Vaxcyte’s Pneumococcal Vaccine Shows Promise in Phase 3 Trial

Vaxcyte has reported promising results from a Phase 3 clinical trial for its experimental pneumococcal vaccine, VAX-31. The trial met its primary endpoints, setting the stage for a competitive showdown with Pfizer and Merck. VAX-31 is designed to protect against 31 serotypes of the bacteria causing pneumococcal disease, including pneumonia, compared to 20 strains for Pfizer’s Prevnar and 21 strains for Merck’s Capvaxive. However, Vaxcyte still needs to complete two additional trials before seeking regulatory approval: one evaluating VAX-31 alongside an influenza vaccine and another in adults who previously received a different pneumococcal shot.

The U.S. Food and Drug Administration (FDA) has extended its review of Novo Nordisk’s experimental hemophilia A drug, denecimig. The delay stems from ongoing remediation work at a manufacturing facility. Novo Nordisk had submitted the application for denecimig in September 2025 and was anticipating an FDA decision in the third quarter of 2026. While the FDA has not yet provided a new timeline, Novo Nordisk assured that the regulator raised no concerns regarding the safety or effectiveness data from the drug’s clinical trials. The company also noted that the manufacturing issues do not impact any of its other medicines currently on the market.