STAT+: Pharmalittle: We’re reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more
Vaxcyte said its pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up a competition with Pfizer and Merck
Good morning, everyone, and welcome to another work week. The weekend respite was meant to be relaxing and invigorating, but now the familiar routine of meetings and deadlines has returned. The world continues to spin, and we rely on our daily cup of blueberry hibiscus to stimulate us. Now, let's dive into some interesting news items.
Vaxcyte made headlines by announcing that its experimental pneumococcal vaccine, VAX-31, reached the primary endpoints in a Phase 3 clinical trial. This new vaccine aims to protect against 31 serotypes of bacteria that can cause pneumococcal disease, surpassing Pfizer's Prevnar, which covers 20 strains, and Merck's Capvaxive, which covers 21 strains.
However, Vaxcyte still needs two more trials before filing for approval. These trials will involve administering VAX-31 alongside an influenza vaccine and assessing its effectiveness in adults who have previously received a different pneumococcal shot.
Meanwhile, Novo Nordisk's experimental hemophilia A drug, denecimig, has faced a delay in the FDA's review process due to ongoing remediation work at a manufacturing facility. Novo Nordisk submitted the application for denecimig in September 2025 and was expecting a decision in the third quarter of 2026. However, the FDA has not yet announced a new timeline for its decision.
Despite the delays, Novo Nordisk assured that the manufacturing site issues do not impact any of its other medicines currently available on the market.
Written by urgent.news from STAT News's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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