ITM acquisition Tuesday. Whether this particular candidate earns a place in the clinic remains to be seen.

🏛️ Senators Oppose Reported Plan for Political Review of NIH Grants
A reported White House proposal to add political review to NIH grant awards is already meeting resistance on Capitol Hill. One structure under discussion would require agreement from a board that includes NIH Director Jay Bhattacharya and budget director Russell Vought before funding could proceed. Senators Susan Collins and Patty Murray objected; Collins said involving the Office of Management and Budget in award decisions would conflict with congressional intent and pointed to restrictions in a recently enacted funding measure. The concern is what happens after scientific review selects an award. The proposal’s final form, and whether an order will be issued, remain unresolved.

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🧠 Lilly Explores a GLP-1/GIP Drug for Depression and Alcohol Use Disorder
Lilly presented early brenipatide safety data last week. Separate Phase 3 trials are testing depression and alcohol use disorder.

🤖 Nvidia-Backed Iambic Files for IPO and Partners With AbbVie
Iambic filed for a U.S. IPO and announced an AI-assisted drug-discovery partnership with AbbVie; the offering has not yet been priced.

🧬 Ionis and Otsuka Win Phase 3 FUS-ALS Trial
The antisense drug, Ulefnersen, met its pivotal endpoint in genetically defined FUS-associated ALS; the companies plan regulatory discussions, with fuller results still needed.

💼 Bayer Agrees to Sell Cancer Drug to Grünenthal for Up to €375M
Grünenthal agreed to acquire Bayer’s marketed cancer medicine Stivarga in a transaction worth up to €375 million ($427M).

📉 Roche’s GLP-1/GIP Drug Delivers 15.5% Weight Loss in Diabetes
In a Phase 2 trial involving people with type 2 diabetes, the highest enicepatide dose produced 15.5% mean weight loss at 48 weeks.

🧠 J&J’s Caplyta Wins a Phase 3 Bipolar-Mania Trial
Caplyta beat placebo on manic symptoms in a pivotal bipolar I study; a second study’s results were still being analyzed.

❤️ Boehringer Expands Variant Bio Deal Into Cardiovascular Disease
Boehringer added cardiovascular target discovery to its Variant Bio collaboration, with an undisclosed upfront payment and potential value exceeding $250 million.

⚠️ Celldex’s Phase 3 Hives Wins Come With Safety Questions
Barzolvolimab met endpoints in two chronic-hives trials, but the pooled safety presentation reported two probable severe anaphylaxis cases after active treatment.

I know what you’re thinking: One blood draw to screen for more than 50 cancers? Is this the debut of Theranos 2.0? No. It’s Grail’s Galleri test, and on Wednesday an FDA advisory panel backed its proposed use in adults 50 and older. If the FDA agrees, Galleri could become the first approved blood test designed to screen for multiple cancers at once.

The vote was more complicated than a simple thumbs-up. All 10 panelists agreed Galleri was safe. But when asked whether it was effective, they split 6–4. Seven said its benefits outweighed its risks, two disagreed, and one abstained. The panel’s advice carries weight, but the FDA still makes the approval decision.

Galleri searches blood for cancer-associated patterns on DNA fragments and predicts where a detected signal may have come from. That could be especially useful for cancers without routine screening. But how often does the test find one?

In the newly published PATHFINDER 2 study, about six in ten positive results corresponded to cancer. The test detected 39.3% of cancers diagnosed during the study’s 12-month observation period. Those figures describe an earlier version of the test, and they answer different questions: how much to trust a positive result and how many cancers the test catches.

The bigger question is whether adding Galleri to routine care leads to better outcomes. The randomized NHS-Galleri trial missed its primary goal of reducing combined stage III and IV cancer diagnoses across 12 selected cancers. A positive Galleri result still needs diagnostic follow-up; a negative one does not replace a mammogram or colonoscopy.

Grail got its panel win. Now the FDA must decide whether the evidence supports approval, while researchers continue asking whether finding more cancer signals means fewer advanced cancers and deaths.

This is the percent of new Medicare GLP-1 patients taking Lilly medicines, according to CEO David Ricks. He said roughly 700,000 seniors had started treatment following the coverage expansion.

Here’s what biotech Redditors are talking about:

🌎 Just Some Small Talk: What’s the Future of American Biotech?
A Redditor tossed out a casual little question: What’s the future of biotech in America? The replies were less casual. Some commenters saw more layoffs and tighter hiring ahead. Others expected companies to keep smaller research teams and outsource more experiments, especially as China invests in drug development. Nobody was debating this from a comfortable distance; these are the kinds of questions people ask when they’re trying to picture their next job and what their career looks like over the long haul.

🧪 Wolverine Peptide, Show Your Work
Redditors are debating BPC-157, the “Wolverine” peptide being pitched for healing despite having little human evidence behind it. Case in point, as one commenter observed: Some anti-vaxxers will gladly try a peptide we know little about while treating FDA-approved vaccine evidence with suspicion. Others admitted they understand the temptation when you’re injured and want something to help. Fair enough. But a superhero nickname and a confident website can’t tell you whether it works. That takes a study, preferably more than one.

📉 Novo’s Headcount Falls 13,000
Over the past year, Novo’s workforce fell by about 13,000, including 9,000 previously announced layoffs; the remaining 4,000 included attrition and retirements.

🛡️ Flagship Lands Department of War Deal Worth Up to $47M
Flagship Pioneering won a five-year contract to develop medical countermeasures, starting with research projects involving two of its portfolio companies.

🌍 Anthropic and OpenEvidence Plan Free Medical AI for Doctors
The companies plan free clinical-information AI access for physicians in about 100 low and middle income countries, adapted to local treatment options.

🐭 FDA Rewrites the Animal-Testing Rulebook
The FDA replaced animal-specific wording with broader nonclinical language, giving developers room to use alternative methods without banning animal studies.

🌳 Enveda Raises $311M to Turn Nature’s Chemistry Into Medicines
Enveda closed a $311 million Series E to advance medicines discovered by searching nature’s vast chemical library. Its PRISM platform combines AI with lab work to identify promising molecules, then the usual difficult work of developing a drug begins. The company now has three programs in human trials, including candidates for inflammatory disease and metabolic health. It has raised more than $845 million in total. Nature supplied the chemical library. Now Enveda has to show which discoveries deserve a spot in the medicine cabinet.

🧬 September 24, 1905: The Scientist Who Helped Take RNA Outside the Cell Is Born
On this day in 1905, Severo Ochoa was born in Spain. Fifty years later, he and collaborators including Marianne Grunberg-Manago showed that an enzyme could assemble RNA-like chains outside living cells. That gave scientists another way to make and study nucleic acids without asking a cell to do all the work. Ochoa shared the 1959 Nobel Prize with Arthur Kornberg for research on nucleic-acid synthesis. Before RNA became biotech’s favorite three-letter celebrity, researchers had to figure out how to work with the stuff on the bench.

Thinking back to the Community Vibes debate about the future of American biotech, at least we’ve found a new answer to the dreaded interview question: “Where do you see yourself in five years?”

Usually, you have to say something about growing into a leadership role. Now you can look the interviewer dead in the eye and confidently say, “Probably at a lab in China.”

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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