Original reporting and analysis on the stories shaping biotech.
Twenty-one biotech companies just launched a brand-new trade alliance, and it's not trying to be the next BIO. With the FDA in chaos, pricing threats mounting, and China closing the gap, the American Biotech Innovation Alliance wants to build a national strategy before it's too late.
Odyssey Therapeutics withdrew its IPO last year. Now it's back asking for $236.6 million, more than double its original target, after burning through $750 million in venture capital without a single approved drug. The 2026 IPO window might be just crazy enough to say yes.
Celcuity's gedatolisib just went two-for-two in Phase 3, proving it works in breast cancer patients regardless of a key genetic mutation. With an FDA decision weeks away and blockbuster ASCO data incoming, this could reshape second-line treatment for the most common form of breast cancer.
The Trump administration went from blocking a psychedelics company's FDA voucher to signing an executive order calling these drugs "life-saving," all in about 60 days. Three companies just got golden tickets that could slash their FDA review from 10 months to under two.
Intellia just posted Phase 3 results for the first CRISPR therapy designed to edit genes inside a living patient. One injection, 87% fewer attacks, and an FDA submission already underway. The gene editing revolution might finally have its breakthrough product.
UCB is paying $2.2 billion for a company that didn't exist publicly until 18 months ago. Candid Therapeutics' T-cell engagers put UCB on a collision course with Gilead in biotech's most competitive arms race: autoimmune disease.
A tiny Minneapolis diagnostics company paid $10 million for a drug Pfizer didn't want. Four years later, it just beat Novartis's Piqray in a head-to-head Phase 3 breast cancer trial, and the implications are enormous.
Esperion Therapeutics is leaving Nasdaq after a decade-long stock collapse, even as its cholesterol drugs post triple-digit revenue growth. Healthcare PE firm ARCHIMED is paying a 58% premium in a deal worth up to $1.1 billion, and the reasons why say a lot about what's broken in small-cap biotech.
Gilead Sciences is unwinding its once-massive oncology alliance with Arcus Biosciences after key lung cancer trials hit a futility wall. With over a billion dollars already invested and a string of recent acquisitions reshaping its cancer strategy, this breakup says as much about where oncology is heading as where it's been.
Merck just committed up to $1 billion over a decade to blanket its entire 75,000-person organization in Google's agentic AI. It's the largest operational AI rollout in pharma history, and it signals that the industry's flirtation with artificial intelligence has become a full commitment.
FOMAT Medical Research just swallowed Topography Health's research sites to become the largest embedded research organization in America. With 27% of trial sites failing to enroll a single patient, this coast-to-coast network is betting it can fix clinical research's most embarrassing problem.
Hemab Therapeutics raised $301.5 million in a massively upsized IPO, then watched its stock surge 89% on day one. The rare blood disease company's blockbuster debut says a lot about where biotech investors are putting their money right now.
Neuropsychiatry drugs fail 95% of the time, yet Seaport Therapeutics just raised $255M in the first brain-focused biotech IPO of 2026. The Karuna Therapeutics co-founder is back with a new platform and a billion-dollar debut.
Ligand Pharmaceuticals just tried to terminate its decade-old partnership with Viking Therapeutics, claiming Viking got so distracted by its blockbuster obesity drug that it forgot about the programs it promised to develop. The legal fight over what "commercially reasonable efforts" actually means could reshape how biotech companies manage their pipeline priorities.
Summit Therapeutics' stock cratered up to 28% after its ivonescimab trial missed a key interim endpoint in squamous lung cancer. For a company that bet $5 billion on dethroning Keytruda, the timing couldn't be worse.
The FDA's biologics center just lost its fifth director in a little over a year. Vinay Prasad's exit leaves CBER in limbo at a moment when gene therapies, cell therapies, and vaccines hang in the balance, and analysts are warning of months of regulatory volatility ahead.
The FDA just approved the first-ever PROTAC, a drug that doesn't just block cancer proteins but destroys them entirely. Vepdegestrant's approval for ESR1-mutated breast cancer validates an entirely new class of medicine, and the implications stretch far beyond one tumor type.
Two Oxford companies are teaming up to decode the genetic roots of autoimmune disease, and their bet could reshape how drug targets are chosen. Genomics Ltd. brings the world's largest gene dataset; Greywolf Therapeutics brings the clinical candidates. The result might just fix your immune system's friendly-fire problem.
The FDA just proposed keeping liraglutide off the 503B Bulks List, potentially blocking compounding pharmacies from making cheaper versions of Saxenda and Victoza at scale. With semaglutide and tirzepatide getting the same treatment, the entire compounded GLP-1 market is under threat.
Merck's islatravir was sidelined in 2021 after tanking patients' immune cells. Four years later, the FDA just approved it as part of a new two-drug HIV pill. The comeback story is wild.
Bristol Myers Squibb just ended an eleven-year bispecific antibody partnership with Zymeworks, torching $313 million in potential milestones. But the real story is what BMS's ruthless portfolio purge tells us about where big pharma is placing its bets.
An FDA advisory panel voted 6-3 against AstraZeneca's plan to use blood tests to trigger early breast cancer drug switches. The rejection challenges the entire premise of preemptive, biomarker-driven therapy and reshapes the oral SERD race.
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