Stifel calls report of Makary pushing for KalVista CRL ‘highly surprising’

After Endpoints News reported that FDA Commissioner Dr. Marty Makary requested drug reviewers to issue a Complete Response Letter for sebetralstat, with no specific reason cited, Stifel called it “bizarre,” “highly surprising” and “unusual” for the commissioner to intervene on the review of a drug, especially given what the firm views as “the strong data package” submitted by KalVista (KALV). These reports, along with the recent departure of CBER’s Nicole Verdun, are likely to raise continued concerns from investors that the regulatory landscape is still somewhat uncertain, adds the analyst, who has a Buy rating on KalVista shares.