Key Takeaways
- Vaxcyte shares are up about 36% after its VAX-31 pneumococcal vaccine met every primary goal in OPUS-1, its pivotal adult Phase 3 trial.
- VAX-31 cleared a stricter-than-usual bar against Pfizer’s Prevnar 20 on all 20 shared strains, but on only 17 of 19 against Merck’s Capvaxive.
- Management expects the FDA to focus on the Capvaxive comparison, and Vaxcyte’s free cash flow was -$713 million in 2025 with no product on the market.
- OPUS-2 and OPUS-3 results come in the first half of 2027, and the FDA filing is planned for the first half of 2028.
Vaxcyte (PCVX) shares are up about 36% today. Before Monday’s open, the company said VAX-31, its 31-valent pneumococcal vaccine, met every primary goal in OPUS-1, its pivotal adult Phase 3 trial.
What exactly happened
These vaccines are judged strain by strain (“serotypes,” in the jargon), and VAX-31 covers 31 of them. In adults 50 and older:
- All 28 serotypes shared with Prevnar 20, from Pfizer (PFE), and/or Capvaxive (PCV21), from Merck (MRK), met the trial’s noninferiority bar against at least one of the two.
- The three serotypes only VAX-31 covers, plus the related serotype 20B, cleared a much higher superiority bar.
- Safety was similar to both rivals.
CEO Grant Pickering said VAX-31 “sets a new benchmark for the class and gives us confidence in its potential for approval.”
The fine print
Even at the low end of the statistical range, VAX-31’s immune response had to reach two-thirds of the rival’s.
Tested against each rival separately, VAX-31 cleared that bar on 20 of 20 serotypes shared with Prevnar 20, but on “only” 17 of 19 shared with Capvaxive.
Chief Scientific Officer James Wassil made clear that the Capvaxive comparison is the one that counts most:
“Given current U.S. epidemiology, with the serotypes unique to PCV21 accounting for a larger share of adult disease, we expect the comparison of VAX-31 to PCV21 to be a particular focus of FDA review.”
What’s next
OPUS-2 and OPUS-3 report in the first half of 2027, and Vaxcyte plans to file with the FDA in the first half of 2028. Until then, it lives on the cash it has built up…
Counting longer-dated investments too, it had about $2.5 billion at the end of June.
It’s also burning cash faster every year: free cash flow went from -$128 million in 2021 to -$713 million in 2025…
…so we shouldn’t be surprised to see a capital raise in the near future. (Dilution stinks, but running out of money when you have a great drug candidate on your hands is far worse.)
The upshot
Vaxcyte expects the pneumococcal vaccine market to grow from $8.5 billion in sales last year to about $12 billion by 2030. It also says VAX-31 could cover about 95% of invasive pneumococcal disease in U.S. adults 50 and older.
Two more Phase 3 readouts and the FDA still stand between Vaxcyte and its (potential) first sale. But if the data remains this encouraging, it’s not hard to see Vaxcyte scooping up some percentage of that and providing a real challenge to Pfizer and Merck’s established drugs.
So what is Vaxcyte stock actually worth?
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Disclaimer:
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