- Trial Phase
- Authorized (EUA)
- Time to Market
- Already on market under EUA since March 2024. EUA terminates June 29, 2027 unless converted to full BLA approval. BLA pathway being explored.
- Why 4/10
- PEMGARDA is already commercialized under EUA (granted March 2024) with no pending PDUFA or pivotal readout for itself. The July 6, 2026 FDA Notice of Termination (effective June 29, 2027) creates a known 12-month overhang but is not a binary catalyst. The next hard catalysts are VYD2311 Phase 3 data (Q3 2026), which is a different drug. Score 4: approved/authorized drug with no imminent binary for itself.
The EUA termination notice (effective June 2027) puts a clock on PEMGARDA's revenue stream and makes BLA conversion or VYD2311 success existential for Invivyd. Watch for VYD2311 Phase 3 LIBERTY/DECLARATION topline data expected Q3 2026 — that will be the next major price catalyst, not a PEMGARDA event. The stock has substantial institutional support but faces significant regulatory overhang.
Price Chart
Executive Summary
PEMGARDA (pemivibart) is Invivyd's only commercialized product — a monoclonal antibody authorized under FDA Emergency Use Authorization since March 2024 for preventing COVID-19 in immunocompromised people who don't respond well to vaccines. It generated ~$53.4M in revenue in FY2025 and ~$13.7M in Q1 2026 (+22% YoY). However, on July 6, 2026, Invivyd announced the FDA issued a Notice of EUA Termination effective June 29, 2027, following HHS's broader COVID-19 EUA declaration wind-down. Invivyd says it is in dialogue with FDA and plans to pursue a Biologics License Application (BLA) for full approval. The EUA termination creates a ~12-month clock on PEMGARDA's revenue. The company's future increasingly depends on its next-generation candidate VYD2311 (Phase 3 data due Q3 2026), which has an FDA-aligned rapid BLA pathway.
How It Works
PEMGARDA is an injected monoclonal antibody — a manufactured protein designed to stick to the spike protein of the SARS-CoV-2 virus (which causes COVID-19) and block it from entering human cells. It acts like a temporary, man-made immune system for people whose own immune systems don't produce enough protection from vaccines. It is given as a one-hour IV infusion and provides protection for roughly 3 months before another dose is needed.
Trial Status
PEMGARDA received FDA Emergency Use Authorization on March 22, 2024 for pre-exposure prophylaxis of COVID-19 in immunocompromised adults/adolescents. Supported by Phase 3 CANOPY trial and immunobridging data from parent antibody adintrevimab. On July 6, 2026, the FDA sent a Notice of Termination effective June 29, 2027 (12-month transition). Invivyd is in dialogue with FDA about next steps and pursuing BLA conversion. The company's next-gen candidate VYD2311 is in active Phase 3 trials (LIBERTY and DECLARATION) with data expected Q3 2026.
The Two-Sided Case
Upcoming Catalysts
- VYD2311 Phase 3 LIBERTY trial topline data (Q3 2026) — the next major catalyst for the stock
- VYD2311 Phase 3 DECLARATION placebo-controlled efficacy data — timeline TBD but likely H2 2026
- Potential BLA submission for PEMGARDA or VYD2311 — timeline unclear
- Q2 2026 earnings report — revenue growth trajectory update (estimated ~$14-16M)
- EUA termination effective June 29, 2027 — ongoing FDA dialogue about BLA pathway
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Invivyd, Inc. 8-K IVVD ·Originating report