Pivotal moment, Vaxcyte stock soars 50% on positive phase 3 vaccine data

Landon Capital News

Vaxcyte, Inc. (NASDAQ:PCVX) shares surged 50% Monday following positive topline results from the OPUS-1 pivotal adult phase 3 trial of VAX-31, the company’s 31-valent pneumococcal conjugate vaccine candidate.

VAX-31 met all prespecified primary endpoints across age groups studied compared to Prevnar 20 and Capvaxive. The vaccine demonstrated noninferiority at the >0.667 threshold for all 28 VAX-31 serotypes shared with the comparator vaccines in adults 50 and older, while three serotypes unique to VAX-31 and cross-reactive serotype 20B met superiority criteria.

The trial enrolled 4,047 participants at approximately 30 sites across the United States. Participants aged 50 years and older were randomized to receive a single dose of VAX-31, PCV20, or PCV21, while participants aged 18-49 received VAX-31 or PCV20.

VAX-31 was well tolerated and demonstrated a safety profile similar to PCV20 and PCV21 across all ages studied. No serious adverse events were considered related to study vaccines, and there were no study discontinuations due to adverse events.

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