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Vaxcyte Surges 50% After VAX-31 Hits All Phase 3 Goals, Launches $1 Billion Capital Raise

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Vaxcyte, Inc. $PCVX

$73.96+30.95%as of publication

5D Change
+26.93%
Notional
$1.04B

Vaxcyte shares surged roughly 50% on October 5 after its 31-valent pneumococcal conjugate vaccine candidate, VAX-31, met all prespecified primary endpoints in OPUS-1, the pivotal adult Phase 3 trial. The vaccine achieved noninferiority across all 28 serotypes it shares with Pfizer's Prevnar 20 (PCV20) and Merck's Capvaxive (PCV21) in adults aged 50 and older, and demonstrated superiority on three novel serotypes as well as serotype 20B. Safety was described as similar to both comparators, and the vaccine was well tolerated across age groups.

Two serotypes narrowly missed the greater-than-0.667 non-inferiority margin against PCV21, though both cleared the standard greater-than-0.5 threshold, a nuance analysts noted but did not view as a material setback, with some calling the overall result near best case. The broader 31-serotype coverage positions VAX-31 as a potentially differentiated option against established competitors in the pneumococcal vaccine market.

Vaxcyte said results from two additional adult Phase 3 trials, OPUS-2 and OPUS-3, are expected in the first half of 2027, with a U.S. Biologics License Application submission planned for the first half of 2028. Later on the same day, the company announced proposed public offerings totaling up to $1.15 billion: a $500 million offering of common stock and pre-funded warrants, a $500 million offering of convertible senior notes due 2032, and $150 million in combined over-allotment options across both legs.

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  1. BioStocks$PCVX Reports Positive Topline Data from OPUS-1, the Pivotal Adult Phase 3 Trial of VAX-31 VAX-31 Met All Prespecified Primary Endpoints Across Age Groups Studied Compared to Prevnar 20 (PCV20) and/or Capvaxive (PCV21)
  2. WallstengineVaxcyte $PCVX says VAX-31, its 31-valent pneumococcal vaccine, met all primary endpoints in pivotal adult Phase 3. It achieved noninferiority across all 32 serotype comparisons, with safety similar to PCV20/PCV21. OPUS-2/3 data due H1 2027.
  3. BriefingcomGapping up: $PCVX +56% $PTC +35.6% $ALEC +58% $RXO +21% Gapping down: $CHRW -9.7% $NIU -3.2% $VELO -2.5% $INSM -2.3%
  4. OpenOutcrier$PCVX (+57.2% pre) Vaxcyte shares surge as pneumococcal vaccine meets main trial goals
  5. BPharmCatalyst$PCVX reported positive Phase 3 OPUS-1 top-line data for VAX-31, a 31-valent pneumococcal conjugate candidate. The trial met primary safety, immunogenicity, and immunobridging endpoints versus PCV20 and PCV21, showing superiority on three novel serotypes and serotype 20B. Though two serotypes missed the >0.667 non-inferiority margin against PCV21, both met the standard >0.5 threshold. $ALVO $PBM $INSM $ALEC $PCVX $JAGX $QTEX $ARTV $NIVF $SBFM See More Pre-market Movers at BioPharmCatalyst in the Articles Menu
  6. Marketwirenews$PCVX - Vaxcyte Reports Positive Topline Data from OPUS1 the Pivotal Adult Phase 3 Trial of VAX31 the Companys 31Valent Pneumococcal Conjugate Vaccine Candidate VAX-31 Met All Prespecified Primary Endpoints Across Age Groups Studied Compared to Prevnar 20 ® (PCV20) and/or Capvaxive ® (PCV21) Prespecified Co-Primary Immunogenicity Endpoints: In Adults 50 and Older, All 28 VAX-31 Serotypes Shared with PCV20 and/or PCV21 Met Noninferiority... News & Disclaimer
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  8. MarketRebelsSTARTS NOW! Rebel's Edge 🏴‍☠️ 1pm Line up: #VIX $PTC $PCVX $NVDA $CHRW 🏈 NAJARIAN SPORTS 🏴‍☠️ with @petenajarian Brewers-Padres, Braves-Dodgers #ITSNOTANOPTION 📙
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  1. TheTradeXchange$PCVX - Commencement of Proposed Public Offerings of Common Stock, Pre-Funded Warrants and Convertible Senior Notes