Vaxcyte (PCVX) tightened its timeline for Phase III data on its lead candidate VAX-31 during a presentation at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 9, 2026, now expecting results by the end of October rather than the broader fourth quarter.
The shift has heightened focus on the company’s pivotal non-inferiority trial, known as OPUS-1, which is testing a single-dose, high-dose formulation of the 31-valent vaccine against both Pfizer’s Prevnar 20 and Merck’s CAPVAXIVE in adult patients. Company guidance projects one missed endpoint versus Prevnar 20 and five misses versus CAPVAXIVE.
Grant Pickering, Vaxcyte’s CEO and founder, pushed back against strict non-inferiority benchmarks. "Perfection is not the price of admission in this class," he said, adding that regulators evaluate the "totality of the benefit." He characterized earlier clinical data as showing "unprecedented findings." To contextualize the threshold, Pickering pointed to Pfizer’s own approval trajectory: when Prevnar 20 was evaluated for infant use against Merck’s 15-valent standard of care, it had six failed non-inferiority comparisons yet still secured full licensure across all 20 serotypes.
Coverage breadth remains the central differentiator. VAX-31 covers approximately 95% of circulating pneumococcal disease serotypes — 10 more than Prevnar 20 and 11 more than CAPVAXIVE, which covers roughly 80%. Prevnar 20 covers about 60%.
In the adult segment, the market split in the most recent week cited showed Pfizer’s Prevnar 20 holding 52% share and Merck’s CAPVAXIVE at 48%, with Prevnar 20 extending its advantage in western U.S. states where serotypes 4 and 19F have reemerged. Mike Millett, Vaxcyte’s commercial lead, defended the company’s go-to-market approach. "Coverage is king," he said. "We're not going to 10,000 different customers across the U.S. We're really going to a few hundred customers."
A Phase II study in infants using VAX-31 is fully enrolled with 1,000 participants, with data expected in the first half of 2025. Meanwhile, Merck’s CAPVAXIVE has been building market presence over the prior 18 to 24 months.
The global pneumococcal vaccine class carries an estimated $8.5 billion annual run rate, with the adult segment alone projected at $2 billion to $3 billion.
Vaxcyte shares traded at $59.55 on the day of the conference, down 1.34% from a prior close of $60.36. The stock sits within a 52-week range of $30.81 to $65, well below Wall Street analysts’ price targets, which range from $67 to $163. The company’s market capitalization stands at approximately $8.87 billion.
Andrew Guggenhime, president and CFO, and Luis Jodar, medical affairs leader, also participated in the discussion. Cantor Fitzgerald analyst Carter Gould moderated the session.
