Past Issues
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The first drug to sneak past the brain's toughest security just got approved
For two decades, kids with Hunter syndrome had a treatment that could fix their organs but couldn't touch their brains. Denali Therapeutics just changed that with the first enzyme therapy to cross the blood-brain barrier, and the implications stretch far beyond one rare disease. Meanwhile, Merck is spending billions to outrun its Keytruda problem, and one biotech learned the hard way what happens when you call your own data "best-in-class."
Merck just dropped $6.7B on a cancer drug with zero revenue
Merck is betting nearly $7 billion on a single cancer drug that hasn't left early-stage trials, and the reason why tells you everything about Big Pharma's looming panic. Meanwhile, Gilead repurposes a cancer weapon for autoimmune disease, the FDA flags a deadly vitamin drain hiding in a common Parkinson's drug, and Sarepta's gene-silencing gambit gets its first human data.
The obesity startup that just slammed the brakes on its entire pipeline
An obesity biotech froze every trial it had after a comprehensive data review raised serious questions about its mechanism. Meanwhile, a war in the Middle East is threatening to disrupt hospital supply chains, and Merck is paying a startup to read your cells' typos like a drug discovery cheat code.
Abbott just wrote a $23B check to kill the colonoscopy
The biggest diagnostics deal of the year just closed, and it's a $23 billion bet that the future of cancer detection fits in a mailbox. Meanwhile, a gene therapy for kids who rarely survive past age two gets a second shot at FDA approval, and a stealth startup claims it can regrow the brain cells that Parkinson's destroys.
This epilepsy drug nearly doubled Wall Street's expectations (stock up 50%)
An epilepsy drug just posted the strongest placebo-adjusted efficacy in pivotal trial history, and the stock responded with a 50% single-day surge. Meanwhile, Pfizer engineered a three-headed antibody to take on a blockbuster worth billions, and Novartis wrote a $2 billion check for a drug with zero clinical data.
Novartis just wrote a $2B check for a drug class everyone left for dead
Novartis dropped $2 billion in cash on a Phase 1/2 breast cancer drug from the one drug class pharma swore off years ago. Meanwhile, biotech's longest-running muscle theory took another beating, and a surgical robot's stapler told surgeons everything was fine when it very much wasn't.
China now runs more CAR-T trials than the country that invented CAR-T
America created one of the most transformative cancer therapies ever made, then watched China build more kitchens, hire more cooks, and serve more patients. Today we unpack how the global biotech balance of power is shifting, plus a century-old syringe maker that just paid $200 million to become something else entirely.
The heart condition that had zero treatments just got its first
A leaky heart valve that's plagued millions of patients finally has a purpose-built fix, and the FDA just greenlit it. Meanwhile, two biotechs watched their stocks evaporate after Phase 3 failures, a polarizing FDA leader walked out the door, and a pill is coming for the injection-dominated psoriasis market.
A daily pill just matched injectable biologics in clearing psoriasis
J&J just got the FDA to approve a once-daily pill that clears psoriasis skin as well as the injectable biologics that have dominated the market for years. No needles, no specialty pharmacies, no excuses. Meanwhile, the FDA itself is looking a little worse for wear after losing 4,000 staffers, and one small biotech just learned that three strikes really does mean you're out.
A cancer drug that wears a disguise just sent a stock up 56%
A tiny biotech's "masked" cancer drug posted jaw-dropping response rates in patients who'd exhausted every option, sending shares soaring roughly 56%. Meanwhile, kidneys are having a moment: three separate stories this week prove nephrology is suddenly the hottest neighborhood in drug development.
One antibody, three targets: the cancer drug that opens locks nobody else can
A Chinese biotech just sent the world's only trispecific antibody into human trials, trying to crack the cold tumor problem that has stumped immunotherapy for a decade. Meanwhile, AI-designed drugs are pulling in record IPO money, a single patient's forearm has been making insulin for 14 months, and the FDA is quietly rewriting the rules for copycat biologics.
Pfizer is racing from a $1.25B licensing deal to Phase 3 launches at unprecedented speed
Pfizer is moving at a pace that makes the rest of pharma look like they're wading through molasses, and it tells you exactly how desperate the oncology arms race has become. Meanwhile, two tiny biotechs are staring down binary moments that will decide whether they survive the year.
China just approved the world's first commercial brain implant. Neuralink didn't.
While Elon Musk's Neuralink is still running clinical trials, a Beijing startup quietly became the first company on Earth to sell a brain-computer interface to hospitals. Meanwhile, Vertex's $5 billion kidney drug bet just paid off in spectacular fashion, and one biotech lost 90% of its value before lunch.
One infusion just replaced a lifetime of ammonia management
A single IV drip might free families from the daily terror of urea cycle disorder, and the data just landed. Plus: biotech turns 50 (and China is crashing the party), device giants are in a land grab for millions of Type 2 diabetics, and a tiny anxiety biotech bets the farm on one last trial.
Novo Nordisk hid patient deaths from the FDA for over 800 days
The biggest name in weight-loss drugs just got caught sitting on serious safety reports, including two deaths and a completed suicide, some filed more than two years late. Meanwhile, bacteria that eat tumors are headed to Wall Street, a new gene editing approach thinks bigger than CRISPR, and Iran just hacked a major medical device company.
BioNTech's founders just quit the company they built from scratch
The married couple behind one of biotech's biggest pandemic success stories is walking away to start over, and BioNTech's stock cratered on the news. Meanwhile, Big Pharma is quietly abandoning the one class of drugs modern medicine literally can't survive without.
This epilepsy drug just posted results so good the stock jumped ~47% in a day
A small-cap neurology company just delivered the strongest placebo-adjusted efficacy ever seen in a pivotal epilepsy trial, and Wall Street responded with a ~47% single-day surge. Meanwhile, three more Phase 3 readouts landed positive results, and GSK sold a drug just two weeks before its FDA decision date. Buckle up.
Roche's breast cancer pill works everywhere except where it matters most
Roche's oral SERD just scored a win in first-line breast cancer, adding to victories in nearly every other setting. Meanwhile, an Italian pharma company bet $300 million on an itch drug with an FDA decision just two weeks away, and one biotech CEO found a $505 million backdoor to Wall Street.
The FDA's biologics chief quit. Again. (This time it's for real.)
The most controversial regulator in biotech just walked away for a second time, leaving the center that oversees gene therapies, vaccines, and CAR-T in limbo. Meanwhile, pharma giants are writing billion-dollar checks for drugs that haven't treated a single patient, and Flagship's tRNA bet just lost its captain.
The CIA is investing in eyeball implants (yes, really)
A Neuralink co-founder just convinced the U.S. intelligence community to back tiny retinal devices, a tRNA pioneer is running out of runway, and Alnylam wrote a billion-dollar check to crack heart disease genetics. Wednesday's shaping up to be a weird one.
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