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| Item | Status | Why it matters |
|---|---|---|
| IXCHIQ US license | Suspended 22 Aug 2025; BLA and IND withdrawn Jan 2026 | CBER cited chikungunya-like SAEs, including a vaccine-strain encephalitis death. US shipments stopped. Not a pause that automatically restarts. |
| IXCHIQ rest of world | Still labeled in EU, UK, Canada, Brazil (age bands differ) | FY 2025 sales €8.4M, including 40,000 doses to La Reunion. Branded travel, not Gavi scale after the SII license ended Dec 2025. |
| Serum Institute license | Mutually discontinued Dec 2025 | LMIC chikungunya volume moved toward Bavarian/SII Vimkunya. Q4 2025 included an €8.5M IXCHIQ inventory write-off. |
| VLA15 Lyme (Pfizer) | Phase 3 vaccination complete; first readout guided H1 2026 | Pfizer files if positive. Valneva eligible for $143M initial milestones, 14% to 22% royalties, and up to $100M sales milestones. |
| IXIARO / JESPECT | €98.4M in 2025 (+7.2% CER) | The cash cow. Japanese encephalitis, including a US DoD sole-supplier contract. This is the P&L while Lyme is still an option. |
Valneva is formed on 28 May 2013 by the merger of Intercell (IXIARO) and Vivalis. The commercial vaccines P&L starts here, not with IXCHIQ.
Pfizer licenses Valneva's Lyme candidate VLA15. If Phase 3 hits, Pfizer files; Valneva gets $143M in initial milestones, 14% to 22% royalties, and up to $100M in sales milestones.
Valneva lists ADSs on Nasdaq as VALN, alongside Euronext Paris VLA. The US listing is the ticker this roster uses.
FDA grants accelerated approval to IXCHIQ (live attenuated chikungunya) on 9 Nov 2023, the first licensed chikungunya vaccine. Adults 18+ at increased exposure risk.
FDA CBER suspends the IXCHIQ biologics license on 22 Aug 2025 after serious chikungunya-like adverse events, including a vaccine-strain encephalitis death. US shipments stop.
Valneva and Serum Institute mutually end the IXCHIQ license. Q4 2025 includes an €8.5M inventory write-off tied to that termination. Branded travel, not Gavi scale.
Valneva voluntarily withdraws the US BLA and IND for IXCHIQ after FDA places the IND on clinical hold. EU, UK, Canada, and Brazil labels remain the commercial path.
FY 2025 product sales €157.9M: IXIARO €98.4M, DUKORAL €31.9M, IXCHIQ €8.4M, third-party €19.2M. Proprietary products +9% CER. Lyme Phase 3 readout guided for H1 2026.