Original reporting and analysis on the stories shaping biotech.
AstraZeneca killed its Phase 3 lung cancer trial of volrustomig after the bispecific antibody couldn't outperform Keytruda. The fallout raises uncomfortable questions about whether the industry's obsession with "two-in-one" cancer drugs has been oversold.
RiboX just got FDA clearance to test the world's first circular RNA-based therapy that builds CAR-T cells inside the body, no factory required. It's a collision of two massive biotech trends, and the implications for autoimmune disease are enormous.
Charles River Laboratories just raised its profit forecast, and it's the closest thing biotech has to a recovery signal. As the gas station of drug development, when Charles River's business picks up, the whole industry is starting to spend again.
BioMarin spent $270 million to acquire Inozyme Pharma last year. Now the crown jewel drug from that deal is dead after a Phase 3 trial showed it could fix a biomarker but not the actual disease. Here's what went wrong and what it means for the rare disease giant.
Capricor's Duchenne drug got crushed 9-3 at an FDA advisory committee, and its stock cratered to $4. Then the FDA agreed to review an amended filing, and everything changed overnight. The comeback story Wall Street didn't see coming.
Reports claim FDA Commissioner Marty Makary personally tried to block KalVista's rare disease drug, an almost unprecedented intervention that raises uncomfortable questions about political influence at the agency. The drug got approved anyway, but the fallout is just beginning.
Bristol Myers Squibb just signed a deal worth up to $15.2 billion with China's Hengrui Pharmaceuticals, covering 13 early-stage drug programs. It's one of the year's biggest cross-border pharma transactions, and it's happening despite U.S.-China tensions that should theoretically make deals like this impossible.
European regulators just pulled Amgen's Tavneos off the market, but not because of a scary side effect. They pulled it because the pivotal trial data was manipulated after the study was supposed to be finished. It's one of the rarest regulatory actions ever taken against a major pharma company's approved drug.
Cytokinetics just filed a preemptive patent lawsuit against Bristol Myers Squibb, claiming BMS patented methods covering Cytokinetics' own heart drug despite having "zero involvement" in its development. With a billion-dollar drug class on the line, this fight could reshape the future of cardiac myosin inhibitors.
ITM's cancer drug aced its clinical trials and proved it could help patients live longer without their tumors progressing. Then the FDA rejected it anyway, citing manufacturing problems. It's a cautionary tale for the entire radiopharmaceutical sector.
BioCryst is shutting down its 40-year-old internal drug discovery operation and betting everything on external deals. The rare-disease biotech is profitable, growing, and making a deliberate strategic gamble that could redefine what a mid-cap biotech looks like.
Two small biotechs just merged into Fibrx Therapeutics with $125 million in financing to tackle fibrosis, one of medicine's most stubborn unsolved problems. The catch? Original Skye shareholders got diluted down to just 5.38% of the new company.
Epicrispr just completed enrollment in the first-ever epigenetic editing trial for muscular dystrophy, a therapy that silences disease genes without cutting DNA. Twelve patients are dosed, early signals look promising, and the implications stretch far beyond one rare disease.
A molecule designed entirely by AI just got cleared for clinical trials in Parkinson's disease across three continents. Insilico Medicine's ISM8969 could validate generative AI drug discovery, but Parkinson's has a nasty habit of humbling even the most promising drugs.
Zymeworks, a cancer-focused antibody company, is spending $929 million on a respiratory drug maker. The deal structure is so clever that Wall Street analysts are actually impressed. Here's why a lung inhaler might be the smartest thing to ever happen to an oncology pipeline.
Eli Lilly is pouring $750 million into a manufacturing partnership with Resilience to expand KwikPen production for its GLP-1 blockbusters. In the obesity drug wars, the real bottleneck isn't science; it's making enough pens fast enough.
The Senate just confirmed Erica Schwartz as CDC director after nearly a year without permanent leadership, and the biggest question isn't about her impressive resume. It's whether she'll stand up to her own boss on vaccines.
The FDA just approved the first drug that targets the root cause of narcolepsy type 1, not just its symptoms. Takeda's Orzeyful could open a multibillion-dollar market in sleep medicine, but its most ironic side effect might surprise you.
The FDA just approved the world's first mRNA flu vaccine, and it's not the revenue that matters. Moderna's mFLUSIVA could reshape how regulators, investors, and competitors think about mRNA technology forever.
Zipalertinib just scored its second Phase 3 win in one of lung cancer's most drug-resistant mutations. With J&J's Rybrevant as the reigning champ and an FDA decision date already on the calendar, this oral pill could reshape how doctors treat EGFR exon 20 insertion NSCLC.
PTC Therapeutics just scooped up a near-approval Fabry disease gene therapy from Sangamo's bankruptcy auction for $211 million. It's either the deal of the year or a cautionary tale waiting to happen.
Sarepta Therapeutics slapped the FDA's most severe safety warning on its flagship Duchenne gene therapy after patient deaths, then cut 500 jobs in the same breath. It's the biggest crisis yet for the company that was supposed to prove gene therapy could work at scale.
Join thousands of biotech professionals who start their day with our free, daily briefing.