Original reporting and analysis on the stories shaping biotech.
Novo Nordisk just killed a $285 million partnership with Ascendis Pharma to develop a once-monthly GLP-1 obesity shot. In the middle of the biggest obesity drug race in history, why would you hand back that asset? The answer says a lot about where the market is heading.
J&J and Contineum's rapid-acting depression drug just failed its second Phase 2 trial, and it's part of a brutal streak for novel antidepressant mechanisms. Wall Street barely flinched, but the implications for beyond-SSRI psychiatry are worth paying attention to.
Cullinan and Taiho's oral cancer drug zipalertinib just posted a six-month survival advantage over chemo alone in a rare form of lung cancer, and the numbers look better than J&J's market-leading Rybrevant. The catch? The most important data point is still cooking.
Electra Therapeutics just filed for a nearly $1 billion IPO built around a protein family most investors have never encountered. In a biotech market that spent three years on life support, this deal could signal whether the recovery is real or wishful thinking.
Cellectis, one of the original pioneers of off-the-shelf CAR-T therapy, just abandoned its two lead programs and pivoted entirely to in vivo gene editing. After a decade of work and zero approvals across the entire allogeneic field, the move raises big questions about the future of donor-derived cell therapy.
J&J's amivantamab combo just posted the longest survival ever in a rare lung cancer subtype: 34.3 months. But the key statistical test came back negative, and a rival oral drug is gaining ground fast. The full story is more nuanced than the headline.
Definium Therapeutics just nailed its third consecutive Phase 3 win for an LSD-based anxiety pill, putting psychedelic medicine on a clear runway to FDA submission. Analysts now see approval as high as 95% likely, with a potential green light by end of 2027.
The FDA just approved the first-ever PET imaging agent designed specifically for glioma, and it could end one of brain cancer's most frustrating guessing games. Telix Pharmaceuticals' Pixclara doesn't just find tumors; it tells doctors whether what they're seeing is real cancer or just the brain reacting to treatment.
Vyriad just dosed the first patient in a trial that could turn the entire CAR-T manufacturing model inside out. Instead of building cancer-killing cells in a factory, VV169 tries to build them inside the patient's own body.
Gilead's Trodelvy missed both primary endpoints in a pivotal first-line lung cancer trial, sending shares tumbling roughly 10%. The failure doesn't just hurt Gilead; it raises tough questions about how far TROP-2 antibody-drug conjugates can reach beyond breast cancer.
Gilead's twice-yearly lenacapavir injection produced just 2 HIV infections out of 2,180 people in the PURPOSE 2 trial, crushing daily Truvada by 89%. The science is settled; now comes the hard part.
The FDA just approved the first-ever treatment for Barth syndrome, a rare mitochondrial disease affecting fewer than 250 people worldwide. The twist? The drug's pivotal trial technically failed. How Stealth BioTherapeutics pulled off one of biotech's most improbable comebacks.
GSK's antibody-drug conjugate just posted 18.5 months of median overall survival in relapsed small cell lung cancer, nearly doubling the standard of care. The result puts GSK on a collision course with Amgen and Merck in one of oncology's toughest markets.
AstraZeneca's breast cancer pill camizestrant just won FDA approval despite a 3-6 negative advisory committee vote, one of the rare cases where the agency overruled its own experts. The decision could reshape how sponsors approach borderline drug approvals.
The FDA just approved the first-ever treatment for Alexander disease, a brain disorder so rare that only about 500 cases have ever been documented. Ionis Pharmaceuticals' Zanvastro could reshape how the industry thinks about ultra-rare diseases, and the $1.14 million annual price tag barely raised an eyebrow.
Three patient deaths forced Novartis to halt its autoimmune CAR-T program, and BMS paused its own shortly after. The hottest idea in autoimmune medicine is now facing the hardest question in drug development: when is the cure more dangerous than the disease?
GSK is pushing an mRNA flu vaccine into Phase 3 trials, directly threatening its own £303 million egg-based flu franchise. With Moderna already FDA-approved and Pfizer closing in, the legacy vaccine giant would rather cannibalize itself than get left behind.
A tiny California biotech just published Lancet data showing its CAR-T therapy worked in patients who'd already failed the standard CAR-T approach. Nine patients, seven complete responses, zero relapses so far. The catch? It's Phase 1, and nine patients is barely a dataset.
Sarepta hit its Duchenne gene therapy Elevidys with the FDA's most serious safety warning after fatal liver failures, then cut 36% of its workforce in the same week. It's the biggest crisis yet for one of gene therapy's most prominent companies.
Takeda's oveporexton just swept every endpoint in two Phase 3 narcolepsy trials by replacing the brain signal that's actually missing. It's the first time anyone has proven orexin receptor agonism works in late-stage testing, and it could reshape how we think about sleep disorders.
A new antibody-drug conjugate just cut the risk of death by 54% in one of cancer's most untreatable forms. Roche bet $570 million on it months ago, and the Phase 3 data suggest that bet is paying off.
For the first time ever, a drug has beaten Keytruda head-to-head in first-line lung cancer, on both progression-free survival and overall survival. The challenger? A Chinese bispecific antibody that attacks tumors from two directions at once.
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