Vaxcyte provides regulatory updates on VAX-31 programs

Vaxcyte (PCVX) announced positive regulatory updates, including the United States Food and Drug Administration, FDA, clearance of the VAX-31 infant Investigational New Drug, IND, application and the FDA granting Breakthrough Therapy designation, BTD, for VAX-31 for the prevention of invasive pneumococcal disease, IPD, in adults. “Vaxcyte continues to maintain positive momentum with our PCV programs, and these regulatory milestones represent important steps in the development of VAX-31,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “The recent data from our adult Phase 1/2 study affirmed that VAX-31 has best-in-class potential, and we look forward to fully exploring its clinical utility in both the pediatric and adult populations. For the pediatric indication, we plan to initiate the VAX-31 infant Phase 2 study by the end of January 2025. For the adult indication, we look forward to moving VAX-31 into a Phase 3 program and plan to initiate the pivotal non-inferiority study by mid-2025.”