Financial PerformanceSales of Heplisav-B vaccine came in below Visible Alpha Consensus Data, raising concerns about the company's financial health.
Pipeline ConcernsAbsence of near-term derisking catalysts for the company's early-stage pipeline, which is likely to remain in a holding pattern for the foreseeable future.
Regulatory IssuesThe FDA issued a Complete Response Letter for Heplisav's supplemental application in adults on hemodialysis citing insufficient data due to the destruction of records by a trial site.