STAT+: Pharmalittle: We’re reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more — SkimNews
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- Vaxcyte said its experimental pneumococcal vaccine VAX-31 met primary endpoints in a Phase 3 trial, setting up a head-to-head with established shots from Pfizer and Merck
- VAX-31 is designed to cover 31 serotypes of pneumococcal bacteria, compared with 20 strains targeted by Pfizer's Prevnar and 21 by Merck's Capvaxive
- Vaxcyte still must run two more trials before it can file for approval: one testing VAX-31 alongside an influenza vaccine and one in adults who previously received a different pneumococcal shot
- FDA extended its review of Novo Nordisk's experimental hemophilia A drug denecimig because of ongoing remediation work at a manufacturing facility
- Novo Nordisk submitted denecimig in September 2025 and had been expecting an FDA decision in the third quarter of 2026; the agency has not yet set a new timeline
- The FDA raised no concerns about denecimig's safety or efficacy data, and Novo said the manufacturing issues do not affect any of its other medicines on the market
Why it matters: Vaxcyte's broader serotype coverage (31 vs. 20-21 for incumbents) is the structural differentiator if the shot reaches market, giving it a shot at a pneumococcal vaccine space where Pfizer and Merck currently dominate. Separately, Novo Nordisk's denecimig delay is purely manufacturing-driven — not clinical — meaning the drug's commercial path is intact once the facility remediation clears, even though the timeline for hemophilia A patients just pushed past Q3 2026.
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