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Dynavax Technologies (Nasdaq: DVAX) announced that the U.S. FDA has issued a Complete Response Letter (CRL) regarding its supplemental Biologics License Application (sBLA) for a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis. The CRL cited insufficient data to fully evaluate the effectiveness and safety of the regimen, due to the destruction of data source documents and an inadequate sample size in the HBV-24 study. This decision does not impact the current approved indications for HEPLISAV-B in the U.S., EU, and Great Britain, nor the European Commission's approval of the four-dose regimen for hemodialysis patients. Dynavax plans to meet with the FDA to explore options for providing additional data.
Dynavax reported $48 million in HEPLISAV-B vaccine net product revenue, a 10% increase year-over-year in Q1 2024. The company reaffirmed its full-year revenue guidance and FDA clearance to initiate Phase 1/2 trial of Z-1018 shingles program. Dynavax continues to evaluate strategic growth opportunities while focusing on expanding its hepatitis B vaccine market share.