PCVX ~+55%: Vaxcyte VAX-31 hits all primary endpoints in Phase 3 OPUS-1 vs Prevnar 20/Capvaxive — PFE/MRK read

[LondonNewsTrader]

Biggest mid/large-cap gap of the day: Vaxcyte (PCVX) reported topline data from OPUS-1, the pivotal adult Phase 3 for VAX-31, its 31-valent pneumococcal conjugate vaccine. It met all prespecified primary immunogenicity endpoints in adults 50+: non-inferior on 20 of 20 serotypes shared with Pfizer's Prevnar 20, and 17 of 19 shared with Merck's Capvaxive (PCV21). The two misses vs Capvaxive (serotypes 3 and 12F) still cleared the older, lower historical bar. Safety looked similar to the approved shots, and the 18–49 immunobridging endpoint was met on all 32 comparisons.

Shares were around $88 (~+55%) per Benzinga, from about $56 on Friday — so roughly a $12B company now. Timeline matters for the multi-week view: OPUS-2 and OPUS-3 read out 1H 2027 and the BLA is planned for 1H 2028, so this is a de-risking event, not a near-term revenue story. The company itself flags the Capvaxive comparison as a likely FDA focus.

Scalper read: biotech gaps of this size on clean data often hold the opening range better than gaps on mixed data, but the first pullback toward VWAP is where you find out whether institutions are adding. Worth watching PFE and MRK for any sympathy weakness given this targets their franchises.

Sources (public): Vaxcyte press release and 8-K, 5 Oct; Fierce Biotech; Benzinga movers, Mon 5 Oct.

Anyone trading PCVX off VWAP today, or is a +55% biotech gap a no-touch for you? Do you see any real pressure on PFE/MRK from this yet?