Gilead, Regeneron have most theoretical PDUFA date risk, says BofA

With the FDA appearing to be undergoing major disruption under new leadership, BofA analyst Tim Anderson says one way to assess the risk from an “FDA in disarray” is to analyze who has new drug applications sitting at FDA undergoing review and products where regulatory decisions are likely to be made within the next roughly 12 months. All 11 large-cap pharma names the analyst covers are likely to have regulatory decisions made at some point over the next 12 months, notes the analyst, who argues that it is not the number of products that matter, but the importance of the products to the “story.” ” In that sense, Gilead (GILD) with lenacapavir and Regeneron (REGN) with Eylea label expansion and new formulation “theoretically have the most risk,” followed by Merck (MRK) with subcutaneous Keytruda, the analyst tells investors. While the firm adds it is “not saying these are ‘risky’ approvals per se,” BofA notes that these approvals likely matter more than most others, so “hopefully they won’t get caught in the FDA downdraft.”