- Vaxcyte ( NASDAQ: PCVX ) on Thursday said the U.S. Food and Drug Administration (FDA) had granted a breakthrough therapy designation to its pneumococcal conjugate vaccine (PCV) candidate VAX-24.
- The company said the FDA's decision was based on results from an early-to-mid stage proof-of-concept study which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults aged 18 through 64 years.
- The PCV candidate is being developed for the prevention of invasive pneumococcal disease.
- The FDA's breakthrough therapy designation is a process meant to expedite the review of drugs that are intended for the treatment of serious diseases.
- PCVX expects topline safety, tolerability and immunogenicity data from a mid-stage study of VAX-24 in adults 65 and older in Q2 2023.
- Vaxcyte ( PCVX ) stock was slightly higher to $46.97 after the opening bell.
For further details see:
FDA grants breakthrough therapy designation to Vaxcyte's pneumococcal conjugate vaccine