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The Cancer Vaccine That Backfired
BioNTech and Genentech killed a Phase 2 trial of their personalized mRNA cancer vaccine after an independent review found futility and a numerical imbalance in overall survival favoring the control group, though the company said no new safety signals were identified. The vaccine, autogene cevumeran, was targeting colorectal cancer patients at risk of recurrence after surgery. The safety board had flagged futility back in October 2025, but the latest data crossed a more alarming line. The failure stands in stark contrast to Moderna and Merck's positive Phase 3 melanoma results with similar technology, sharpening a critical divide: mRNA vaccines may work in "hot" tumors like melanoma but struggle against immunologically "cold" cancers like colorectal.
Why it matters: This trial didn't just miss its endpoint; it pointed in the wrong direction. The result forces a reckoning over which cancers personalized mRNA vaccines can realistically tackle, and it may accelerate BioNTech's pivot toward non-mRNA assets like antibody-drug conjugates.
Read more →Clinical and Regulatory
The Drug That Could Make Blood Draws Obsolete for Thousands
The FDA approved Mimrylo (rusfertide), the first-ever hepcidin mimetic, for polycythemia vera, a rare blood cancer whose primary treatment has been literally draining patients' blood. In the Phase 3 VERIFY trial, 76.9% of patients on Mimrylo avoided phlebotomy eligibility versus 32.9% on placebo. The once-weekly injection works by starving bone marrow of the iron it needs to overproduce red blood cells: turning off the faucet instead of mopping the floor.
Read more →Mounjaro Just Earned Its Heart Badge
The FDA granted Mounjaro a cardiovascular risk-reduction label, making tirzepatide the first dual GIP/GLP-1 drug cleared to protect hearts in high-risk type 2 diabetes patients. The SURPASS-CVOT trial proved noninferiority against Lilly's older drug dulaglutide on major cardiac events. That erases one of Novo Nordisk's biggest talking points for semaglutide and reshapes the $50 billion incretin market into a genuine two-horse race.
Read more →Aficamten Crashes the Non-Obstructive HCM Party
Cytokinetics showed that aficamten works in non-obstructive HCM, a condition affecting hundreds of thousands of patients with zero approved targeted therapies. The Phase 3 ACACIA-HCM trial hit both co-primary endpoints for quality of life and exercise capacity, with simultaneous publication in the New England Journal of Medicine. Bristol Myers Squibb's rival mavacamten failed its own non-obstructive trial, giving Cytokinetics a potential first-mover advantage.
Read more →Science and Discovery
One CRISPR Shot, One Year of Cholesterol Control
CRISPR Therapeutics presented one-year Phase 1a data showing a single IV infusion of CTX310 reduced LDL cholesterol by a mean of approximately 53% and triglycerides by approximately 48% at the highest dose, with individual reductions reaching as high as 84% and 78% respectively. The therapy permanently edits the ANGPTL3 gene in liver cells, mimicking a natural genetic advantage found in people born with low cholesterol. Only 15 patients so far, but the durability from one dose is remarkable.
Read more →AstraZeneca's RNA Silencer Flopped. The Whole Class Felt It.
The full CARDIO-TTRansform results, published in the NEJM at ESC 2026, confirmed that AstraZeneca's eplontersen failed to improve cardiac outcomes in ATTR cardiomyopathy patients. The culprit: most patients were already on stabilizer therapy, leaving little room for the RNA silencer to add benefit. A monotherapy subgroup showed promise (29% risk reduction), but the overall miss raises class-wide questions for gene-silencing drugs in cardiology.
Read more →A Shingles Vaccine That Might Protect Your Heart
An Oxford-led study of 72,000 people found that GSK's Shingrix was linked to 9% lower cardiovascular burden over seven years compared to the older Zostavax vaccine. Heart failure risk dropped 12%, ischemic heart disease fell 10%. The findings are observational, not proof of causation, but they add to growing evidence that vaccines can have surprising "pleiotropic" benefits well beyond their intended targets.
Read more →Deals and Financings
Moderna Borrows $2.6 Billion at 0% Interest to Bet on Cancer
Moderna raised $2.6 billion in zero-coupon convertible notes maturing in 2032, essentially getting an interest-free loan from investors betting the stock tops $210. The capital fuels Moderna's aggressive pivot from declining COVID revenue toward oncology, anchored by 5-year follow-up data from the Phase 2b KEYNOTE-942 study showing its personalized mRNA cancer vaccine cut melanoma recurrence by 49%. Shares dropped 6% on dilution concerns, but the terms signal real Wall Street confidence in the cancer thesis.
Read more →Teva Bids $57.5M for a Drug That Made $642K Last Year
BioXcel Therapeutics filed for Chapter 11 bankruptcy, and Teva swooped in as the stalking horse bidder for its only product, IGALMI, a sublingual sedation film for acute psychiatric agitation. The drug flopped commercially under BioXcel (just $642K in 2025 revenue), but a pending FDA application for at-home use could transform its market. Total deal value could reach $145 million if milestones hit.
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