Overview
- Regeneron shares fell about 10% to 11% in premarket trading Monday after it disclosed late Friday that the Phase 3 fianlimab plus Libtayo study missed its main goal against Merck’s Keytruda.
- The high-dose combination showed a median progression-free survival of 11.5 months versus 6.4 months on Keytruda, but the difference was not statistically significant with a p-value of 0.0627.
- The randomized, double-blind trial enrolled 1,546 patients across four arms and reported no new safety signals for the fianlimab combination.
- Analysts cut views following the readout, with Citi downgrading Regeneron and trimming its price target to $700 as RBC moved to $707 and Jefferies lowered its target while removing fianlimab from models.
- Levi & Korsinsky launched a securities investigation into whether upbeat remarks about the study misled investors, citing March comments that highlighted hopes for a clear benefit.