Vaxcyte narrows VAX-31 data timing to late October

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Vaxcyte expects to report topline results from its pivotal Phase 3 OPUS-1 trial of the pneumococcal vaccine candidate VAX-31 by the end of October, narrowing its previous guidance for a fourth-quarter readout. The OPUS-1 study, which is part of a three-trial adult program involving 6,191 participants, will provide safety, tolerability, and immunogenicity data from a noninferiority study in adults. The company also appointed former Pfizer vaccine executive Luis Jodar as chief medical officer and David McAvoy, formerly of Teva Pharmaceutical Industries, as chief legal officer, as it prepares for a potential Biologics License Application and commercial launch. VAX-31 is the broadest-spectrum pneumococcal conjugate vaccine in clinical development, designed to protect against 31 bacterial serotypes, and results from the other two trials, OPUS-2 and OPUS-3, are expected in the first half of 2027.

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Vaxcyte Inc
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Narrowing VAX-31 data timing to late October and progress in Phase 3 trials are positive for Vaxcyte.

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