Original reporting and analysis on the stories shaping biotech.
Bayer's PET tracer nailed 94% sensitivity in a Phase 3 trial for cardiac amyloidosis, a disease that's misdiagnosed more often than it's caught. If approved, it could unlock a massive underdiagnosed patient pool that every major ATTR drug company is desperate to find.
Stargardt disease has robbed young people of their vision for decades with zero approved treatments. Belite Bio's tinlarebant just got FDA Priority Review, and a decision date of February 2027 could mark a rare disease milestone that's been a lifetime coming.
BioXcel Therapeutics filed for bankruptcy with a drug that made just $600K last year. Teva swooped in with a $57.5 million stalking horse bid, betting it can turn a failed launch into a CNS winner. It's a masterclass in distressed biotech deal-making.
The FDA just gave Mounjaro a cardiovascular risk-reduction label, making it the first dual GIP/GLP-1 drug cleared to protect hearts. Eli Lilly just closed the biggest gap between tirzepatide and Novo Nordisk's semaglutide, and the implications for the $50 billion incretin market are enormous.
AstraZeneca's massive ATTR cardiomyopathy trial just failed, and it's not just one drug's problem. The results are raising billion-dollar questions about whether an entire class of RNA silencing drugs can compete with existing heart therapies.
The FDA just approved the first hepcidin mimetic for polycythemia vera, a rare blood cancer where the main treatment has been... draining your blood. Mimrylo works through an entirely new mechanism, and its Phase 3 data might make phlebotomy a thing of the past for thousands of patients.
BioNTech and Genentech killed a personalized cancer vaccine trial after more patients died in the treatment arm than the control group. It's a gut punch for the mRNA-fights-cancer thesis, and it raises uncomfortable questions about which tumors this technology can actually beat.
An Oxford study found that GSK's Shingrix shingles vaccine is linked to 9% lower cardiovascular burden than the older Zostavax. A shingles shot that might also protect your heart? The evidence is intriguing, the caveats are real, and the implications could be enormous.
Cytokinetics' aficamten just proved it works in non-obstructive HCM, a condition affecting hundreds of thousands of patients with zero approved targeted therapies. The ACACIA-HCM trial hit both primary endpoints, and the NEJM published the data the same day it was presented at ESC 2026.
CRISPR Therapeutics just showed that a single IV infusion can slash cholesterol and triglycerides for at least a year by permanently editing a gene in liver cells. The one-year Phase 1a data for CTX310 are stunning, but the jump from 15 patients to the real world is where things get interesting.
Moderna raised $2.6 billion in zero-interest convertible debt to fund its aggressive pivot from COVID vaccines to cancer. With Phase 3 data proving its personalized mRNA cancer vaccine works in melanoma, the company is betting its future on oncology.
The FDA approved updated COVID vaccines from Pfizer, Moderna, and Novavax-Sanofi targeting the XFG variant, and the whole thing felt routine. That normalcy is both a triumph and a warning sign.
Tezspire just crashed Dupixent's monopoly in eosinophilic esophagitis. AstraZeneca and Amgen's TSLP-blocking biologic nailed both primary endpoints in the Phase III CROSSING trial, and the "upstream" mechanism might reshape how we treat allergic diseases across the board.
Genentech is paying up to $1 billion for DualityBio's novel-payload ADC platform, betting that cracking tumor resistance is the next frontier in cancer's hottest drug class. The deal structure says a lot about where pharma thinks the real value lies.
Gilead built lenacapavir's identity around a twice-yearly injection. Now the FDA just approved it inside a daily pill called Bixlenvo, and the logic behind that counterintuitive move reveals Gilead's broader chess match to defend its HIV empire.
The FDA just approved a drug that nearly doubled survival in metastatic pancreatic cancer, a disease that has resisted every major advance in oncology for decades. Wall Street is projecting it could become one of the best-selling drugs in the world.
Alnylam's heart drug vutrisiran has strong clinical data, but a competitor's trial failure, a revenue guidance cut, and a 30% stock drop have created a perfect storm of skepticism. Now the biggest cardiology meeting of the year could decide whether Wall Street buys back in.
The White House is reportedly preparing voluntary drug-pricing deals with midsize biotech companies, extending its Most Favored Nation framework beyond Big Pharma for the first time. For companies with concentrated portfolios and thin financial cushions, the implications could be enormous.
SK Biopharmaceuticals just paid $795 million for a drug that targets the same brain channel class that flopped a decade ago. The early data on opakalim suggests the second-generation version might actually be worth it.
For the first time ever, a gene-editing therapy has been shown to destroy hepatitis B's hidden DNA reservoir in a living patient's liver. The cockroach behind the fridge might finally be catchable.
The investors who built Metsera and sold it to Pfizer for $10 billion just launched a brand-new biotech called Sentivera, complete with a $1.5 billion inflammation deal and a drug nobody's been allowed to see yet. Lightning struck once; now they're chasing the storm again.
The FDA just approved the first-ever targeted pill for dermatomyositis, a rare autoimmune disease that has relied on blunt-force steroids for decades. Roivant's Lisraya could change everything for patients and validate a smart rare-disease-first strategy.
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