Original reporting and analysis on the stories shaping biotech.
GSK sold its PBC itch drug linerixibat to Alfasigma for up to $690 million, then the FDA approved it days later. Here's why both companies think they got the better end of the deal.
Xenon Pharmaceuticals' epilepsy drug just posted Phase 3 results so strong that the stock surged 41% in a single day. With the highest placebo-adjusted efficacy ever seen in a pivotal epilepsy trial and an FDA filing planned for later this year, this is one dataset Wall Street couldn't ignore.
Rapport Therapeutics just handed Greater China rights for its novel epilepsy drug to Tenacia in a deal worth up to $328 million, and the asset hasn't even started Phase 3 yet. The bet: a brain-region-selective approach to seizures that could finally ditch the brutal side effects of current treatments.
Novartis dropped $2 billion upfront on a breast cancer drug that won't have clinical data until 2027. With Eli Lilly's competing asset already in Phase 3, the deal is either a masterstroke of early positioning or one of the most expensive gambles in oncology M&A.
Gilead dropped its option on Assembly Biosciences' hepatitis B drug ABI-4334, even as it doubled down on the same partner's herpes and hepatitis delta programs. With GSK's bepirovirsen nailing two Phase III trials, the HBV cure race just got a lot more selective.
Pfizer's first-in-class trispecific antibody tilrekimig just posted Phase 2 results that rival Dupixent in atopic dermatitis, hitting all three moles at once by blocking IL-4, IL-13, and TSLP simultaneously. With Phase 3 planned for 2026 and expansion into asthma and COPD on the horizon, the $15 billion blockbuster might finally have real competition.
Gilead Sciences just walked away from Assembly Biosciences' hepatitis B drug, returning a Phase 1b asset and $330 million in potential milestones. With 80+ companies chasing an HBV cure and GSK's bepirovirsen hitting Phase 3 endpoints, the rejection says more about the crowded field than it does about one drug.
Genentech killed its anti-myostatin antibody emugrobart after Phase 2 trials in two muscle-wasting diseases came up empty. The failure extends a two-decade losing streak for the entire drug class, and it raises pointed questions about whether the obesity pivot investors are banking on will fare any better.
Novartis just paid $2 billion upfront for a Phase 1/2 breast cancer drug in a class notorious for toxic side effects. It's either the boldest oncology bet of the year or one of pharma's most expensive gambles.
Eric Topol, one of medicine's most influential voices on AI and prevention, just signed on as an advisor at Flagship Pioneering. The move signals Flagship's deepening commitment to preemptive medicine, and it tells you a lot about where biotech's smartest money is heading.
Intuitive Surgical recalled stapler cartridges for its da Vinci robot after one patient death and four serious injuries, all caused by a glitch where the system told surgeons the staples fired correctly when they hadn't. The fallout could reshape how the FDA monitors the fast-growing robotic surgery market.
CAR-T cell therapy was invented in America, but China now runs more clinical trials and enrolls patients twice as fast. With U.S. research funding under pressure and China's R&D spending pulling even, the global biotech balance of power is shifting faster than most people realize.
MiniMed just got FDA clearance for the Flex, an insulin pump that's half the size of its predecessor and has no screen at all. In a market dominated by Insulet's tubeless Omnipod, this is MiniMed's boldest move yet to prove it can compete on lifestyle appeal.
Embecta, the century-old insulin syringe giant, just dropped $200 million on a UK auto-injector maker called Owen Mumford. It's the clearest signal yet that the company wants to be something much bigger than needles.
Vinay Prasad's ten-month tenure atop the FDA's biologics division was defined by drug rejections, staff clashes, and a brief firing. His exit could reshape how fast new gene therapies and vaccines reach patients.
Immutep's stock lost nearly 89% of its value in a single morning after regulators pulled the plug on its flagship Phase 3 lung cancer trial. A 15-year bet on a novel immunotherapy approach just hit the wall.
The FDA just approved the first-ever transcatheter device specifically designed for aortic regurgitation, a leaky heart valve condition that's had no dedicated interventional treatment until now. JenaValve's Trilogy system beat every benchmark the FDA set, and cardiologists are calling it a new standard of care.
The FDA just approved the first oral peptide that targets the IL-23 pathway for plaque psoriasis, delivering biologic-level skin clearance in a once-daily pill. ICOTYDE could reshape how millions of patients manage their disease, and a $7 billion market along with it.
Crossbow Therapeutics just banked $77 million from Taiho Ventures, Pfizer, and Eli Lilly for antibodies that can see inside cancer cells. Their Phase 1 is already running, and the data readout is months away.
A stealth biotech just raised $77.5 million to replace the chalky, metallic pills that dialysis patients choke down 10 times a day. The investors fighting to get in include some of the biggest names in kidney care, and the science behind AP306 is unlike anything currently on the market.
Bicycle Therapeutics just axed 30% of its staff and shelved its most promising cancer drug after the FDA rejected the trial as an approval path. The pivot to radioconjugates is bold, but can a company rebuild its identity around earlier-stage assets?
Gossamer Bio's lead PAH drug missed its Phase 3 goal by the thinnest statistical margin imaginable. Now 77 employees are out, the stock is down 80%, and the company is fighting for survival with $137 million and a prayer.
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