Pfizer and Valneva’s Lyme disease vaccine cut cases by about 73% in a Phase 3 trial, but missed its primary statistical endpoint — setting up a tricky regulatory path despite strong efficacy and safety signals.
Meanwhile, a new Parkinson’s startup is betting on personalized neuron replacement, Insmed moves to expand Arikayce earlier in disease, Apogee touts a longer-lasting eczema drug, and geopolitical tensions begin to strain drug supply chains.
Pfizer’s Lyme data has an awkward statistical miss
Pfizer and Valneva’s Lyme disease vaccine looks meaningfully effective, cutting cases by about 73% in a large Phase 3 trial. But the inoculation failed its primary endpoint: The confidence interval came in below the pre-specified threshold, a miss that could complicate regulatory review despite the overall data and safety profile looking solid, STAT’s Matthew Herper writes.Continue to STAT+ to read the full story…