Vaxcyte Provides Positive Regulatory Updates on VAX-31 Pediatric and Adult Programs
Vaxcyte, Inc. (PCVX)
Company Research
Source: GlobeNewswire
-- VAX-31 Infant Indication: Investigational New Drug Application Cleared by FDA; Company Expects to Initiate VAX-31 Infant Phase 2 Study by the End of January 2025 -- -- VAX-31 Adult Indication: Breakthrough Therapy Designation Granted by FDA; Company Plans to Initiate Adult Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 -- -- VAX-31, Designed to Cover Currently Circulating and Historically Prevalent Strains, is Being Studied for the Prevention of Invasive Pneumococcal Disease in the Pediatric and Adult Populations -- SAN CARLOS, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today 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 designat
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PCVX
Earnings
- 11/5/24 - Beat
PCVX
Sec Filings
- 11/12/24 - Form SC
- 11/8/24 - Form 4
- 11/8/24 - Form 4
- PCVX's page on the SEC website