Valneva SE
VALN evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for VALN—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · VALN
Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, with a late-stage pipeline including a Lyme disease vaccine candidate partnered with Pfizer and a marketed chikungunya vaccine (IXCHIQ).
Key risk: Lyme vaccine Phase 3 data risk
BioSniper Score
Based on 2 of 6 signals
Limited data coverage
Financial data as of Dec 31, 2025.
Tracking 396 clinical trials · 23 catalysts for Valneva SE.
Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, with a late-stage pipeline including a Lyme disease vaccine candidate partnered with Pfizer and a marketed chikungunya vaccine (IXCHIQ).
- Valneva's pipeline includes a Lyme disease vaccine candidate (LB6V) partnered with Pfizer, with marketing applications expected to be submitted by Pfizer in H2 2026 [sec · filed 2026-08-13].
- The company has a marketed chikungunya vaccine (IXCHIQ), but revenue expectations were not met in 2025 due to reports of serious adverse events and subsequent regulatory action [sec · filed 2026-03-17].
- As of December 31, 2025, Valneva had an accumulated net loss of €679.1 million and cash & equivalents of $109.7M (as of 2025-12-31) [sec · filed 2026-03-17].
- Valneva's manufacturing infrastructure includes BioSafety Level 3 (BSL-3) facilities in Europe, and the company has strategic partnerships with large pharmaceutical firms to leverage clinical and commercial capabilities [sec · filed 2026-03-17].
- The company expects to fund 2026 capital expenditures primarily from existing cash and cash equivalents [sec · filed 2026-03-17].
What works
- Valneva has a validated product development platform and a track record of advancing vaccine candidates from clinic to commercialization, supported by a team with experience at Novartis, GSK, and other industry leaders [sec · filed 2026-03-17].
- The company has entered into strategic partnerships with well-established pharmaceutical companies to optimize the potential value of select assets, including Pfizer for the Lyme disease vaccine candidate [sec · filed 2026-03-17].
- Valneva's manufacturing infrastructure includes BSL-3 facilities, providing in-house capability for clinical and commercial production [sec · filed 2026-03-17].
What to weigh
- Valneva has a history of significant net losses and an accumulated net loss of €679.1 million as of December 31, 2025, and may not achieve or maintain profitability over the next several years [sec · filed 2026-03-17].
- The company's business is capital intensive, and it may need to raise additional capital to fund development and commercialization; negative Phase 3 data for the Lyme disease vaccine could trigger restructuring obligations and a default under its Pharmakon loan [sec · filed 2026-03-17].
- Revenue from IXCHIQ was below expectations in 2025 due to serious adverse event reports and regulatory action, highlighting commercial risk even after approval [sec · filed 2026-03-17].
- Delays in clinical development or regulatory approvals could adversely affect expected commercial timelines and royalty revenues, particularly for the Lyme disease vaccine candidate [sec · filed 2026-03-17].
From the filings
Quoted directly from source documents.
Valneva has an accumulated net loss of €679.1 million as of December 31, 2025.
“As of December 31, 2025, we had an accumulated net loss of €679.1 million.”
SEC filings · March 17, 2026
Pfizer will submit marketing applications for the Lyme disease vaccine candidate LB6V in H2 2026.
“Submission by Valneva's partner, Pfizer, of marketing applications for Lyme disease vaccine candidate LB6V”
SEC filings · August 13, 2026
IXCHIQ revenue was below expectations in 2025 due to serious adverse events and regulatory action.
“we did not generate expected revenue from sales of IXCHIQ in 2025 due to reports of serious adverse events ("SAEs") and subsequent regulatory action.”
SEC filings · March 17, 2026
Negative Phase 3 data for the Lyme disease vaccine could trigger restructuring and a loan default.
“This is particularly in the event of negative Phase 3 data for our Lyme disease vaccine candidate. Additionally, the terms of our existing financing arrangements place restrictions on our operating and financial flexibility and in the event of negative data for our Lyme disease vaccine candidate, we may be required by law to initiate restructuring processes that would constitute an event of default under our loan from Pharmakon.”
SEC filings · March 17, 2026
Catalyst timeline
- 2026-12-04 · Phase3_Topline — Phase 3 Topline: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study With Ex — Topline data from a Phase 3 study; specific indication not detailed in the provided chunks.
- 2026-12-17 · Phase3_Topline — Phase 3 Topline: A Phase 3, Multicenter, Randomized, Open-label, Controlled Study to Investigate the Efficacy and Saf — Topline data from a Phase 3 study; specific indication not detailed in the provided chunks.
- 2026-12-31 · Phase3_Topline — Phase 3 Topline: NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlle — Topline data from a Phase 3 study; specific indication not detailed in the provided chunks.
- 2027-02-01 · Phase3_Topline — Phase 3 Topline: Determine the Efficacy of Investigational Drug QRX-3 in Hospitalized Patients With Acute Tubular Nec — Topline data from a Phase 3 study; specific indication not detailed in the provided chunks.
- 2027-07-01 · Phase3_Topline · baricitinib — Phase 3 Topline: Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and — Topline data from a Phase 3 study evaluating baricitinib; specific indication not detailed in the provided chunks.
- 2027-07-30 · Phase3_Topline · nerandomilast — Phase 3 Topline: A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomi — Topline data from a Phase 3 study evaluating nerandomilast; specific indication not detailed in the provided chunks.
- 2027-11-01 · Phase3_Topline — Phase 3 Topline: A Multicenter, Randomized, Controlled, Double-blind Pivotal Phase 3 Trial to Evaluate the Safety and — Topline data from a pivotal Phase 3 study; specific indication not detailed in the provided chunks.
- 2028-01-02 · Phase3_Topline — Phase 3 Topline: A Phase III, Randomized, Double-blinded, Active-controlled, Multinational, Multicenter Study to Asse — Topline data from a Phase 3 study; specific indication not detailed in the provided chunks.
Risks & what to watch (4)›
Key risks
- Lyme vaccine Phase 3 data risk — Negative Phase 3 data for the Lyme disease vaccine candidate could trigger restructuring and a default under the Pharmakon loan [sec · filed 2026-03-17].
- Capital needs and profitability — Valneva has an accumulated net loss of €679.1M and may need additional capital; the business is capital intensive [sec · filed 2026-03-17].
- IXCHIQ commercial setback — Revenue from IXCHIQ was below expectations in 2025 due to serious adverse events and regulatory action [sec · filed 2026-03-17].
- Regulatory and clinical delays — Delays in clinical development or regulatory approvals could harm commercial timelines and royalty revenues [sec · filed 2026-03-17].
What to watch
- Pfizer's submission of marketing applications for the Lyme disease vaccine candidate LB6V in H2 2026 [sec · filed 2026-08-13].
- Phase 2 data reporting for the Shigella vaccine candidate S4V2 (CHIM and infant studies) in H2 2026 [sec · filed 2026-08-13].
- Regulatory developments for IXCHIQ in new markets and any impact from the 2025 SAE-related regulatory action [sec · filed 2026-03-17].
- Valneva's ability to manage cash runway and avoid triggering restructuring covenants tied to the Pharmakon loan [sec · filed 2026-03-17].
Sources: SEC filings · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 2 of 6 signals · derived from public data
No clinical pipeline tracked — this score reflects financial & catalyst signals only.
Cash runway data unavailable
D/E 2.76
No tracked pipeline phase
No tracked pipeline candidates
23 upcoming, next in ~96d
No insider transactions in the last 180 days
Catalysts
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
19
Total value held
$10.0M
| Holder | Shares | Value |
|---|---|---|
| novo holdings a/s | 1,057,421 | $6.6M |
| general american investors co inc | 354,361 | $2.2M |
| wells fargo & company/mn | 78,029 | $488K |
| morgan stanley | 46,925 | $293K |
| ironwood investment management llc | 25,135 | $157K |
| old mission capital llc | 13,759 | $86K |
| vsm wealth advisory, llc | 10,000 | $63K |
| rhumbline advisers | 1,793 | $11K |
| gamma investing llc | 1,426 | $9K |
| steigerwald, gordon & koch inc. | 1,250 | $8K |
Showing top 10 of 19 institutional holders of Valneva SE. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 0.2%
- Days to cover
- 1.3
- Shares short
- 152,470
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
VALN short interestFrequently asked questions
What is the AI investment thesis for Valneva SE?
Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, with a late-stage pipeline including a Lyme disease vaccine candidate partnered with Pfizer and a marketed chikungunya vaccine (IXCHIQ).
What is Valneva SE's next catalyst?
Valneva SE's next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study With Ex" — expected December 4, 2026.
Who is the CEO of Valneva SE?
Mr. Thomas Lingelbach is the chief executive officer of Valneva SE (VALN).
Where is Valneva SE headquartered?
Valneva SE (VALN) is headquartered in Saint-Herblain, France.
What therapeutic areas does Valneva SE focus on?
Valneva SE develops therapies across Oncology, Rare Disease, Gene Therapy, Neurology, Immunology, Ophthalmology, Cardiovascular, Infectious Disease, Metabolic, Respiratory, Pain, Dermatology, Nephrology, Musculoskeletal, Gastroenterology, Endocrinology, Reproductive, Psychiatry.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.