Vaxcyte Q3 loss smaller than estimates; plans VAX-31 filing in first half of 2028
PCVX•Vaxcyte reported a third-quarter net loss of $297.06 million, below analysts’ $310.72 million estimate, and plans to submit a biologics license application for VAX-31’s adult indication in the first half of 2028.
1. Quarterly results
Vaxcyte reported a third-quarter net loss of $297.06 million, compared with an analyst consensus estimate of $310.72 million. Operating expenses were $308.27 million, up 27% year over year, driven by higher VAX-31 trial and manufacturing costs, as well as personnel expenses.
2. VAX-31 milestones
VAX-31 met all prespecified primary endpoints in the pivotal Phase 3 OPUS-1 adult trial and showed a safety profile similar to PCV20 and PCV21. Vaxcyte expects results from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027 and VAX-31 infant Phase 2 topline data by the end of that half.
3. Filing plans
Vaxcyte plans to submit a biologics license application for VAX-31’s adult indication in the first half of 2028. Higher research and development and manufacturing costs for its pneumococcal conjugate vaccine programs, along with increased general and administrative headcount and professional services, contributed to rising expenses.
