👋 Good morning! Novo Nordisk wanted a comeback moment. Instead, it got a reminder of who currently runs the obesity market.

In a highly anticipated head-to-head Phase 3 study, Novo’s GLP-1 and amylin combo CagriSema failed to beat Eli Lilly’s Zepbound. Over 84 weeks, patients on CagriSema lost 23% of body weight. Zepbound delivered 25.5%. In obesity, 2.5 percentage points is not rounding error. It is market share.

Novo’s Chief Scientific Officer said the company was “pleased” with 23% weight loss. Investors were less pleased. Shares dropped 15% in premarket trading while Lilly ticked up 3.5%.

This one stings. Novo already filed CagriSema for FDA approval and recently showed it outperformed Wegovy in diabetes patients. But the goal was not to beat Wegovy. The goal was to reclaim the crown from Lilly.

Mission failed.

💰 Gilead Drops $7.8B to Lock In Its CAR-T Contender
Gilead is buying Arcellx for $7.8 billion to take full control of BCMA-directed CAR-T therapy anito-cel, which is under FDA review for relapsed or refractory multiple myeloma. The $115 per share cash offer represents a 68% premium to Arcellx’s 30-day average, with another $5 per share tied to hitting $6 billion in cumulative sales by 2029. Gilead already owned 11.5% and was on the hook for $530 million in milestones. Rather than keep writing checks, it bought the whole thing. With a Dec. 23 PDUFA date, this is a pre-approval power move.

🖖 Merck Splits the House Before the Keytruda Cliff
Merck is reorganizing its human health business into two units: a standalone oncology division and a separate specialty, pharma and infectious diseases group. The timing is not subtle. Keytruda generated $31.7 billion last year and is projected to peak at $35 billion in 2028, the same year U.S. exclusivity is expected to end. More than half of Merck’s $58.1 billion pharma revenue currently rides on that one drug. Translation: sharpen the oncology focus while building the post-Keytruda bench.

⚖️ Another CDC Shake-Up
Ralph Abraham, a vaccine skeptic and former Louisiana surgeon general, stepped down as CDC Principal Deputy Director after just three months, citing “unforeseen family obligations.” His departure follows last week’s exit of acting CDC Director Jim O’Neill. NIH Director Jay Bhattacharya has now assumed CDC leadership on an acting basis. The revolving door at federal health agencies continues to spin.

💉 Lilly Puts Zepbound on the Self-Pay Menu
About a month after securing FDA approval for a multidose KwikPen version of Zepbound, Lilly is rolling it out through its direct-to-consumer platform, LillyDirect. The one-month pen starts at $299 for the lowest dose and reduces the number of devices patients use from four to one. Zepbound generated $4.2 billion in U.S. revenue in Q4 alone, up 122% year over year. Convenience plus cash pay access equals fuel on an already raging fire.

1️⃣ FDA Ends the Two-Trial Dogma. Commissioner Marty Makary and CBER’s Vinay Prasad announced that one high-quality pivotal trial will now generally be sufficient for new drug approvals.

📈 Generate:Biomedicines Targets $425M IPO. The Flagship-backed biotech plans to price 25 million shares between $15 and $17 to fund Phase 3 asthma trials.

💰 Insmed Calls Its Shot at $1B. CEO Will Lewis defended an “audacious” projection that newly approved Brinsupri will hit $1 billion in 2026 sales after a $145 million Q4 launch.

🎟️ Fortress Sells PRV for $205M. Fortress subsidiary, Cyprium Therapeutics, flipped its rare pediatric disease priority review voucher just weeks after Zycubo’s approval, proving the PRV market is still hot.

⚔️ Bayer Sues J&J Over Prostate Claims. Bayer alleges Johnson & Johnson launched a false advertising campaign touting Erleada over rival Nubeqa.

🧠 GSK Partners With The Jackson Laboratory on Alzheimer’s Models. A five-year collaboration aims to build better human stem cell models for neurodegenerative drug discovery.

🏭 Bora Renews $250M GSK Manufacturing Pact. The five-year deal covers more than 20 product lines and 335 products across multiple therapeutic areas.

Last year, a critically ill baby named KJ received a custom CRISPR therapy designed specifically for his mutation. It worked. Now the FDA wants to make sure that kind of story is not a one-off miracle.

The agency has released draft guidance for a new approval pathway called the “plausible mechanism” framework. The idea is simple but radical. If the biology is clear and the therapy directly targets the underlying genetic cause, sponsors may not need massive trials to prove benefit. In ultra-rare disease, that could mean data from just a handful of patients, supported by natural history studies and validated biomarkers.

There are guardrails. Developers must show a defined biological cause, demonstrate that the therapy hits the intended molecular target, and design trials that show real clinical benefit such as symptom improvement or slowed progression. Biomarkers can support approval if they reliably predict outcomes. And post-market data collection will not be optional. If safety or efficacy disappoints, the FDA says it will pull the plug.

This is not a free pass. Regulators insist the evidentiary bar remains high. But the signal is unmistakable. The agency is trying to remove structural barriers that make individualized therapies economically impossible. When a disease has 100 mutations, regulators do not want 100 separate clinical trials.

There is also a geopolitical subtext. China has been aggressively streamlining its gene therapy and genome editing regulations. U.S. officials have openly acknowledged the risk of ceding early innovation abroad. The plausible mechanism framework is as much about competitiveness as compassion.

If it works, bespoke gene editing could evolve from heroic exception to scalable platform. If it falters, critics will say the FDA promised speed without clarity. Either way, the era of one-size-fits-all drug development is cracking.

That is how much Grail’s stock cratered after the NHS-Galleri trial failed to show a statistically significant reduction in late-stage cancers, missing its primary endpoint. The company highlighted improved early-stage detection, but investors zeroed in on what did not happen. In multi-cancer early detection, promise is plentiful. Proof is harder.

Here’s what biotech Redditors are talking about:

😵 Is this normal for big pharma?
One Redditor who jumped from tech into big pharma R&D expected to change the world. Instead, they found endless meetings, slow timelines and projects that feel more career-optimizing than patient-impacting. The consensus: “Welcome to big pharma.” Others noted that the loudest voices often rise fastest, while real innovation can get buried in process.

🏆 Do companies pay for ‘Great Place to Work’ badges?
Another thread questioned the shiny awards splashed across LinkedIn job posts. Most agreed the surveys are technically legit but heavily orchestrated, with internal nudges to “share honest feedback.” Some went further, claiming the most toxic environments often display the biggest badges. Moral of the story: until they start posting “red flag” badges, don’t trust the “great place to work” badges.

🏛️ White House Pressure May Have Nudged FDA Reversal. Reports suggest frustration from President Trump preceded the FDA’s rapid reversal on Moderna’s flu vaccine filing.

🩸 Pediatricians’ Blood Yields Antibody Gold. Scientists identified RSV- and hMPV-neutralizing antibodies from doctors constantly exposed to sick kids.

🎙️ AbbVie Launches… a Podcast? The pharma giant is now telling its science stories through a branded audio series spotlighting innovation.

🧫 Cambiotics Wants to Rid Your Gut of “Forever Chemicals”
Copenhagen-based Cambiotics has raised about $4.8 million to develop a probiotic designed to bind PFAS in the gut and help the body excrete them. The idea stems from research showing certain bacteria can absorb these persistent chemicals. The first targets are high-exposure groups like firefighters. If successful, it could turn microbiome science into a consumer-friendly detox play with real environmental relevance.

🌿 February 24, 1743 — Sir Joseph Banks Is Born
The English naturalist sailed with Captain James Cook, catalogued thousands of plant species and later served as president of the Royal Society for more than four decades. He helped transform Kew Gardens into a global botanical powerhouse and championed the international spirit of science. Exploration was his startup model.

Somewhere in Denmark, a PowerPoint titled “Closing the 2.5% Gap” just became mandatory viewing.

Meanwhile, Lilly is probably handing out surprise bonuses.

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

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