| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
BLA Submission example | BLA | — | Subscribe to access the data. | Vaccines | Infectious Diseases | ||
BLA Submission example | BLA | — | Subscribe to access the data. | Vaccines | Infectious Diseases | ||
BLA Submission example | BLA | — | Subscribe to access the data. | Vaccines | Infectious Diseases |
Recent Updates
Recently added Catalysts
Valneva SE$5.05
-0.25 (-4.63%)
C 55Pipeline Score Fair Value Biotech · Clinical
Market Cap
544.48 M
EPS
-1.87
P/E Ratio
-
Value Trade
85.57 K
1.89 %
Week
5.7 %
1 Month
-46.82 %
3 Month
-31.92 %
6 Month
-79.19 %
5 Year
-78.09 %
All Time
Cash Data
Cash Position
12.35 K
Monthly Burn
12.35 K
Runway
12,345 mo
Overview
Volume
16.12 K
52 Week Range
5.06 - 12.25
% held by Insiders
4.74 %
% held by Institutions
0.59 %
Enterprise Value
664.58 M
Total Shares
94.82 M
Short %
0.19 %
Float Shares
89.87 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Valneva SE
498Total events
10Upcoming
204Tier-1 (high impact)
2015 – 2028Coverage
Upcoming catalysts 10
Q3 2027
T2Product Launch
Pfizer plans to commercialize VLA15 in second half of 2027, subject to regulatory approvals
Mar 31, 2028
T2Equity Offering
Potential exercise of warrants for up to €47 million additional proceeds
TBD
T2Trial Initiation
Planned initiation of Phase 3 pediatric study after additional real-world data in adolescents
Event history 488
Jun 3, 2026
◆Oral PresentationPresentation
10th Northern European Conference on Travel Medicine (NECTM10) participation
Jun 3, 2026
◆Poster PresentationPresentation
10th Northern European Conference on Travel Medicine (NECTM10) Gold Sponsor and Exhibitor
Jun 2026
◆Topline ReadoutS4V2Clinical Data
First Phase 2 data for tetravalent Shigella vaccine candidate S4V2
Shigellosissource ↗
May 28, 2026
▲Topline ReadoutLB6VClinical Data
Pfizer reported topline Phase 3 results for LB6V demonstrating strong efficacy with no safety concerns
Lyme diseasesource ↗
May 18, 2026
May 2026
▲Other Regulator MilestoneIXCHIQDiscontinuedEx-US Regulatory
ANVISA authorized Instituto Butantan to locally manufacture a version of IXCHIQ
Chikungunyasource ↗
Apr 30, 2026
Apr 30, 2026
▼Restructuring LayoffsCorporate
Initiated further restructuring plan including workforce reduction
Drug Pipeline Intelligence
C55
Pipeline Score $1.6B
Pipeline ValueFair Value
Valuation Signal15
Drugs Scored3.0x
rNPV / MCap Top 83%
Micro Cap (rank 156 of 911)
Percentile RankValneva SE carries a moderate pipeline score (55/100), with $6.2B risk-adjusted pipeline value, led by VLA2001 in SARS-CoV-2 Infection (Phase 2), across $86B in total addressable markets.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VLA2001 Monoclonal antibody | SARS-CoV-2 Virus Infection | Phase 3 | NCT04671017 | 65% | $3.4B | COMPLETED | 4,493 | - | - | Apr 6, 2022 | - | Apr 22, 2022 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
LB6V | Lyme Disease | Phase 3 | 2026-05-28 | strong efficacy with no safety concerns | Valneva to Participate at U.S. and European Investor Conferences in June Read More | |
LB6V | Lyme Disease | Phase 3 | 2026-05-28 | strong efficacy with no safety concerns | Valneva to Participate at U.S. and European Investor Conferences in June Read More | |
LB6V | Lyme Disease | Phase 3 | 2026-05-28 | strong efficacy with no safety concerns | Valneva to Participate at U.S. and European Investor Conferences in June Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in VALN
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
VALN Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
VALNValneva Announces Successful Outcome of its Annual General Meeting
Valneva SE successfully held its Annual General Meeting in Lyon, where shareholders approved all proposed resolutions. Key decisions included the approval of financial statements and the reappointment of several board members. Dr. Gerd Zettlmeissl was appointed as the new Chair of the Board, succeeding Anne-Marie Graffin, who will continue as Vice-chair.
Read more →VALNMaking Sustainability Durable: Why Governance Matters in Healthcare
Valneva's Director of Finance Excellence discusses the importance of integrating sustainability into healthcare governance. The company's sustainability strategy focuses on protecting lives, preserving the planet, and reaching people. Valneva aims to embed sustainability into decision-making processes, emphasizing the role of vaccines in public health and the need for collaboration to address emerging health challenges.
Read more →VALNValneva annonce la mise à disposition de la documentation relative à son Assemblée Générale annuelle
Valneva SE has announced the availability of documentation for its annual general meeting (AGM) scheduled for June 25, 2026. The notice includes the agenda, proposed resolutions, and instructions for participation. Shareholders are encouraged to consult the documents online or request them via email. Valneva specializes in developing vaccines for infectious diseases.
Read more →VALNValneva Announces Availability of Documentation for its Annual General Meeting
Valneva SE has announced the availability of documentation for its Annual General Meeting scheduled for June 25, 2026. Shareholders can access the preliminary notice, agenda, and draft resolutions online or request them via email. The company emphasizes its commitment to transparency and shareholder engagement.
Read more →VALNVALNEVA:Declaration of shares and voting rights - Status as of May 31, 2026
Valneva has issued a declaration regarding its shares and voting rights as of May 31, 2026. The declaration was made on June 3, 2026, and includes details about theoretical and net voting rights. This information is relevant for shareholders and stakeholders in understanding the company's governance structure.
Read more →VALNValneva to Participate at U.S. and European Investor Conferences in June
Valneva SE announced its participation in several investor conferences in June 2026, including the Jefferies Global Healthcare Conference and the Oddo BHF Nextcap Forum. Key discussions will focus on Valneva's commercial stage vaccines, particularly the Lyme Disease vaccine candidate LB6V, which has shown promising Phase 3 results. The company will also engage with medical professionals at the Northern European Conference on Travel Medicine.
Read more →VALNValneva annonce sa participation à des conférences investisseurs aux États-Unis et en Europe
Valneva SE has announced its participation in several investor conferences in June 2026, both in the United States and Europe. Key topics will include their commercial vaccines and the advanced Lyme disease vaccine candidate, LB6V, which has shown strong efficacy in Phase 3 trials. The company invites institutional investors to connect with them during these events.
Read more →VALNValneva publie ses résultats financiers audités et consolidés pour le premier trimestre 2026
Valneva SE reported its audited financial results for Q1 2026, revealing a total revenue of €30.9 million, a significant decline from €49.2 million in Q1 2025. The company has adjusted its sales forecasts for 2026 due to unfavorable trends in vaccine adoption linked to geopolitical factors. Despite a strong cash position of €105.3 million, Valneva faces challenges with increased net losses and reduced sales from third-party products.
Read more →VALNValneva Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Valneva SE reported its financial results for Q1 2026, showing total revenues of €30.9 million, a significant decline from €49.2 million in the same quarter of 2025. The company also experienced an increased net loss of €32.1 million due to various operational challenges. In response, Valneva is implementing cost-saving measures and adjusting its sales guidance for the year. The company remains focused on its proprietary vaccine products and strategic initiatives.
Read more →VALNValneva publiera ses résultats financiers consolidés du premier trimestre le 13 mai 2026
Valneva SE announced it will release its consolidated financial results for Q1 on May 13, 2026. A live web conference will follow at 15:00 CET, where the company will discuss its results and business activities. Valneva specializes in developing vaccines for infectious diseases and has a strong R&D track record.
Read more →VALNValneva to Report First Quarter 2026 Consolidated Financial Results on May 13, 2026
Valneva SE announced it will report its first quarter 2026 financial results on May 13, 2026. A live webcast will be hosted to discuss these results and provide a business update. The company focuses on developing vaccines for infectious diseases and has a strong pipeline, including a Lyme disease vaccine candidate partnered with Pfizer.
Read more →VALNVALNEVA: Declaration of shares and voting rights - Status as of April 30, 2026 taking into account interim information as at May 5, 2026
Valneva has issued a declaration regarding its shares and voting rights as of April 30, 2026, with interim information updated as of May 5, 2026. The declaration includes details about the theoretical and net voting rights associated with the company's shares. This information is crucial for understanding shareholder voting power and compliance with regulatory requirements.
Read more →VALNValneva publiera ses résultats financiers consolidés du premier semestre le 13 mai 2026
Valneva SE has announced it will publish its consolidated financial results for the first half of 2026 on May 13, 2026. A live web conference will follow, where the company will discuss its results and ongoing activities. Valneva specializes in developing vaccines for infectious diseases and currently markets three travel vaccines.
Read more →VALNValneva to Report First Quarter 2026 Consolidated Financial Results on May 13, 2026
Valneva SE has announced it will report its first quarter 2026 financial results on May 13, 2026. The company will host a live webcast to discuss these results and provide a business update. Valneva specializes in developing vaccines for infectious diseases and has a strong pipeline, including a Lyme disease vaccine candidate.
Read more →VALNWhy Prevention Must be at the Center of the Lyme Disease Response
The article discusses the urgent need for a prevention-focused approach to Lyme disease, which is increasingly prevalent and under-recognized. It highlights the complexities of developing vaccines and the importance of public awareness and research. As Lyme disease cases rise due to environmental changes, a shift in perspective towards prevention is deemed essential to mitigate its impact on individuals and healthcare systems.
Read more →VALNValneva Announces the Successful Completion of an €84 million Reserved Offering
Valneva SE has successfully completed a reserved offering, raising €84 million to support its vaccine pipeline and general corporate purposes. The offering attracted both existing and new investors, with a closing date set for May 5, 2026. The funds will be allocated equally between advancing vaccine candidates and working capital needs.
Read more →VALNValneva annonce le succès d’une Offre Réservée d’un montant de 84 millions d’euros
Valneva SE has successfully completed a reserved offering amounting to €84 million, involving both existing and new investors. The funds will be allocated to advance its vaccine portfolio and support general operational needs. The offering includes the issuance of new shares and warrants, with the settlement expected on May 5, 2026.
Read more →VALNOpportunities and Challenges of Being a Dual-Listed Company
Valneva's CFO, Peter Bühler, discusses the dual listing of the company on Euronext and NASDAQ, highlighting both the opportunities for increased visibility and challenges in regulatory compliance. The dual listing enhances investor engagement, particularly in the US, while also requiring adherence to complex regulations like the Sarbanes-Oxley Act. Bühler emphasizes the importance of balancing financial responsibility with innovation in vaccine development.
Read more →VALNValneva to Participate in Multiple Events at the 26th World Vaccine Congress in Washington DC
Valneva SE will participate in the 26th World Vaccine Congress in Washington, D.C., from March 31 to April 2, 2026. CEO Thomas Lingelbach and senior executives will present updates on their chikungunya vaccine, IXCHIQ®, which is undergoing a pilot vaccination campaign in Brazil. The event will also feature discussions on vaccine development and partnership opportunities.
Read more →VALNValneva participera à plusieurs événements lors du 25ème World Vaccine Congress de Washington
Valneva SE will participate in the 26th World Vaccine Congress in Washington, D.C., from March 31 to April 2, 2026. The company's Vice President of Clinical Development will present Phase IV studies and real-world evidence for its chikungunya vaccine. Additionally, Valneva will engage with current and potential partners during the event.
Read more →VALNValneva to Participate in Multiple Events at the 26th World Vaccine Congress in Washington DC
Valneva SE will participate in the 26th World Vaccine Congress from March 31 to April 2, 2026, in Washington, D.C. The company's CEO and senior executives will present updates on their chikungunya vaccine and engage in discussions on vaccine development. Valneva is also launching a pilot vaccination campaign in Brazil for its chikungunya vaccine, IXCHIQ®, with over 12,000 people vaccinated.
Read more →VALNValneva gibt die konsolidierten geprüften Finanzergebnisse für das Gesamtjahr 2025 bekannt
Valneva SE reported consolidated financial results for the year ending December 31, 2025, showing a total revenue of €174.7 million, consistent with forecasts. The company highlighted a strong liquidity position of €109.7 million and a reduced operational cash burn. Looking ahead, 2026 is anticipated to be pivotal with Phase 3 data for its Lyme disease vaccine expected in the first half of the year.
Read more →VALNValneva publie ses résultats financiers audités et consolidés pour l’exercice 2025
Valneva SE reported its audited consolidated financial results for 2025, revealing a total revenue of €174.7 million, consistent with forecasts. The company holds a robust cash position of €109.7 million, following successful debt refinancing. Looking ahead, Valneva anticipates transformative developments in 2026, with Phase 3 data for its Lyme vaccine expected in the first half of the year.
Read more →VALNValneva Reports Full Year 2025 Audited Consolidated Financial Results
Valneva SE reported its audited financial results for 2025, showing total revenues of €174.7 million, slightly up from the previous year. The company highlighted a strong cash position of €109.7 million and a significant reduction in operating cash burn. Looking ahead, Valneva anticipates a transformative year in 2026 with Phase 3 data for its Lyme disease vaccine expected in the first half of the year.
Read more →VALNValneva to Report Full Year 2025 Consolidated Financial Results on March 18, 2026
Valneva SE announced that it will report its full year 2025 financial results on March 18, 2026. The company, known for its specialty vaccines, will also host a live webcast to discuss the financial outcomes and provide a business update. Valneva emphasizes its strong track record in advancing vaccine candidates and its ongoing commitment to addressing unmet medical needs through innovative vaccine solutions.
Read more →VALN▼ -6.1%on this news
Valneva to Participate in Upcoming March 2026 Investor Conferences
Valneva SE has announced its participation in several upcoming investor conferences in the U.S. and Europe. CEO Thomas Lingelbach and CFO Peter Buhler will present key value drivers, including the anticipated Phase 3 data readout for VLA15, their Lyme disease vaccine candidate. The conferences will provide opportunities for investor meetings and discussions about the company's growth and vaccine pipeline.
Read more →VALNValneva to Participate in Upcoming Investor Conferences
Valneva SE has announced its participation in several upcoming investor conferences where senior management will present the company's key value drivers, including the anticipated Phase 3 data readout for its Lyme disease vaccine candidate, VLA15. The conferences will take place in various locations across the United States and Europe, providing an opportunity for Valneva to engage with institutional investors. The company is noted for its focused approach in developing specialty vaccines, including partnerships that enhance its pipeline.
Read more →VALNValneva Reports Preliminary Unaudited 2025 Revenue and Cash and Provides 2026 Outlook
Valneva SE reported preliminary unaudited revenue results for 2025 and provided an outlook for 2026. The company anticipates significant developments in its Lyme disease vaccine candidate as it approaches Phase 3 data readout. Additionally, Valneva's Board has renewed CEO Thomas Lingelbach's mandate, emphasizing his critical role in the company's future growth.
Read more →VALNValneva Provides Update on Recommendations for Use of IXCHIQ in the United Kingdom
Valneva SE announced an update regarding its chikungunya vaccine, IXCHIQ, following a review by the UK Commission on Human Medicines. The updated recommendations include restrictions for individuals aged over 60 and those with specific health conditions. Despite these changes, the MHRA confirmed that the vaccine's benefit-risk ratio remains favorable for people aged 18 to 59 without contraindications. Valneva emphasizes its commitment to safety and ongoing monitoring of the vaccine's performance in collaboration with health authorities.
Read more →VALNValneva and Instituto Butantan Announce Initiation of a Pilot Vaccination Campaign in Brazil with Single-Shot Chikungunya Vaccine IXCHIQ®
Valneva SE and Instituto Butantan have launched a pilot vaccination campaign in Brazil using the single-shot chikungunya vaccine IXCHIQ®. This initiative aims to evaluate the vaccine's effectiveness and safety in a real-world setting, targeting adults aged 18 to 59. The program will cover ten municipalities and aims for 20% to 40% vaccine coverage. Valneva will donate up to 500,000 doses for this effort.
Read more →VALNValneva et l'Instituto Butantan annoncent le début d'une stratégie pilote de vaccination au Brésil avec le vaccin à injection unique IXCHIQ® contre le chikunguny
Valneva and Instituto Butantan have initiated a pilot vaccination campaign in Brazil using the single-dose chikungunya vaccine IXCHIQ®. This campaign aims to evaluate the vaccine's efficacy and safety in real-world conditions, targeting a vaccination coverage of 20% to 40% among adults aged 18 to 59. The program is part of a broader effort to address the chikungunya threat, especially in regions with high incidence rates.
Read more →VALNLeading Forward: Key Takeaways from 2025 and Priorities for 2026
In a recent reflection, Valneva's CEO Thomas Lingelbach highlighted the company's achievements in 2025, including a significant share price increase and successful debt refinancing. Looking ahead to 2026, the focus will be on the pivotal Phase 3 data for the Lyme disease vaccine candidate, VLA15, and maintaining strong partnerships. Lingelbach emphasized the importance of resilience and strategic readiness in navigating future challenges.
Read more →VALNValneva Provides Update on Chikungunya Vaccine IXCHIQ®
Valneva SE has announced the voluntary withdrawal of its biologics license application and Investigational New Drug application for its chikungunya vaccine IXCHIQ® following a suspension by the FDA. The FDA has also placed the IND on clinical hold due to a serious adverse event reported outside the U.S. Valneva is seeking further information regarding this event while continuing to engage with health authorities.
Read more →VALNValneva fait un point sur son vaccin contre le chikungunya IXCHIQ®
Valneva SE announced the voluntary withdrawal of its market authorization and clinical trial applications for its chikungunya vaccine IXCHIQ® following a suspension by the FDA. The FDA's decision was prompted by a serious adverse event reported outside the U.S. Valneva is seeking additional data to analyze this event while remaining committed to safety standards.
Read more →VALNValneva rencontrera des investisseurs lors de la J.P. Morgan Healthcare Conference
Valneva SE will meet with current shareholders and institutional investors at the J.P. Morgan Healthcare Conference from January 12-14, 2026. CEO Thomas Lingelbach and CFO Peter Bühler will discuss upcoming milestones, including pivotal Phase 3 results for their Lyme disease vaccine expected in the first half of the year. Valneva specializes in developing vaccines for infectious diseases.
Read more →VALNValneva to Meet with Investors during the J.P. Morgan Healthcare Conference
Valneva SE will meet with investors during the J.P. Morgan Healthcare Conference from January 12-14, 2026. CEO Thomas Lingelbach and CFO Peter Bühler will present updates on the company's clinical pipeline, including a pivotal data readout for its Lyme disease vaccine. The meetings aim to strengthen relationships with existing shareholders and attract new institutional investors.
Read more →VALNValneva SE - Declaration of voting rights - December 2025
Valneva SE has issued a declaration regarding its shares and voting rights as of December 31, 2025. The total number of ordinary shares is reported to be 173,539,745, with total voting rights recorded as 189,428,384. This includes new votes granted from stock options and other changes recognized between December 1 and December 27, 2025.
Read more →VALN▲ +5.6%on this news· ran to +17% by day 3
Valneva and Serum Institute of India Announce Discontinuation of Chikungunya Vaccine License Agreement
Valneva SE and Serum Institute of India have mutually agreed to end their license agreement for Valneva's chikungunya vaccine. This decision allows Valneva to regain full rights and control over its supply chain and commercialization efforts, particularly for endemic high-risk countries. Valneva aims to improve vaccine access in low-and-middle-income countries, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI). However, the termination of this agreement raises concerns about potential delays in bringing the vaccine to market and the competitive landscape in vaccine development.
Read more →VALNValneva Reports Positive Final Phase 2 Antibody Persistence and Safety Results in Children for its Chikungunya Vaccine IXCHIQ®
Valneva SE announced positive final results from its Phase 2 trial of the chikungunya vaccine IXCHIQ®, showing strong antibody persistence and safety in children. The trial, involving 304 participants, indicated a 94.7% seroresponse rate at 12 months post-vaccination. The company plans to initiate a Phase 3 trial after gathering more real-world data in adolescents, emphasizing the vaccine's importance in endemic regions.
Read more →VALNValneva annonce des résultats finaux de Phase 2 positifs sur la persistance des anticorps et l’innocuité de son vaccin contre le chikungunya IXCHIQ® chez les enfants
Valneva SE announced positive final results from its Phase 2 trial of the IXCHIQ® chikungunya vaccine in children. The study demonstrated robust antibody persistence and safety twelve months post-vaccination in 304 children. The findings support the initiation of a Phase 3 pediatric study, following additional real-world data collection in adolescents.
Read more →VALNValneva to Further Consolidate its Operations in France
Valneva SE is consolidating its operations in France by closing its Nantes site and relocating its registered office back to Lyon. This strategic initiative aims to enhance operational effectiveness and centralize R&D activities in Vienna. The company is committed to supporting employees throughout this transition, ensuring a smooth process.
Read more →VALNValneva va consolider ses activités en France
Valneva SE has announced a strategic initiative to consolidate its operations in France, focusing activities in Lyon while closing its Nantes site. This move aims to streamline operations and enhance efficiency, with all R&D activities being centralized in Vienna. The company is committed to supporting its employees through this transition.
Read more →VALN▲ +9.2%on this newsshared move
Valneva annonce des résultats finaux positifs de Phase 2 pour son candidat vaccin contre la maladie de Lyme
Valneva SE announced positive final results from the Phase 2 study of its Lyme disease vaccine candidate, VLA15. The study demonstrated a strong immune response and a favorable safety profile six months after a booster dose. With no existing human vaccine for Lyme disease, VLA15 is positioned as the most advanced candidate, with Phase 3 trials ongoing. Pfizer plans to submit market authorization applications in 2026, pending positive Phase 3 results.
Read more →VALN▲ +9.2%on this newsshared move
Valneva Announces Positive Final Phase 2 Results for Lyme Disease Vaccine Candidate
Valneva SE announced positive final results from its Phase 2 study of the Lyme disease vaccine candidate VLA15, demonstrating a strong immune response and a favorable safety profile. The study confirmed the effectiveness of a three-dose vaccination schedule and the necessity for yearly boosters. Pfizer plans to submit regulatory applications in 2026, pending positive Phase 3 results.
Read more →VALNValneva publie ses résultats financiers des neuf premiers mois de 2025 et fait un point sur ses activités
Valneva SE has released its financial results for the first nine months of 2025, showing a revenue increase to €119.4 million. The company is focusing on enhancing its financial flexibility and has confirmed its revised financial outlook. Valneva is also advancing its vaccine candidates, including the Lyme disease vaccine in Phase 3 trials and a promising Zika vaccine candidate with positive Phase 1 results.
Read more →VALNValneva Reports Nine-Month 2025 Financial Results and Provides Corporate Updates
Valneva SE reported its financial results for the first nine months of 2025, showing a sales increase to €119.4 million. The company successfully refinanced its debt and is preparing for a Phase 3 data readout for its Lyme disease vaccine candidate. However, Valneva also faced challenges, including a net loss and reduced third-party sales.
Read more →VALNValneva annonce des résultats positifs de Phase 1 pour son candidat vaccin de deuxième génération contre le virus Zika
Valneva SE announced positive Phase 1 results for VLA1601, its second-generation Zika vaccine. The trial demonstrated good safety and immunogenicity among 150 participants, with enhanced immune responses observed in groups receiving dual adjuvants. Despite these promising results, Valneva noted that further development hinges on securing funding and navigating regulatory uncertainties.
Read more →VALNValneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate
Valneva SE announced positive results from its Phase 1 trial of VLA1601, a second-generation Zika vaccine. The trial involved approximately 150 participants and showed that the vaccine was safe and well tolerated. Notably, the double-adjuvanted versions of the vaccine elicited significantly higher immune responses compared to previous candidates. However, the company faces uncertainties regarding regulatory pathways and funding for further development.
Read more →VALNValneva fera des présentations et rencontrera les investisseurs lors de conférences aux États-Unis et en Europe
Valneva SE announced that its management team will present and meet with institutional investors at upcoming conferences in the U.S. and Europe. Key topics will include the anticipated results from the Phase 3 trial of VLA15, a Lyme disease vaccine developed in partnership with Pfizer. If successful, Pfizer plans to submit market authorization applications in 2026.
Read more →VALNValneva to Present and Hold Investor Meetings at Upcoming U.S. and European Healthcare Conferences
Valneva SE announced its participation in several upcoming investor conferences in the U.S. and Europe, where management will discuss key value drivers and the Phase 3 trial outcomes for its Lyme disease vaccine candidate, VLA15. The company aims for Pfizer to submit market authorization applications in 2026, with a potential launch in 2027 if successful.
Read more →VALNValneva consolide sa position de trésorerie en refinançant sa dette auprès de Pharmakon Advisors et fait un point sur ses activités
Valneva SE has secured a new loan agreement with Pharmakon Advisors, allowing for up to $500 million in non-dilutive financing. The initial $215 million will fully repay existing debt, enhancing the company's financial flexibility. Despite a positive outlook for its Lyme disease vaccine candidate VLA15, Valneva has revised its financial forecasts for 2025 following the FDA's suspension of another vaccine's license.
Read more →VALNValneva Strengthens Financial Position by Refinancing Debt with Pharmakon Advisors and Provides Business Updates
Valneva SE has announced a new debt facility of up to $500 million with Pharmakon Advisors, which will enhance its financial flexibility and allow it to focus on its vaccine pipeline. The initial tranche of $215 million will repay existing debts, while the remaining funds may support future business development. The company also confirmed that its Lyme disease vaccine candidate, VLA15, remains on track for regulatory submissions in 2026, despite revising its financial outlook due to FDA-related uncertainties.
Read more →VALN▲ +11.4%on this news
Valneva Reports 95% Seroresponse Four Years After Single Shot of Chikungunya Vaccine IXCHIQ
Valneva SE announced that 95% of participants maintained neutralizing antibody levels four years after receiving a single dose of its chikungunya vaccine, IXCHIQ®. The long-lasting antibody response was consistent across both older adults (65+) and younger adults (18-64). The company emphasized the vaccine's competitive advantage for managing unpredictable outbreak diseases. No safety concerns were noted during the study, further supporting the vaccine's favorable profile.
Read more →VALNVALNEVA ALERT: Bragar Eagel & Squire, P.C. is Investigating Valneva SE on Behalf of Valneva Stockholders and Encourages Investors to Contact the Firm
Bragar Eagel & Squire, P.C. is investigating Valneva SE on behalf of its stockholders concerning potential violations of federal securities laws. Recent events, including the CDC's investigation into hospitalizations related to Valneva's chikungunya vaccine, IXCHIQ, have led to a notable drop in the stock price. Additionally, the FDA has suspended the marketing application for IXCHIQ due to safety issues. Investors who purchased Valneva shares and suffered losses are encouraged to contact the law firm for assistance.
Read more →VALNHarnessing Human Potential to Power Vaccine Innovation
In a recent Q&A, Petra Pesendorfer, Chief People Officer at Valneva, discussed the company's commitment to its mission of eradicating vaccine-preventable diseases. She emphasized the importance of a supportive culture that empowers employees across global sites. Valneva aims to nurture leadership and innovation while adapting to changes in the biotech market.
Read more →VALNValneva Reports Further Positive Phase 2 Safety and Immunogenicity Results for Lyme Disease Vaccine Candidate
Valneva SE reported positive results from its Phase 2 study of the Lyme disease vaccine candidate VLA15. The study showed a strong immune response after a third booster dose, consistent with prior findings. No safety concerns were noted by the independent Data Monitoring Committee across all age groups. The vaccine is progressing towards potential regulatory submission, addressing a significant unmet medical need, especially as Lyme disease cases continue to rise in endemic areas.
Read more →VALN▼ -19%on this news
Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine IXCHIQ in the U.S.
Valneva SE announced that the FDA has suspended the license for its chikungunya vaccine IXCHIQ® due to four new reports of serious adverse events. This suspension is effective immediately, halting all sales and shipments of the vaccine in the U.S. The decision followed updated data from the Vaccine Adverse Event Reporting System, revealing incidents mainly among elderly individuals. Valneva is investigating these cases and remains committed to working with health authorities and ensuring vaccine availability globally.
Read more →VALN▲ +5.3%on this news
Valneva’s Chikungunya Vaccine IXCHIQ Now Authorized in Canada for Individuals Aged 12 and Older
Valneva has received marketing authorization in Canada for its chikungunya vaccine, IXCHIQ®, making it available for individuals aged 12 and older. This extends the existing adult authorization and follows earlier adolescent label extensions in Europe. The vaccine demonstrated a strong safety profile and immunogenicity, evidenced by sustained antibody responses for 24 months. Health officials emphasize the importance of broad access as chikungunya continues to pose a health risk in endemic regions.
Read more →VALN▲ +10.6%on this news· ran to +36% by day 3
Valneva Reports Half Year 2025 Financial Results and Provides Corporate Updates
Valneva SE (Nasdaq: VALN) reported strong financial results for the first half of 2025, with total revenues increasing to €97.6 million, up 37.8% from the same period in 2024. Despite a net loss of €20.8 million, the company confirmed its positive financial outlook for the year ahead, predicting further growth in product sales. Valneva is focusing on maintaining cash management and reducing operating expenses while progressing with its clinical trials, including a pivotal Phase 3 study for a Lyme disease vaccine. Additionally, the firm announced several key regulatory updates and partnerships aimed at expanding its market reach.
Read more →VALNValneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ in Elderly and Updates to the Prescribing Information
Valneva SE has announced that the FDA has removed its recommended pause on the use of IXCHIQ, its chikungunya vaccine for individuals aged 60 and older, after a thorough safety review. The updates to the Prescribing Information now include warnings regarding serious adverse events, particularly among elderly patients with chronic conditions. While IXCHIQ remains authorized for adults at high risk of chikungunya exposure, healthcare professionals must carefully weigh the benefits and risks before administering the vaccine. Ongoing FDA reviews may lead to an expansion of the vaccine's indications.
Read more →VALNValneva Announces Lifting of European Medicines Agency’s Temporary Restriction on Use of Chikungunya Vaccine IXCHIQ in Elderly
Valneva SE has announced that the European Medicines Agency (EMA) will lift the temporary restriction on its chikungunya vaccine IXCHIQ for individuals aged 65 and above. This decision follows a comprehensive review by EMA's safety committee, which found that while serious side effects were observed mainly in the elderly with pre-existing conditions, the vaccine remains effective in generating protective antibodies. EMA emphasized that IXCHIQ should be administered in cases of significant chikungunya infection risk, balancing the benefits against potential risks.
Read more →VALNValneva Announces Exclusive Vaccine Marketing and Distribution Agreement for Germany with CSL Seqirus
Valneva SE has entered an exclusive marketing and distribution agreement with CSL Seqirus for its proprietary vaccines in Germany. The agreement will see CSL Seqirus commercializing Valneva's chikungunya vaccine IXCHIQ® starting July 2025, along with other vaccines from January 2026. This partnership aims to leverage CSL Seqirus's strong presence in Europe’s largest travel vaccine market and is expected to significantly boost Valneva's product sales. The agreement is set to last three years and includes minimum purchasing and standard termination clauses.
Read more →VALNStrengthening Preparedness against the Threat of Mosquito-Borne Diseases in the UK
Valneva has published a policy report focusing on the UK's preparedness against mosquito-borne diseases. The report outlines recommendations to strengthen surveillance, monitoring, and protection measures against diseases like dengue and Zika. It emphasizes the need for investment and collaboration with public health stakeholders to address emerging infectious disease threats effectively.
Read more →VALNValneva Announces Successful Outcome of its Annual General Meeting, Confirms FY 2025 guidance
Valneva SE successfully held its Annual General Meeting, where shareholders approved all board-recommended resolutions, including the 2024 financial statements and new board appointments. Dr. Gerd Zettlmeissl, an experienced vaccine expert, has been appointed to the Board for three years. The company also reaffirmed its financial guidance for the year 2025, indicating a stable outlook moving forward. Voting results from the AGM will be published soon on Valneva's corporate website.
Read more →VALNValneva Reports Positive Six-Month Antibody Persistence and Safety Phase 2 Results in Children for its Single-Shot Chikungunya Vaccine IXCHIQ
Valneva SE reported favorable results from its Phase 2 trial of IXCHIQ, a single-shot chikungunya vaccine for children aged one to eleven. The six-month data indicated a high and persistent antibody response, particularly at the full dose. Safety data also confirmed that the vaccine was well tolerated, leading to the decision to proceed with pivotal Phase 3 trials. Valneva anticipates commencing these trials in the first quarter of 2026 to expand the vaccine's availability for children.
Read more →VALN[Valneva SE] Declaration of shares and voting rights - May 2025
Valneva SE reported an update regarding its shares and voting rights as of June 5, 2025. The company confirmed a total of 170,188,190 ordinary shares and announced a capital increase resulting in the issuance of 2,916,666 new shares. The report includes details on total voting rights, both with and without the inclusion of suspended voting rights. This information is essential for shareholders and stakeholders to be aware of the latest changes in the company’s equity structure.
Read more →VALNValneva Announces Availability of Documentation for its Combined Shareholder Meeting and Provides Corporate Update
Valneva SE announced the availability of documentation for its Combined General Meeting scheduled for June 25, 2025. The meeting will include a preliminary agenda and proposed resolutions from the Board of Directors. Additionally, the company noted the departure of co-founder and Chief Business Officer Franck Grimaud. Valneva continues to develop its vaccine pipeline amidst business uncertainties, emphasizing its commercial vaccine offerings and ongoing partnerships.
Read more →VALNValneva Provides Update on Recommended Use of IXCHIQ by Elderly Individuals in the United States
Valneva SE announced that the FDA and CDC have recommended a pause in the use of its chikungunya vaccine IXCHIQ® for elderly individuals due to reported serious adverse events currently under investigation. This decision follows previous guidance from health authorities, including the EMA's suspension for individuals over 65 years. Despite this, the vaccine is still recommended for younger individuals aged 18 to 60, as safety evaluations continue. Valneva is actively collaborating with regulatory agencies to address safety concerns raised from vaccination efforts, particularly in La Réunion.
Read more →VALNValneva Reports First Quarter 2025 Financial Results and Provides Corporate Updates
Valneva SE reported its first quarter 2025 financial results, showcasing a 50.3% increase in total revenues to €49.2 million compared to the same quarter in 2024. The company confirmed its financial outlook for the year, indicating anticipated product sales growth to €170-180 million. However, a net loss of €9.2 million was reported, significantly lower than the prior year's profit, impacted by the sale of a Priority Review Voucher in 2024. Additionally, recent recommendations from health authorities regarding IXCHIQ® vaccine use in older adults raised safety concerns following adverse events.
Read more →VALNValneva Provides Update Following European Medicines Agency Announcement on Use of IXCHIQ in Elderly
Valneva provided an update on its chikungunya vaccine IXCHIQ following the European Medicines Agency's (EMA) review initiated due to serious adverse events reported in elderly individuals. The EMA has temporarily suspended the vaccine's use in people over 65 years old, while maintaining its availability for those aged 12 to 64. The decision arose from 17 reported serious adverse events globally, including two fatalities, linked to individuals with pre-existing health conditions. Valneva is closely monitoring the situation and is committed to ensuring product safety as investigations proceed.
Read more →VALN▼ -6.5%on this news
Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities
Valneva SE announced an update on its chikungunya vaccine IXCHIQ following a recommendation by France's Haute Autorité de Santé (HAS). The recommendation for use in individuals aged 65 and older has been suspended due to serious adverse events reported during the vaccination campaign in La Reunion and Mayotte, including one death. IXCHIQ remains authorized for adults aged 18 to 64, with ongoing investigations into the reported adverse events. Valneva continues to support vaccination efforts amid the significant chikungunya outbreak in La Reunion.
Read more →VALNValneva SE Company Investigated by the Portnoy Law Firm
Valneva SE is currently facing an investigation by the Portnoy Law Firm related to potential securities fraud, as the firm considers filing a class action lawsuit on behalf of affected investors. This follows a notice from the CDC regarding serious health events linked to Valneva's chikungunya vaccine, IXCHIQ, which has negatively impacted the company's stock price. Valneva's ADRs saw a significant decline of approximately 13.57% after the CDC's announcement, raising concerns among investors.
Read more →VALNValneva Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ Among U.S. Travelers
Valneva SE announced an update regarding its chikungunya vaccine IXCHIQ after the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) maintained its existing recommendation for the vaccine for individuals aged 18 and older traveling to chikungunya outbreak areas. Additionally, a precaution was issued for vaccination in those aged 65 and over due to six reported serious adverse events. Despite the precaution, Valneva continues to supply doses and has not identified new safety concerns. The recommendation awaits final approval from CDC leadership.
Read more →VALN▼ -6.9%on this newsshared move
Valneva to Participate in Multiple Events at the 25th World Vaccine Congress, including a Presentation on its Chikungunya Vaccine IXCHIQ
Valneva SE announced its participation in the 25th World Vaccine Congress, scheduled for April 21-24, 2025, in Washington, D.C. The company will present its chikungunya vaccine IXCHIQ® and engage in discussions about prophylactic enteric disease vaccines. Valneva is also a finalist for the Best Biotech Award and Best Prophylactic Vaccine Award at the Vaccine Industry Excellence Awards for its Lyme disease vaccine candidate VLA15. The congress will be a platform for Valneva to share advancements in its vaccine pipeline and to discuss the urgent need for vaccines against mosquito-borne diseases.
Read more →VALN▲ +12.1%on this newsshared move
Valneva Receives First Marketing Authorization for IXCHIQ in a Chikungunya Endemic Country
Valneva SE's IXCHIQ® vaccine has received marketing authorization from Brazil's ANVISA, marking the first approval of a chikungunya vaccine in an endemic country. This approval is part of Valneva's strategy to expand vaccine access in lower-middle-income countries, facilitated by partnerships with CEPI and Instituto Butantan. The decision allows for large-scale clinical trials to generate more data on the vaccine's effectiveness. Moreover, Valneva expects further approvals for its vaccine candidates, supporting increased access in regions severely affected by chikungunya.
Read more →VALN▲ +12.1%on this newsshared move
Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2
Valneva SE and LimmaTech Biologics AG have commenced a Phase 2 study to evaluate the safety and immunogenicity of their tetravalent Shigella vaccine candidate, S4V2, in infants. The trial involves approximately 110 nine-month-old participants and aims to determine the optimal vaccine dose for further studies. Supported by the Gates Foundation, this initiative addresses a critical health issue, as shigellosis significantly impacts child mortality rates worldwide. The results of the study are anticipated in the latter half of 2025, following a thorough safety evaluation.
Read more →VALNValneva SE Shareholding Declaration - March 2025
Valneva SE announced a shareholding declaration on April 3, 2025, detailing the company's current share capital and voting rights. As of the declaration, Valneva has 162,521,524 ordinary shares and 178,409,478 voting rights, including those for shares with suspended voting rights. The report indicates that double voting rights have been granted on 1,456 ordinary shares. This declaration reflects changes recognized between March 2 and March 28, 2025.
Read more →VALNValneva’s Chikungunya Vaccine IXCHIQ Now Authorized in EU for Adolescents Aged 12 and Above
Valneva SE announced that the European Commission has granted marketing authorization for its chikungunya vaccine, IXCHIQ, for adolescents aged 12 and above in the EU. This authorization expands access beyond adults, addressing a critical public health concern as chikungunya outbreaks increase in several regions, including India and Brazil. The decision is based on positive Phase 3 data showcasing a strong immune response from a single dose. Valneva aims to increase vaccine accessibility globally, including partnerships to ensure affordability in low- and middle-income countries.
Read more →VALN▼ -7.6%on this newsshared move
Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ , to UK MHRA
Valneva SE has announced the submission of a label extension application to the UK Medicines and Healthcare products Regulatory Agency for its chikungunya vaccine, IXCHIQ, to include adolescents aged 12 to 17. The vaccine, currently approved for adults, has demonstrated strong efficacy with positive Phase 3 data showing high immune response rates in adolescents. This initiative responds to the urgent public health issue posed by chikungunya, which has seen outbreaks in several regions. Valneva has also been expanding its partnerships to improve access to this vaccine globally, particularly in low- and middle-income countries.
Read more →VALNValneva Renews its Sales Agreement in connection with its Existing At-the-Market (ATM) Program
Valneva SE has renewed its existing At-the-Market (ATM) program, allowing for the potential sale of up to $75 million of American Depositary Shares. The renewal follows the filing of a prospectus supplement with the SEC, and the timing of any future sales remains uncertain as the company is not obligated to engage in such sales. Funds generated from the ATM program are intended to support various corporate needs including R&D and commercialization efforts. As of now, the ATM program has not been utilized since its inception in August 2022.
Read more →VALNValneva Announces Filing of 2024 Universal Registration Document and US Form 20-F
Valneva SE has filed its 2024 Universal Registration Document with the French Financial Markets Authority and its Form 20-F with the U.S. Securities and Exchange Commission. This documentation includes important reports such as the Annual Financial Report and the Corporate Governance Report. The company continues to focus on advancing its specialty vaccines for infectious diseases and highlights its commitment to addressing unmet medical needs through its vaccine development efforts.
Read more →VALN▲ +7.7%on this newsshared move
Valneva Reports Full Year 2024 Results and Provides Business Updates and Outlook
Valneva SE reported its consolidated financial results for 2024, highlighting a 13% increase in product sales and a net loss reduction from €101.4 million in 2023 to €12.2 million in 2024. The company emphasized a strong year-end cash position of €168.3 million and a 67% decrease in operating cash burn. Notably, Valneva anticipates continuous growth for 2025, projecting product sales to reach between €170 million and €180 million, accompanied by significant R&D investments. The outlook is bolstered by regulatory advancements for its chikungunya vaccine and ongoing clinical programs, particularly in Lyme disease.
Read more →VALNCelebrating Women in the Workplace: Progress, Challenges, and Advice to Future Female Leaders
The article reflects on the progress and challenges faced by women in leadership roles, particularly in the biopharma industry. The author, Kendra Wergin, shares her experiences at Valneva and emphasizes the importance of female representation in leadership. She offers advice for future female leaders, encouraging them to embrace their strengths and challenge self-doubt.
Read more →VALNValneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences
Valneva SE announced that its senior management will present at two significant investor conferences: the TD Cowen Annual Health Care Conference in Boston and the Van Lanschot Kempen Life Sciences Conference in Amsterdam. During these events, they will discuss their promising pipeline of vaccines, including VLA15 for Lyme disease, along with other programs targeting infectious diseases. With expectations of generating substantial revenues from their marketed vaccines in 2025, the company aims to highlight their advancements in vaccine development to prospective investors.
Read more →VALN▼ -5.2%on this newsshared move
Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ
Valneva SE has received a positive opinion from the EMA's CHMP for a label extension of IXCHIQ, its chikungunya vaccine, allowing use in adolescents aged 12 and older. The decision follows promising Phase 3 trial data showing a 99.1% immune response in this demographic. The European Commission will review the recommendation, with an expected decision in 60 days. Valneva is also pursuing similar approvals in other regions to enhance vaccine accessibility against chikungunya, a growing public health concern.
Read more →VALN▲ +9.9%on this news
Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook
Valneva SE has announced its preliminary unaudited revenue figures for 2024, indicating a 10% increase in total revenue to €169.6 million, driven by a 13% rise in product sales. The company reported a robust cash position of €168.3 million and outlined optimistic projections for 2025, expecting further revenue growth and ongoing strategic investments in research and development. Despite some challenges, including underwhelming launch sales for its IXCHIQ® vaccine, Valneva is well-positioned to capitalize on upcoming clinical data and regulatory approvals in the near future.
Read more →VALN▲ +18.9%on this news
Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ
Valneva SE has received marketing authorization in the UK for IXCHIQ, the first chikungunya vaccine. This approval follows positive Phase 3 clinical trial data demonstrating a robust immune response in over 4,000 participants. The vaccine, which is already approved in the US, Europe, and Canada, is expected to aid in protecting travelers and combatting outbreaks, particularly in India. Valneva is also seeking to expand vaccine access to adolescents and endemic regions through partnerships.
Read more →VALNValneva Announces New IXIARO Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million
Valneva SE has announced a new contract worth at least $32.8 million with the U.S. Department of Defense for the supply of its Japanese encephalitis vaccine, IXIARO. This one-year agreement allows for additional purchases during the contract period, reinforcing the military's reliance on IXIARO to protect personnel from Japanese encephalitis. The vaccine is the only one approved for use in the U.S. and has been a trusted option for over a decade. The contract begins immediately, following successful deliveries under a previous agreement.
Read more →VALNGlobal Health Challenges: Prioritizing Equitable and Affordable Access in LMICs
Valneva emphasizes the importance of equitable and affordable healthcare access in low- and middle-income countries (LMICs). The company is committed to developing vaccine solutions and forming strategic partnerships to enhance access for vulnerable populations. However, challenges such as regulatory delays and inadequate healthcare financing persist, hindering progress towards global health equity.
Read more →VALNValneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision
Valneva SE has announced positive results from its Phase 2 clinical trial of the chikungunya vaccine, IXCHIQ®, in children aged one to eleven. The trial demonstrated good safety and immunogenicity, supporting the decision to advance to a Phase 3 study scheduled for late 2025. The vaccine, which is already approved for adults, aims to extend its use to younger populations in light of the ongoing chikungunya virus outbreaks. This effort is crucial for improving vaccine access, particularly in low- and middle-income countries.
Read more →VALN▲ +7.8%on this newsshared move
Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine
Valneva SE reported promising Phase 3 results for its chikungunya vaccine, showing a sustained 98.3% sero-response rate in adolescents one year post-vaccination. The data supports regulatory applications for extending usage to ages 12-17 in the U.S., Europe, and Canada, while also potentially aiding in licensure in Brazil. The trial indicates that the vaccine is generally well tolerated, with an Independent Data Safety Monitoring Board finding no safety issues. These results bolster Valneva's partnership efforts to improve vaccine access in low- and middle-income countries.
Read more →VALN▲ +17.2%on this news
Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India
Valneva SE has announced an exclusive license agreement with the Serum Institute of India (SII) for the manufacture and distribution of its chikungunya vaccine in Asia. This collaboration aims to address a significant chikungunya outbreak in India, where nearly 370,000 cases have been confirmed. Under the agreement, Valneva will provide the drug substance to SII, which will oversee regulatory approvals and supply of the vaccine. The partnership is supported by a $41.3 million funding agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and aims to ensure affordable access to the vaccine for low-and-middle-income countries.
Read more →VALNValneva Announces Peer-Reviewed Publication on the Global Health and Economic Burden of Chikungunya in The British Medical Journal
Valneva SE has announced the publication of a significant article in The British Medical Journal, detailing the global health and economic burden of chikungunya. The analysis reveals that the disease has a higher prevalence than previously estimated, with considerable economic impacts amounting to nearly $50 billion over a decade. The findings underscore the urgent need for effective prevention strategies, particularly as climate change exacerbates the spread of mosquito-borne diseases. This publication is expected to inform public health policy and bolster Valneva's position in vaccine development.
Read more →VALNValneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ
Valneva SE announced encouraging three-year antibody persistence results for its chikungunya vaccine IXCHIQ®, demonstrating that 96% of participants maintained strong neutralizing antibody levels. These findings confirm the vaccine's effectiveness in providing lasting protection across diverse age groups. IXCHIQ® is notably the first llama licensed chikungunya vaccine available, with extensive applications for travelers and residents in endemic regions. With plans for expanded marketing in low- and middle-income countries and recent submissions for label extensions for adolescents, Valneva aims to enhance vaccine accessibility.
Read more →VALN▼ -6.9%on this news
Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ , to the U.S. FDA
Valneva SE has submitted a label extension application to the U.S. FDA for its chikungunya vaccine IXCHIQ, aiming to include adolescents aged 12 to 17 years. This application is based on favorable Phase 3 clinical data indicating that IXCHIQ induces a high immune response in 99.1% of adolescents, along with data on long-term antibody persistence. The vaccine is already approved for adults and represents the first licensed chikungunya vaccine. Valneva is also expanding its access initiatives in light of growing chikungunya cases worldwide.
Read more →VALNValneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2
Valneva SE and LimmaTech Biologics have initiated a Phase 2b human challenge study for the tetravalent Shigella vaccine candidate S4V2, having vaccinated the first participant. This study involves approximately 120 healthy volunteers and aims to assess the vaccine's safety and preliminary efficacy against Shigella sonnei strain 53G. With Fast Track designation from the FDA, the study is crucial in moving toward bringing this much-needed vaccine to market, targeting the global health threat caused by shigellosis, which currently lacks an approved vaccine.
Read more →VALNValneva Reports Nine-Month 2024 Financial Results and Provides Corporate Updates
Valneva SE reported positive financial results for the first nine months of 2024, achieving total revenues of €116.6 million and a net profit of €24.7 million. The company highlighted the launch of the world’s first chikungunya vaccine and secured an exclusive worldwide license for a Shigella vaccine candidate. Valneva also narrowed its full-year 2024 financial guidance, indicating expected product sales between €160 million and €170 million. However, third-party vaccine sales saw a reduction due to supply issues, and initial pragmatism on chikungunya vaccine sales was noted.
Read more →VALNMore mosquitoes and mosquito-borne diseases are the ‘new normal’
The article discusses the alarming rise in mosquito populations and mosquito-borne diseases, particularly Chikungunya, which has seen a four-fold increase in India. It highlights the connection between climate change and the proliferation of mosquitoes, urging travelers to take preventive measures. Awareness and preparation are emphasized as essential for reducing risks associated with these diseases.
Read more →VALNValneva to Present on Chikungunya at Several Leading Scientific Conferences
Valneva SE announced that its leadership will present data on IXCHIQ®, the first and only approved chikungunya vaccine, at various prestigious scientific conferences in Q4 2024. Key presentations will focus on safety and antibody persistence data and the cost-effectiveness of vaccination. Events include the International Society of Vaccines Annual Congress and the American Society of Tropical Medicine and Hygiene Annual Meeting. This outreach highlights Valneva's commitment to addressing global health needs with innovative vaccine solutions.
Read more →VALNValneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V
Valneva SE and LimmaTech Biologics AG announced that the FDA has granted Fast Track designation to their Shigella4V (S4V) vaccine candidate. This designation aims to expedite the clinical development and review process for treatments addressing serious medical conditions. Shigellosis, caused by the Shigella bacteria, presents a major global health threat with substantial morbidity and mortality rates, particularly in low- and middle-income countries. With no approved vaccine currently available, this designation establishes a pathway for S4V's further clinical trials, expected to begin before the end of 2024.
Read more →VALNValneva Hosts Investor Day in New York City
Valneva SE is hosting an investor day today in New York City, focusing on its future opportunities over the next 12-18 months. The event will showcase key developments in its vaccine portfolio, notably the fully enrolled Phase 3 trial of its Lyme disease vaccine candidate VLA15, which is in collaboration with Pfizer. Additionally, Valneva's commercial vaccine offerings, including IXCHIQ® for chikungunya, will be highlighted alongside ongoing clinical studies in its R&D pipeline. The CEO anticipates achieving profitability by 2027 if VLA15 receives regulatory approval and launches successfully.
Read more →VALNValneva SE - Declaration of shares and voting rights - September 30, 2024
Valneva SE has issued a declaration of shares and voting rights as of September 30, 2024. The company reported a total of 162,276,901 ordinary shares and a capital increase through the issuance of 23,000,000 new shares. Additionally, 750,000 shares have been transferred to bearer form, and double voting rights were granted on 363 ordinary shares. These changes are recognized as of mid-September 2024.
Read more →VALNValneva to Host Investor Day in New York on Thursday, October 10, 2024 at 10:00 AM ET
Valneva SE announced the hosting of an investor day on October 10, 2024, at the Lotte New York Palace Hotel. The event will cover the company's advanced R&D pipeline, including vaccine candidates for Lyme disease, Shigella, and Zika. Key speakers will include CEO Thomas Lingelbach and other management members, with a Q&A session to follow. The event aims to highlight Valneva's current portfolio and future potential in the vaccine market.
Read more →VALNValneva Canada wins International Rx Award
Valneva Canada has been awarded the International Rx Award for its marketing campaign 'Gear Up Before You Go!' for Dukoral®. This recognition showcases the company's commitment to excellence in healthcare marketing. The award celebrates the creativity and effort of the Valneva team in promoting public health.
Read more →VALNValneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ , to EMA and Health Canada
Valneva SE has submitted label extension applications for its chikungunya vaccine, IXCHIQ®, to the European Medicines Agency and Health Canada, aiming to include adolescents aged 12 to 17. The applications are based on promising Phase 3 data showing a high immune response and two-year antibody persistence. Valneva also anticipates submitting data to the U.S. FDA for potential U.S. label extensions later this year. The company has partnered with CEPI to further broaden access to the vaccine in developing regions, securing additional funding for these efforts.
Read more →VALNValneva Scotland Wins RoSPA Silver Award
Valneva Scotland has been awarded the RoSPA Silver Award for its outstanding health and safety performance in 2023. The award was accepted by Paulina Meducka and Kathleen Haddow at a ceremony in London. This recognition underscores Valneva's commitment to maintaining high safety standards and ensuring a safe working environment for its employees.
Read more →VALN▼ -8.5%on this newsshared move
Valneva Announces the Success of its Private Placement Raising approximately €60 Million
Valneva SE has successfully raised approximately €61.18 million through a private placement aimed at funding various clinical programs, including the chikungunya vaccine and a new Shigella vaccine. The company will use the proceeds to strengthen its commercial and R&D activities, enhancing its operational flexibility. Despite this positive development, Valneva has significant debt obligations and faces potential market volatility and share dilution risks. The adjustments to shareholder stakes post-offering indicate a notable change in capital distribution.
Read more →VALNValneva Announces the Launch of a Private Placement of Ordinary Shares for Approximately 60 Million Euros
Valneva SE has announced a private placement of approximately 22.6 million new ordinary shares at €2.66 per share, aiming to raise around 60 million Euros. The funds will primarily support the development of its vaccine programs, including those for chikungunya, Shigella, and Zika. The placement period is expected to close shortly after the announcement, with the shares set to begin trading on Euronext Paris. The initiative comes as Valneva anticipates financing its operations until potential milestone revenues begin from its Lyme disease vaccine program.
Read more →VALNValneva Austria at the Business Run 2024
Valneva Austria participated in the Vienna Business Run 2024, with 41 employees joining 33,000 other runners in a 4.3 km race on Danube Island. The event showcased remarkable team spirit and ambition among the participants. Valneva expressed gratitude to the organizers for the smooth execution of the event.
Read more →VALNValneva and Pfizer Report Further Positive Phase 2 Booster Results for Lyme Disease Vaccine Candidate
Valneva SE and Pfizer Inc. have reported positive results from their Phase 2 study of the Lyme disease vaccine candidate VLA15, following a second booster dose. The study demonstrated a robust immune response and a favorable safety profile across pediatric and adult populations. Significantly, the vaccine candidate is the most advanced in clinical development for Lyme disease, with ongoing Phase 3 trials aimed at further establishing its efficacy and safety. With approximately 476,000 Lyme disease cases treated annually in the U.S., the development of this vaccine addresses a substantial unmet medical need.
Read more →VALNWorld Mosquito Day: How Getting Malaria as a Child Shaped My Life and Gave Purpose to My Career
Greig Rooney, Managing Director of Valneva, reflects on how contracting malaria as a child in Yemen shaped his career in life sciences. He emphasizes the ongoing global threat of mosquito-borne diseases and the need for improved healthcare access. Rooney expresses pride in Valneva's mission to prevent vaccine-preventable diseases.
Read more →VALN▲ +7.3%on this news
Valneva Reports Half Year 2024 Financial Results and Provides Corporate Updates
Valneva SE reported its financial results for the first half of 2024, confirming revenue guidance between €170 million and €190 million for the full year. The company posted total revenues of €70.8 million and a net profit of €34 million, marking a substantial turnaround from a loss in the same period last year. Valneva continues to expand its vaccine pipeline with recent approvals for its chikungunya vaccine IXCHIQ and advancements in its Lyme disease vaccine candidate. However, product sales saw a slight decline due to supply constraints and lower third-party sales.
Read more →VALNValneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate
Valneva SE has entered a strategic partnership with LimmaTech Biologics AG to develop the S4V tetravalent vaccine candidate against shigellosis, a serious global health issue. Valneva has acquired an exclusive worldwide license for the vaccine, which is expected to enter Phase 2 clinical trials soon. The collaboration involves upfront payments and potential future royalties for LimmaTech, while Valneva assumes responsibility for further development and commercialization. The partnership aims to address a significant unmet medical need for a vaccine against Shigella bacteria, which causes severe diarrhea and mortality worldwide.
Read more →VALNValneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate
Valneva SE has entered a strategic partnership with LimmaTech Biologics to develop the Shigella4V (S4V) vaccine, aimed at addressing shigellosis, a leading cause of diarrheal disease. Under the agreement, LimmaTech will receive an upfront payment and royalties, while conducting pivotal Phase 2 trials starting mid-2024. Valneva's CEO expressed optimism about the partnership's potential to meet significant health needs in both low-income and high-income regions. This move will enhance Valneva's vaccine development pipeline at a time when no licensed Shigella vaccine exists.
Read more →VALNMosquito Borne Disease at the Paris Olympics: Reducing the Risk
As the Paris Olympics approach, organizers are intensifying efforts to mitigate health risks, particularly from mosquito-borne diseases like dengue and zika. With the presence of disease-carrying mosquitoes in France and the potential influx of attendees from endemic regions, health authorities are enhancing surveillance and public education. Innovative prevention strategies, including mosquito traps and vaccination awareness, are being emphasized to protect public health during the event.
Read more →VALNValneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ
Valneva SE has received marketing authorization from the European Commission for IXCHIQ®, the first licensed chikungunya vaccine for those 18 and older. This approval follows endorsements from EU member states and the European Medicines Agency, highlighting the vaccine's efficacy demonstrated in clinical trials. Valneva is preparing to deliver initial doses in Europe by the fourth quarter of 2024. Additionally, efforts are underway for approvals in the UK and Brazil, expanding accessibility in low- and middle-income countries. This development is significant amid rising chikungunya cases linked to climate change.
Read more →VALNValneva Announces Successful Outcome of its Combined General Meeting and Appointment of a New Director to its Board
Valneva SE held its Combined General Meeting in Lyon, France, where shareholders approved all proposed resolutions. This included the appointment of Danièle Guyot-Caparros to the Board of Directors for a three-year term, who has extensive experience in finance and the pharmaceutical industry. The meeting also included approvals related to financial statements and share capital management. Valneva continues to focus on developing vaccines for infectious diseases, leveraging its strong commercialization track record.
Read more →VALN▲ +8.9%on this newsshared move
Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ
Valneva SE has received Health Canada approval for IXCHIQ, the first licensed chikungunya vaccine, which is shown to be highly effective with a 98.9% seroresponse rate after one dose. This approval follows a prior FDA approval and aims to address significant public health needs as chikungunya cases rise globally, exacerbated by climate change. The vaccine will be commercialized in Canada in late 2024, following a similar rollout in the U.S. Valneva is also working with CEPI to enhance accessibility in low- and middle-income countries.
Read more →VALNValneva to Present and Hold Investor Meetings at Upcoming Conferences in June
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) announced its participation in multiple investor conferences in June 2024, where it will present key updates regarding its vaccine development programs. The company will discuss its Lyme Disease vaccine candidate VLA15, which is in Phase 3, along with the commercial launch of IXCHIQ®, the first chikungunya vaccine, and VLA1601, its Zika virus vaccine in early clinical development. These presentations aim to engage with global institutional investors and discuss Valneva's growth and prospects in the vaccine industry.
Read more →VALNValneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases
Valneva SE announced that the results of two Phase 2 clinical trials for their Lyme disease vaccine candidate, VLA15, were published in The Lancet Infectious Diseases. The trials support the current pivotal Phase 3 trial aimed at determining the vaccine's efficacy and safety for people aged five and older in endemic regions. VLA15 demonstrated immunogenicity across multiple dose levels and has a favorable safety profile, with support from an independent Data Safety Monitoring Board. The company, in collaboration with Pfizer, intends to submit regulatory applications upon positive outcomes from ongoing trials.
Read more →VALNValneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine
Valneva SE has received a positive opinion from the EMA's CHMP for its single-dose chikungunya vaccine, IXCHIQ®, marking a significant step toward EU market authorization. If approved, it will be the first chikungunya vaccine available in the EU, addressing an urgent medical need as outbreaks become more common due to climate change. The European Commission's decision on marketing authorization is anticipated in Q3 2024, following the prior approval of IXCHIQ® by the FDA. This move is crucial for protecting both travelers to endemic regions and local populations against the chikungunya virus.
Read more →VALNValneva Sweden at the opening ceremony for International Vaccine Institute’s new European office in Stockholm
Valneva Sweden participated in the opening ceremony of the International Vaccine Institute's new European office in Stockholm on May 3, 2024. The event emphasized the importance of public-private partnerships in vaccine research and development. Key figures from IVI and academia discussed strategies for enhancing global health through innovative vaccine solutions.
Read more →VALN▼ -7.2%on this news
Valneva Appoints Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer
Valneva SE has appointed Dr. Hanneke Schuitemaker as Chief Scientific Officer, effective June 3, 2024. Dr. Schuitemaker brings over 20 years of experience in vaccine development, having previously worked at Johnson & Johnson and other notable institutions. Her role will enhance Valneva's R&D portfolio, particularly in developing innovative vaccine solutions. Thomas Lingelbach, CEO of Valneva, expressed confidence in her ability to contribute to the company's strategic ambitions in the vaccine sector.
Read more →VALNValneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine
Valneva SE has reported positive results from its pivotal Phase 3 trial of a single-shot chikungunya vaccine, VLA1553, in adolescents aged 12 to 17. The latest data confirms strong immunogenicity and safety, with a high seroresponse rate of 99.1% at six months post-vaccination. These results are intended to support a filing for a label extension for adolescent use and seek licensure in Brazil. Valneva's vaccine is the first licensed for chikungunya, addressing a significant public health need as the virus continues to pose risks globally.
Read more →VALNValneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates
Valneva SE reported its first-quarter financial results for 2024, revealing total revenues of €32.8 million, including a net profit of €58.9 million. Key highlights include stable cash reserves of €176.6 million and an improved cash burn rate anticipated for the year. The company reaffirmed its financial guidance, expecting total revenues between €170 million and €190 million. Regulatory advancements for its chikungunya vaccine IXCHIQ® were noted, alongside ongoing Phase 3 trials for its Lyme disease vaccine candidate.
Read more →VALNValneva France Highlights Travel Medicine at the SMV Congress
Valneva France participated in the SMV Congress in Paris, focusing on travel medicine. The event attracted 130 participants from travel health clinics, featuring two stands for medical inquiries and product information. Presentations included discussions on chikungunya vaccines and health risks related to the upcoming Paris 2024 Olympic Games.
Read more →VALNEarth Day 2024: Our Commitment to Sustainability
Valneva emphasizes its commitment to sustainability, particularly in the context of climate change and public health. The company has implemented various initiatives to reduce its environmental impact, including a significant reduction in CO2 emissions and the launch of a Zero Waste to Landfill project. Valneva aims to integrate sustainability into its corporate governance and operations, linking it to performance-based remuneration.
Read more →VALNValneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate
Valneva SE has announced the initiation of a Phase 1 clinical trial for VLA1601, its second-generation Zika vaccine candidate aimed at improving safety and immunogenicity against the Zika virus. The trial will involve approximately 150 participants and is set to assess various dose levels, with topline data expected by mid-2025. This initiative is significant as no preventive vaccines or effective treatments currently exist for Zika virus, emphasizing the ongoing public health threat posed by this disease.
Read more →VALNValneva Announces Filing of 2023 Universal Registration Document and US Form 20-F
Valneva SE has filed its 2023 Universal Registration Document with the French Financial Markets Authority and Form 20-F with the U.S. Securities and Exchange Commission. The filings include critical reports, such as the Annual Financial Report and Sustainability Report, available on their corporate website. Valneva continues to focus on developing vaccines for infectious diseases and has advanced multiple candidates through clinical development, including a Lyme disease vaccine in partnership with Pfizer. The company emphasizes its specialization in fulfilling unmet medical needs in global health.
Read more →VALNValneva to Present on its Chikungunya Vaccine IXCHIQ , Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C.
Valneva SE has announced its participation in the 24th World Vaccine Congress set for April 1-4, 2024, in Washington, D.C. The company will present its chikungunya vaccine IXCHIQ and moderate discussions on related public health threats. Valneva is also a finalist for the Vaccine Industry Excellence Award for IXCHIQ, marking a significant recognition of their contributions to vaccine development. Notably, IXCHIQ is the first vaccine specifically for chikungunya, approved in the U.S. with recommendations from health authorities.
Read more →VALN▼ -10.4%on this newsshared move
Valneva Reports Full Year 2023 Results and Provides Business Updates and Outlook
Valneva SE reported its 2023 financial results, revealing total revenues of €153.7 million and significant product sales growth, driven by the newly approved chikungunya vaccine IXCHIQ®. The company expects improved product sales between €160 million and €180 million for 2024, despite projected declines in third-party sales due to anticipated supply constraints. Strategic financial maneuvers and cost management efforts have positioned Valneva for a sustainable operational run until revenues from the Lyme program materialize, which is crucial for long-term profitability.
Read more →VALNValneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed
Valneva SE has announced an extension of the interest-only period for its debt facility with Deerfield Management Company and OrbiMed by 18 months. As a result, reimbursements for the first $100 million tranche will now begin in January 2026 instead of July 2024, while maintaining a maturity date in the first quarter of 2027. This financial maneuver is expected to bolster Valneva's cash position and support its potential profitability, particularly linked to the commercial launch of its Lyme disease vaccine program.
Read more →VALNValneva Austria recognized once again as a family-friendly employer with the “Familie und Beruf” certificate
Valneva Austria has been awarded the 'Familie und Beruf' certificate for its commitment to being a family-friendly employer. This recognition highlights the company's efforts in supporting employees' work-life balance, particularly through flexible hybrid work policies. Valneva is dedicated to implementing additional family-friendly measures in the future.
Read more →VALNValneva Hosted at the Residence of the French Ambassador to the United States
In February 2024, Valneva was hosted by French Ambassador Laurent Bili at the Residence de France in Washington, DC. The event focused on public-private partnerships addressing neglected tropical diseases, particularly chikungunya virus. Valneva's executives spoke on the importance of innovation and equitable access in global health strategies.
Read more →VALNValneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance
Valneva SE reported total revenues of €153.7 million for the full year 2023, a decrease compared to €361.3 million in 2022, primarily due to lower COVID-19 vaccine sales. The company achieved a strong product sales performance, with a 63% increase when excluding COVID-19 vaccines. For 2024, Valneva anticipates product sales between €150 million and €180 million while navigating potential supply constraints. The cash position as of December 31, 2023, stood at €126.1 million, excluding recent proceeds from a Priority Review Voucher sale.
Read more →VALNValneva Announces Sale of Priority Review Voucher for $103 Million
Valneva SE has announced the sale of a Priority Review Voucher (PRV) from the FDA for $103 million, which will boost its research and development activities. The PRV was awarded following the approval of IXCHIQ®, Valneva's chikungunya vaccine, the first of its kind. The proceeds from the sale will be invested in ongoing clinical trials and further development of vaccine candidates, including those for Lyme disease. This funding represents a substantial non-dilutive capital source for Valneva as it seeks to address unmet medical needs in infectious diseases.
Read more →VALN▼ -7%on this news
Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine
Valneva SE has commenced a Phase 2 clinical trial for its single-shot chikungunya vaccine, IXCHIQ®, with the first participant vaccinated. This trial aims to evaluate the safety and immunogenicity of the vaccine in children aged one to eleven, addressing a significant public health need as no approved chikungunya vaccine exists for this age group. The company's previous Phase 3 results demonstrated the vaccine's efficacy in adolescents and adults. The trial will involve around 300 healthy children across three sites in the Dominican Republic and Honduras, with the potential for extending the vaccine's accessibility to broader populations.
Read more →VALN▲ +5.4%on this news
Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum
Valneva SE has announced its participation in investor meetings at the upcoming J.P. Morgan Healthcare Conference and the Oddo BHF Forum. Key management members, including the CEO and CFO, will discuss their vaccine development pipeline, particularly highlighting VLA15 for Lyme disease and the FDA-approved IXCHIQ® vaccine against chikungunya. The company is focused on addressing unmet medical needs with its specialized vaccine development strategies. Investors are invited to schedule one-on-one meetings with Valneva's management to learn more about the growing commercial business and vaccine candidates.
Read more →VALN▲ +5.4%on this newsshared move
Unveiling the Lesser-Known Impact of Climate Change: The Rise of Mosquito-Borne Diseases
The article discusses the alarming rise of mosquito-borne diseases linked to climate change. It highlights how species like Aedes aegypti and Aedes albopictus are expanding their reach into new regions, posing a public health threat. Valneva emphasizes its commitment to developing vaccines to combat these diseases as climate change exacerbates the situation.
Read more →VALNValneva Provides Updated 2023 Financial Guidance
Valneva SE has updated its financial guidance for 2023, maintaining product sales estimates of €130 million to €150 million while pushing back expectations for €90 million to €110 million in other income related to the sale of its priority review voucher to early 2024. The company's recent approval of IXCHIQ®, the world's first chikungunya vaccine, is anticipated to enhance revenue as it prepares for a U.S. launch in early 2024. Additionally, R&D expenses have been lowered due to decreased costs linked to COVID-19 activities.
Read more →VALNValneva Shareholders Approve EGM Resolutions Including the Transition to a Board of Directors
Valneva SE announced that shareholders approved resolutions at its Extraordinary General Meeting on December 20, 2023, including the transition to a one-tier governance model. Anne-Marie Graffin was appointed Chair of the new Board of Directors, and Thomas Lingelbach was re-appointed as CEO. The company plans to propose additional board members in June 2024. Valneva is a specialty vaccine company in the process of advancing multiple vaccine candidates aimed at unmet medical needs.
Read more →VALN▲ +21.8%on this news· ran to +35% by day 1
EX-1 2 exhibit9912023_q1xresultsx.htm EX-1 Document VALNEVA SE Campus Bio-Ouest 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports First Quarter 2023 Financial Results and Provides Corporate Updates Produc
Valneva SE reported significant financial growth in the first quarter of 2023, with product sales increasing by 98.6% compared to the previous year, driven by strong performances from its vaccines. The company is advancing towards the potential launch of its chikungunya vaccine, with a PDUFA review goal set for August 2023, while also confirming its full-year revenue guidance. However, Valneva recorded a net loss, indicating challenges despite positive sales and operational momentum. The company continues to develop additional vaccine candidates and strengthen its portfolio.
Read more →VALNValneva Reports Full Year 2022 Results and Provides Corporate Updates
Valneva SE reported its financial results for the year ended December 31, 2022, showing total revenues of 361.3 million, driven largely by significant increases in product sales. The company has raised over 190 million in equity to bolster its cash reserves, while it expects total revenues for 2023 to be between 220 million and 260 million. Despite these positives, Valneva faced a net loss of 143.3 million and anticipates substantial R&D expenditures moving forward. The firm is focusing on advancing its chikungunya and Lyme disease vaccine candidates in 2023.
Read more →VALNValneva Reports Nine-Month 2022 Results and Provides Corporate Updates Total nine-month revenues of 249.9 million, a 3.5-fold increase compared to 2021 Product sales of 74.4 million (vs 45.5 million in the first nine mon
Valneva Reports Nine-Month 2022 Results and Provides Corporate Updates Total nine-month revenues of 249.9 million, a 3.5-fold increase compared to 2021 Product sales of 74.4 million (vs 45.5 million in the first nine months of 2021) driven by a continued recovery of travel vacc
Read more →VALN▼ -12.8%on this news
VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Announces the Pricing of 102.9 Million Global Offering of American Depositary Shares and Ordinary Shares Saint Herblain (France)
| 6, Rue Alain Bombard 44800 Saint-Herblain, Valneva Announces the Pricing of 102.9 Million Global Offering of American Depositary Shares and Ordinary Shares Saint Herblain (France), September 29, 2022 - Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the "Company"), a speci
Read more →VALNVALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Establishes an At-the-Market (ATM) Program on Nasdaq Saint-Herblain (France)
Campus Bio-Ouest | 6, Rue 44800 Saint-Herblain, France Valneva Establishes an At-the-Market (ATM) Program on Nasdaq (France), August 15, 2022 - Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has filed a prospectus supplemen
Read more →VALNVALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports H1 2022 Results and Provides Corporate Updates Excellent progress on late-stage clinical programs Lyme Disease Vaccine Candi
| 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports H1 2022 Results and Provides Corporate Updates progress on late-stage clinical programs Disease Vaccine Candidate VLA15 Chikungunya Vaccine Candidate VLA1553 marketing authorizations granted for inactivate
Read more →VALNVALNEVA SE - CONSOLIDATED FINANCIAL STATEMENTS 2022 1 CONSOLIDATED FINANCIAL STATEMENTS 2022 VALNEVA A European Company ( Societas Europaea ) with a Management and a Supervisory Board Registered offices: 6 rue Alain Bomb
ifrs-full:IssuedCapitalMember ifrs-full:SharePremiumMember ifrs-full:OtherReservesMember ifrs-full:RetainedEarningsExcludingProfitLossForReportingPeriodMember ifrs-full:RetainedEarningsProfitLossForReportingPeriodMember ifrs-full:IssuedCapitalMember ifrs-full:SharePremiumMe
Read more →VALNValneva SE Declaration of shares and voting rights - Interim status at June 22, 2022
Declaration of shares and voting rights Interim status at June 22, 2022 __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of
Read more →VALNValneva Initiates Heterologous Booster Trial of Inactivated, COVID-19 Vaccine Candidate
Valneva Initiates Heterologous Booster Trial of Inactivated, COVID-19 Vaccine Candidate Saint-Herblain (France), May 4, 2022 - Valneva SE, a specialty vaccine company, today announced the initiation of a heterologous booster trial of its inactivated whole-virus COVID-19 vaccine
Read more →VALN▼ -8.5%on this news
Valneva Reports Full Year 2021 Results and Provides Corporate Updates
Valneva Reports Full Year 2021 Results and Provides Corporate Updates Excellent progress on clinical programs Lyme Disease Vaccine Candidate VLA15 Further positive Phase 2 results, including booster response Phase 3 expected to commence in the third quarter of 2022 Inactivat
Read more →VALNVALNEVA SE Declaration of shares and voting rights - January 2022
Declaration of shares and voting rights __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of Euronext Paris - Compartment B D
Read more →VALN▼ -10.3%on this news
Valneva SE: declaration of shares and voting rights - November 2021
Declaration of shares and voting rights __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of Euronext Paris - Compartment B D
Read more →VALN▲ +39.8%on this news· ran to +60% by day 3
Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001 VLA2001 successfully met both co-primary endpoints Superior neutralizing antibody titer levels compared to active comparator vaccine, AstraZeneca's AZD1222 (ChAdOx1-S) Neutra
Read more →VALN▼ -11.1%on this news
Valneva Reports H1 2021 Financial Results and Provides Business Update
Valneva Reports H1 2021 Financial Results and Provides Business Update Key R&D Milestones Achieved Positive topline Phase 3 results for single-shot chikungunya vaccine candidate VLA1553 Protective neutralizing antibodies induced in 98.5% of trial participants Recruitment comp
Read more →VALNValneva Announces the Availability of Documentation for its Combined General Meeting to be held
Valneva Announces the Availability of Documentation for its Combined General Meeting to be held Saint-Herblain (France), June 2, 2021 - Valneva SE ("Valneva" or "the Company"), a specialty vaccine company focused on the development and commercialization of prophylactic vaccine
Read more →VALNto Participate in the World's First COVID-19 Vaccine Booster Trial in the UK
to Participate in the World's First COVID-19 Vaccine Booster Trial in the UK Saint-Herblain (France), May 19, 2021 - Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet
Read more →VALNVALNEVA Announces Signing of Marketing & Distribution Agreement for Seqirus' Flu vaccines Sandovac(R) and Fluad(R) in Austria
LYON, France, Aug. 25, 2016 (GLOBE NEWSWIRE) -- Valneva SE ("Valneva" or "the Company"), a leading pure play vaccine company, today announced the signing of an agreement with Seqirus, the second largest flu company in the world, for the marketing & distribution of Seqirus' season
Read more →VALNVALNEVA : European Investment Bank Grants Valneva a EU25 Million Loan to Fund R&D Activities
Signing of the finance contract by EIB Vice-President Ambroise Fayolle and Valneva's management board to take place today during a ceremony at the EIB's Paris offices Valneva will use the funds to advance its vaccine R&D programs, including its Lyme vaccine program which is expe
Read more →VALNVALNEVA Announces Successful Outcome of its AGM; Confirms its Growth Strategy and Financial Outlook
Valneva Announces Successful Outcome of its AGM; The Company Confirms its Growth Strategy and Financial Outlook New Supervisory Board appointed - consisting of five re-elected and three new members; Capital authorizations approved as proposed by the management board; During th
Read more →VALNVALNEVA Appoints Two Leading Pharma Executives to its Supervisory Board
Valneva Appoints Two Leading Pharma Executives to its Supervisory Board LYON, France, July 1, 2016 (GLOBE NEWSWIRE) -- Valneva SE ("Valneva" or "the Company"), a leading pure play vaccine company, today announced the appointment of Ralf Clemens, former Head of Global Vaccine Dev
Read more →VALNVALNEVA : First sales of Flu Vaccines Produced on Valneva's EB66(r) Cell-Line
First sales of Flu Vaccines Produced on Valneva's EB66 Cell-Line Valneva to begin receiving royalties for an EB66 -based human vaccine in 2016 LYON, France, June 13, 2016 (GLOBE NEWSWIRE) -- Valneva SE ("Valneva" or "the Company"), a leading pure play vaccine company, announces
Read more →VALNVALNEVA Announces $42 Million IXIARO(R) Supply Contract with US Government
LYON, France, March 16, 2016 (GLOBE NEWSWIRE) -- Valneva SE ("Valneva" or "the Company"), a leading pure play vaccine company, announces today the signing of a $42 million contract with the US Government's Department of Defense for the supply of its Japanese encephalitis (JE) vac
Read more →VALNValneva Posts 96% Revenue Growth in 2015; Forecasts 2016 Revenues of EU90 to EU100 Million
Valneva Posts 96% Revenue Growth in 2015; Forecasts 2016 Revenues of 90 to 100 Million The Company today announced its unaudited FY 2015 revenues, unaudited year-end cash balance and 2016 outlook Revenues and grants increased by 96% year-on-year and amounted to 83.3 million in
Read more →VALNVALNEVA Signs New R&D Collaboration with GlaxoSmithKline for the EB66(r) Cell Line
Valneva to supply process development services for EB66 -based Influenza vaccines Advanced Development program sponsored by the US Department of Health and Human Services Valneva to receive research fees under the new agreement LYON, France, Feb. 8, 2016 (GLOBE NEWSWIRE) -- Va
Read more →VALNVALNEVA provides update on DUKORAL(R) vaccine in Canada
Business transition and integration of the newly acquired DUKORAL and Nordics vaccine distribution business largely completed Health Canada requested changes to product monograph for DUKORAL in Canada Valneva and the seller agree on modifications to the purchase agreement inclu
Read more →VALNVALNEVA Announces U.S. Distribution and Marketing Services Agreements with VaxServe for Japanese Encephalitis Vaccine IXIARO(R)
LYON, France, Nov. 9, 2015 (GLOBE NEWSWIRE) -- Valneva SE ("Valneva"), a leading pure-play vaccine company, announced today that its fully owned US subsidiary Intercell USA, Inc. has entered into distribution and marketing services agreements with VaxServe, Inc. ("VaxServe"), a S
Read more →VALNVALNEVA Valneva Announces Two New EB66(R) Agreements
Valneva signs two new EB66 agreements with Italian firm Fatro (commercial license) and Japanese pharmaceutical company Kaketsuken (research license) The Company which has already signed seven new EB66 deals since the beginning of the year expects to sign additional EB66 agreemen
Read more →VALNVALNEVA takes direct control over Marketing & Distribution of IXIARO(R) to increase margin and profitability
In support of the company's strategy to build a leading, independent and fully integrated vaccines biotech company, and to leverage synergies with its recently acquired second travel vaccine and distribution infrastructure, Valneva has terminated the IXIARO -related Marketing & D
Read more →VALNVALNEVA announces signing of an exclusive license agreement on EB66(r) Cell Line for Human and Veterinary Vaccines in China
LYON, France, March 17, 2015 (GLOBE NEWSWIRE) -- Valneva announces signing of an exclusive license agreement on EB66 Cell Line for Human and Veterinary Vaccines in People's Republic of China The partner Jianshun Biosciences Ltd is granted exclusive rights to commercialize the EB
Read more →VALNValneva SE announces the sale of its Clinical Manufacturing Operations (CMO) in France to Biological E
Valneva SE announces the sale of its Clinical Manufacturing Operations (CMO) in France to Biological E Next step in broadening an excellent strategic partnership Lyon (France), Hyderabad (India) 7th June, 2013 - Valneva SE (Valneva), a European biotech company, today announced
Read more →Competitive Position
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