NasdaqGS:PCVXBiotechs
Is FDA’s Expanded Breakthrough Designation and Optimized Dosing Arm Shifting the Investment Case for Vaxcyte (PCVX)?
Vaxcyte recently announced the advancement of its modified VAX-31 infant Phase 2 study to the third and final stage, aiming to deliver key safety and immunogenicity data by mid-2027, and the inclusion of an optimized dosing arm while enrollment in the low dose arm is discontinued.
The FDA has expanded the Breakthrough Therapy designation for VAX-31, underlining regulatory enthusiasm for Vaxcyte’s broadest-spectrum pneumococcal conjugate vaccine candidate targeting serious infections in...