Vaxcyte reports Q2 EPS ($1.22), consensus ($1.16)

“We are laser-focused on advancing the development of VAX-31 in both adults and infants, given its potential to meaningfully elevate the standard-of-care by broadening protection against invasive pneumococcal disease,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte (PCVX). “For the adult indication, following a series of interactions with the FDA, including an End-of-Phase 2 meeting, we are finalizing the Phase 3 program, the results of which we believe could validate the best-in-class potential of VAX-31. This work includes final-stage planning for the pivotal, non-inferiority study, which we intend to initiate in the fourth quarter of this year with topline data expected in 2026, consistent with prior readout guidance. We look forward to delivering multiple anticipated Phase 3 data readouts in 2026 and 2027 to support our potential BLA submission for the VAX-31 adult indication. For the infant indication, we have leveraged key insights from the robust VAX-24 and VAX-31 data generated to date, as well as our carrier-sparing platform, to support the evaluation of a new, Optimized dose in the ongoing VAX-31 Phase 2 dose-finding study to elicit even stronger immune responses in this population. We expect the modified study to proceed by the end of the third quarter of this year with topline data from both the primary immunogenicity series and the booster dose expected by the end of the first half of 2027. We believe the incorporation of this new, Optimized dose arm, which results in a minor extension to our prior readout timeline, best positions VAX-31 for long-term success.”