Original reporting and analysis on the stories shaping biotech.
Novo Nordisk's hemophilia A drug denecimig aced its clinical trials. But the FDA just delayed its review anyway, and the reason has nothing to do with the drug itself. Sometimes the factory is the final boss.
BridgeBio's BBP-418 didn't just slow decline in a rare muscular dystrophy trial; it pushed cardiac biomarkers back toward healthy levels. With an FDA decision weeks away, these results could rewrite the playbook for a disease with zero approved treatments.
Nine pharma chairs from companies like Roche, Novo Nordisk, and Sanofi co-signed a letter warning that Europe's biotech sector is in decline. The numbers behind their alarm are worse than you think.
Daiichi Sankyo and Merck pulled their FDA application for a lung cancer ADC just two weeks before the decision date. The reason signals a seismic shift in how the FDA evaluates accelerated approvals, and dozens of ADC programs should be worried.
Roche and Ionis's RNA drug sefaxersen just cleared a major Phase 3 hurdle in IgA nephropathy, proving it can significantly reduce kidney-damaging protein leakage. But with six drugs already approved for the disease, the real question is whether being seventh is good enough.
Genmab's experimental ADC rinatabart sesutecan posted a 45.9% response rate in platinum-resistant ovarian cancer, where standard chemo barely cracks 15%. The durability data might be even more impressive.
Eli Lilly is selling Zepbound in cheaper single-dose vials starting at $299 a month, regardless of insurance status. It's a bold play to crack open the massive population of patients who've been priced out of GLP-1 obesity drugs.
Cutaneous lupus has zero FDA-approved treatments, and patients have been stuck borrowing drugs from other diseases for decades. Biogen's litifilimab just posted 52-week data showing its skin-clearing effects actually improve over time, setting up a pivotal Phase 3 readout in 2027.
GSK just dropped $110 million on a KRAS drug that hasn't treated a single patient, and the total deal could hit $1.3 billion. The HUTCHMED partnership reveals just how frenzied the race to crack cancer's most notorious target has become.
Eli Lilly is spending up to $2.3 billion to buy Ajax Therapeutics and its next-gen JAK inhibitor, betting it can fix a drug class the FDA once branded with boxed warnings. It's the boldest signal yet that pharma thinks the JAK story is far from over.
Genmab is dropping $8 billion in cash to acquire Merus and its experimental cancer drug petosemtamab. It's the biggest pure-play biotech deal of the year, and the phase 3 data hasn't even read out yet.
Three Chinese biotechs inked $11.7 billion in Western pharma deals in a single week, all from Shanghai's sprawling Science City district. China's biotech corridor isn't just catching up anymore; it's becoming the world's biggest drug-licensing bazaar.
Hansoh Pharmaceutical just posted Phase 3 obesity data that rivals Eli Lilly's best-in-class numbers, and the weight loss curve wasn't even done climbing. The Novo-Lilly duopoly has a new problem, and it's coming from China.
The FDA just built an entirely new office because China's drug development machine is catching up. The agency is speeding up domestic trials while tightening scrutiny on foreign data, and the competitive implications for U.S. biotech are massive.
The FDA just cleared pirtobrutinib for first-line CLL/SLL treatment, giving Eli Lilly a mechanistically unique weapon in a $13 billion blood cancer market. The clinical data behind it is borderline ridiculous, and the competition should be nervous.
Merck KGaA is spending $11.3 billion on a company that sells proteins and antibodies to lab scientists. It's the German giant's biggest acquisition in over a decade, and it says a lot about where the real value in drug discovery lives.
Xaira Therapeutics just unveiled X-Design, an AI platform it claims can produce clinic-ready antibodies in weeks instead of years. Backed by over $1 billion and a CEO who ran Genentech's science, this is one of the biggest bets in AI drug discovery.
Florida's Attorney General just sued Pfizer and its CEO over alleged deceptive COVID vaccine marketing, and this time it's not a criminal investigation. It's a consumer protection lawsuit that could rewrite the rules for how pharma companies talk about their products.
Edwards Lifesciences just won FDA approval for a pediatric heart valve that can be expanded as a child grows, potentially ending the cycle of repeat open-heart surgeries. It's also the first approved valve ever to use synthetic polymeric leaflets instead of animal tissue.
Ractigen Therapeutics just showed that RNA activation, a technology designed to turn genes ON instead of off, works in humans for the first time. The Duchenne muscular dystrophy data are early, but the implications for genetic medicine could be enormous.
Bayer is pouring $2.2 billion into its first-ever North American pharma manufacturing campus in Ohio. The move signals the German giant's biggest bet yet on U.S.-made drugs, but the factory won't produce a single pill until 2031.
Generate Biomedicines just raised $400 million in one of the year's biggest biotech IPOs, betting that AI can design drugs better than humans. Wall Street is mostly buying the story, but the stock's first-day stumble tells a more complicated tale.
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