Original reporting and analysis on the stories shaping biotech.
Alkermes just dropped early data on ALKS 7290, a drug that treats ADHD through an entirely different brain system than any existing therapy. It's the first time an orexin agonist has shown clinical benefit in ADHD, and the implications for a $17+ billion market are hard to ignore.
Sarepta slapped a black box warning on its Duchenne gene therapy Elevidys and cut 36% of its workforce in one brutal announcement. The fallout raises hard questions about the commercial future of accelerated-approval gene therapies in rare disease.
Viking Therapeutics just dropped obesity drug data that sent Novo Nordisk tumbling 7% and put the Lilly-Novo duopoly on notice. A $3.5 billion biotech making giants flinch in a market headed for $200 billion: here's why it matters.
Novo Nordisk showed up to its Capital Markets Day with a sweeping new strategy, a DTC push, and plans to cut 4,000 jobs. The stock dropped 7%. Here's why investors wanted more from the GLP-1 giant losing ground to Eli Lilly.
After nearly two decades of failed myostatin drugs, Scholar Rock's Isembyld just became the first FDA-approved SMA therapy that targets muscle directly. It's not a replacement for existing gene-correcting treatments; it's the missing second half of the equation.
A thyroid hormone drug just posted striking Phase 2 results in bipolar depression, a condition with notoriously few good treatment options. Autobahn Therapeutics' elunetirom doesn't touch serotonin or dopamine; it targets the brain's cellular energy instead.
Bristol Myers Squibb just deployed the most powerful AI supercomputer in life sciences, expanding a three-year Nvidia partnership to power its entire drug discovery pipeline. As pharma's AI spending rockets toward $25 billion by 2030, the real question isn't whether the hardware works; it's whether it produces better drugs.
Alexander disease is so rare it affects roughly 1 in 2.7 million people, and for decades it had exactly zero approved treatments. Ionis just changed that with the first-ever FDA approval, and the implications go well beyond one ultra-rare condition.
Alkermes just showed that an orexin 2 receptor agonist, a class of drug known for regulating wakefulness, can improve ADHD symptoms in adults. If the Phase 2 confirms it, this could be the first genuinely new ADHD mechanism in decades.
Beacon Therapeutics just became the first company to hit a pivotal endpoint in XLRP, a blinding inherited disease with zero approved treatments. Their one-shot gene therapy could rewrite the playbook for patients who've had nothing but a front-row seat to their own vision loss.
Telix Pharmaceuticals is spending up to $2.35 billion to acquire ITM Isotope Technologies Munich in the largest mid-cap radiopharmaceutical deal ever. The move gives Telix isotope manufacturing, a late-stage therapeutic pipeline, and a direct path to challenge Novartis's dominance in radioligand therapy.
The FDA just approved a new first-line combo for triple-negative breast cancer's toughest cases, pairing Merck's Keytruda with Gilead's Trodelvy. The results leapfrog the current standard of care, but Wall Street's excitement comes with a catch.
Novo Nordisk just scooped up three non-incretin obesity programs from Kallyope, a gut-brain biotech backed by Bill Gates and nearly half a billion in venture funding. The move is a clear signal that the king of GLP-1 drugs thinks its crown jewel mechanism won't be enough to stay on top.
Transgene's personalized cancer vaccine TG4050 posted 100% disease-free survival across all 16 treated patients at three years in a head-and-neck cancer trial. The study is tiny, but in a disease that kills half its patients within five years, a perfect score is impossible to ignore.
Italian pharma giant Menarini just bet €726 million on a Chinese-made obesity drug for 39 European markets. The deal highlights a surprising trend: Western pharma companies are increasingly raiding Chinese biotech pipelines for their next blockbuster weight-loss drugs.
Novo Nordisk just dropped half its name, rebranding to simply "Novo" in a bid to become a consumer health powerhouse. It's either a masterstroke of brand strategy or expensive wallpaper without a plan behind it.
Zealand Pharma's Zeydovio just got a thumbs-up from Europe's top drug regulators, putting it on track to become the first major new treatment for short bowel syndrome in over a decade. For patients who spend multiple nights a week hooked up to IV nutrition, this could be a game-changer.
The FDA just launched a pilot program to speed up first-in-human drug trials in the U.S., and it works completely differently from any expedited pathway before it. If it succeeds, it could pull early-stage clinical work back from Australia and Asia, where American biotechs have been fleeing for years.
GSK just committed up to $1.295 billion for a cancer drug that hasn't been tested in a single patient. The molecule attacks tumors through two targets at once, and it tells you everything about how frenzied the ADC market has become.
Roche just licensed a preclinical trispecific antibody from China's Simcere Zaiming for up to $1.53 billion, and the drug hasn't even been tested in humans yet. The deal reveals how far big pharma will go to win the next-generation blood cancer arms race.
Huntington's disease has defeated every drug that's tried to slow it. Skyhawk Therapeutics just posted 15-month data on an oral pill that improved patients across every clinical measure tested. The catch? It still needs to prove itself in a bigger trial.
AstraZeneca's oral breast cancer pill camizestrant missed its primary endpoint in the pivotal SERENA-4 trial, failing to prove a statistically significant benefit in first-line advanced breast cancer. The setback narrows the drug's commercial ceiling just as Eli Lilly's competing therapy racks up its second FDA approval.
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