Vaxcyte Provides Positive Regulatory Updates on VAX-31 Pediatric and Adult Programs
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Vaxcyte announced positive regulatory updates for its VAX-31 programs. The FDA cleared the Investigational New Drug Application for the VAX-31 infant indication, with a Phase 2 study expected by January 2025. Additionally, the VAX-31 adult indication received Breakthrough Therapy Designation, with a Phase 3 study planned for mid-2025.
November 12, 2024 | 12:45 pm
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Vaxcyte's VAX-31 programs received significant regulatory approvals from the FDA. The infant indication's Investigational New Drug Application was cleared, and the adult indication was granted Breakthrough Therapy Designation. These updates are likely to positively impact Vaxcyte's stock.
The FDA's clearance of the Investigational New Drug Application for the VAX-31 infant indication and the Breakthrough Therapy Designation for the adult indication are significant regulatory milestones. These approvals suggest potential for successful clinical trials and future market opportunities, likely boosting investor confidence and positively impacting Vaxcyte's stock price.
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