regulatory
confidence high
sentiment positive
materiality 0.85
Invivyd aligns with FDA on rapid BLA pathway for VYD2311; Q2 revenue $11.8M, up 413% YoY
Invivyd, Inc.
- Q2 2025 PEMGARDA net product revenue $11.8M, up 413% YoY; net loss $14.7M ($0.12/sh) vs $47.2M ($0.40/sh) in Q2 2024.
- Cash and cash equivalents $34.9M as of June 30, 2025; near-term profitability target not met but possible with upcoming season.
- FDA alignment on rapid BLA pathway for VYD2311; single Phase 2/3 trial with 12-week primary endpoint may support approval for COVID-19 prevention.
- Pipeline expansion: RSV candidate identification expected Q3 2025, measles candidate by end of 2025.
- VYD2311 safety data: 76-day half-life IM, attractive profile; quantities of commercial launch product available.
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