Vaxcyte's VAX-31 Hits All Primary Endpoints in Pivotal Phase 3, BLA Filing Set for 2028
PCVX sits 93% above its 52-week low of $37.694 on elevated volume (2.1× avg).
Summary
Vaxcyte reported positive topline data from OPUS-1, the pivotal adult Phase 3 trial of its 31-valent pneumococcal conjugate vaccine candidate VAX-31. The vaccine met all prespecified co-primary immunogenicity endpoints in adults 50 and older, including noninferiority for all 28 shared serotypes and superiority for three unique serotypes plus cross-reactive 20B. Safety was similar to PCV20 and PCV21. The company plans to submit a Biologics License Application in the first half of 2028, with OPUS-2 and OPUS-3 results expected in the first half of 2027. This is a major de-risking event for the lead asset and validates the carrier-sparing platform. The stock is trading near its 52-week high, and this news could drive further upside as the market prices in approval probability.
Updates
· SEC 8-K — The 8-K attaches the press release and slide presentation; VAX-31 met all prespecified primary endpoints, including noninferiority for 20 of 20 serotypes shared with PCV20 and 17 of 19 shared with PCV21, with serotypes 3 and 12F meeting the historical >0.5 threshold.
At the time of this announcement, PCVX was trading at $72.80 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $8.4B. The 52-week trading range was $37.69 to $65.00. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.