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| Period | Status | Why it matters |
|---|---|---|
| IXCHIQ US license | Suspended 22 Aug 2025. BLA and IND withdrawn Jan 2026 | CBER cited chikungunya-like SAEs. 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 €8.4 million, including 40,000 doses to La Reunion. H1 2026 sales €4.4 million, including initial drug-substance shipments to Instituto Butantan. Branded travel plus endemic pilots, not Gavi scale after the SII license ended Dec 2025. |
| Brazil PVS (H1 2026) | Approximately 50,000 adults vaccinated | First large-scale public campaign. Donation ceiling is up to 500,000 doses. Company is evaluating a shift toward endemic markets after weak travel uptake. |
| LB6V Lyme (Pfizer), formerly VLA15 | VALOR more than 70% efficacy. Filings planned | Primary statistical criterion missed on the first analysis (fewer cases). Second analysis met the bound. Valneva eligible for $143 million initial milestones, 14% to 22% royalties, and up to $100 million sales milestones if approved and commercialized. |
| IXIARO / JESPECT | €98.4 million in 2025. €44.0 million in H1 2026 | The cash cow. Japanese encephalitis, including a US DoD sole-supplier contract. H1 2026 was held back by Germany distributor transition and DoD shipment timing. This is the P&L while Lyme is still an option. |
| Period | Jurisdiction or mark | Printed status |
|---|---|---|
| 9 Nov 2023. US FDA approval | United States biologics license | Approved 9 Nov 2023 for adults 18 and older. License suspended 22 Aug 2025 after CBER cited chikungunya-like serious adverse events. BLA and IND withdrawn January 2026. Not a pause that automatically restarts. |
| 28 Jun 2024. EU marketing authorization | European Union | EMA marketing authorization 28 Jun 2024. Adolescent label extension (12 years and older) granted April 2025. Still labeled as of H1 2026. |
| 24 Jun 2024. Health Canada approval | Canada | Approved 24 Jun 2024 for adults 18 and older. Still labeled as of H1 2026. |
| 5 Feb 2025. UK MHRA approval | United Kingdom | MHRA marketing authorization 5 Feb 2025 for adults 18 and older. Still labeled as of H1 2026. |
| 14 Apr 2025. Brazil ANVISA approval | Brazil (endemic) | First endemic-country marketing authorization, 14 Apr 2025, ages 18 and older. ANVISA authorized Instituto Butantan local manufacture in May 2026. PVS ages 18 to 59. |
| Apr 2025. La Reunion outbreak supply | France (La Reunion) | 40,000 doses supplied starting early April 2025, paid for by French authorities, with an option to provide more. H1 2025 and H1 2026 PRs treat this as non-recurring outbreak volume. |
| H1 2026. Brazil PVS doses (approx.) | Brazil Pilot Vaccination Strategy | Approximately 50,000 adults aged 18 to 59 vaccinated as of the H1 2026 print (Q1 2026 print: over 30,000). Floor/approximate, not an exact census. Valneva committed to donate up to 500,000 doses (ceiling, not delivered count). |
| Period | Mark | Printed amount or status |
|---|---|---|
| Collaboration. Initial commercialization milestones | Pfizer Lyme collaboration | $143 million of initial (early commercialization) milestones. Printed as not in the IFRS transaction price until they occur. Not earned as of H1 2026. |
| Collaboration. Royalties | Valneva royalties on Pfizer sales | 14% to 22% of sales if the product is approved and commercialized. Rate band, not a current royalty dollar print. |
| Collaboration. Sales milestones | Cumulative sales milestones | Up to $100 million. Printed as not in the transaction price until they occur. |
| 23 Mar 2026. VALOR primary analysis | Phase 3 field efficacy, 28 days post-dose 4 (season 2) | 73.2% reduction in confirmed Lyme disease versus placebo (95% CI 15.8, 93.5). Pre-determined criterion (lower bound above 20) was not met because fewer cases accrued than anticipated. |
| 23 Mar 2026. VALOR second pre-specified analysis | Phase 3 field efficacy, 1 day post-dose 4 (season 2) | 74.8% (95% CI 21.7, 93.9). Lower bound above 20. Pfizer described the result as clinically meaningful and is planning submissions. |
| H1 2026. Regulatory path (outlook) | US BLA and EU MAA | Pfizer engaging regulators on pathways to licensure. H1 2026 print: regulatory decisions expected in the next twelve months. Fast Track (FDA) and PRIME (EMA). Outlook, not an approval. |
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.