From PDUFA Dates to Phase Data — We Track What Moves the Stock
We track every PDUFA date, clinical trial readout, and FDA advisory committee meeting. We break down what the science means in plain English — no PhD required. If it moves a biotech stock, we're on it.
See the FDA Calendar →AbbVie reported Phase 3 CERVINO topline results: etentamig delivered a 74% objective response rate and a 60% reduction in progression risk (HR 0.40) versus standard therapy in triple-class exposed relapsed/refractory multiple myeloma, with a low-grade CRS and monthly dosing profile.
The FDA approved Zanvastro (zilganersen) for Alexander disease, the first treatment for the ultra-rare and often fatal GFAP-driven neurological disorder. Ionis earned a Rare Pediatric Disease Priority Review Voucher and will launch the drug in the US while Recordati handles ex-US rights.
Novartis reported positive topline results from the identical REMODEL-1 and REMODEL-2 Phase 3 trials of oral BTK inhibitor remibrutinib in relapsing multiple sclerosis, beating teriflunomide on annualized relapse rate with no liver safety signal. Remibrutinib is the first BTK inhibitor to pair Phase 3 MS efficacy with a clean liver profile.
FDA Calendar — PDUFA Dates, Advisory Panels, Trial Readouts
Checkpoint inhibitors, CAR-T cell therapies, and antibody-drug conjugates driving the next wave of approvals.
CRISPR, base editing, and AAV-delivered one-time treatments — binary risk, massive upside if they work.
Beyond COVID: mRNA platforms expanding into oncology, rare disease, and personalized vaccines.
Orphan drug designations, ultra-rare indications, and the pricing power that comes with tiny patient populations.
Alzheimer's, Parkinson's, and ALS — historically the graveyard of biotech, but new mechanisms are showing promise.
Vaccines, antivirals, and antibiotics. Pandemic preparedness funding is a new tailwind.