Vaxcyte is developing VAX-31, a vaccine against 31 strains of pneumococcal bacteria for adults and infants; it is not approved, and Vaxcyte has no products on the market.
In OPUS-1, VAX-31 met every primary endpoint against Prevnar 20 and Capvaxive in 4,047 adults while covering 31 pneumococcal strains. Two strains, 3 and 12F, met only an older, looser bar against Capvaxive, a comparison Vaxcyte expects FDA to focus on. OPUS-2 and OPUS-3 report in the first half of 2027, then a lot-to-lot manufacturing study precedes a BLA planned for the first half of 2028. Cash of $2.5 billion at June 30 plus about $1.1 billion raised in October funds the program.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: OPUS-2 and OPUS-3 complete the adult data
Do OPUS-2 and OPUS-3 show VAX-31 is safe and immunogenic with a flu vaccine and in previously vaccinated adults?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
VAX-31 met its pivotal endpoints; OPUS-2 and OPUS-3 come next before a 2028 BLA
VAX-31's 31-valent pneumococcal vaccine thesis hinges on Phase 3 non-inferiority and superiority data against Prevnar 20 and Capvaxive
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Infectious diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
1 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.