Regeneron 10-Q cites FDA calling for more Dupi data, says RBC Capital

RBC Capital analyst Brian Abrahams keeps an Outperform rating and $1,189 price target on Regeneron but notes that the company’s 10-Q includes some language around the Dupixent COPD regulatory filing, with FDA’s April sBLA review calling for additional analyses from subpopulations of the BOREAS and NOTUS phase III studies by the end of May. Regeneron expects to provide these analyses sooner than that, but acknowledges that if these are considered a major amendment, there could be up to a 3 month delay in the indication vs. the current June 27 PDUFA, the analyst tells investors in a research note.