Valneva SE, a specialty vaccine company, focuses on the development and commercialization of prophylactic vaccines for infectious diseases with unmet needs. Its commercial vaccines for travelers include IXIARO, an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis; DUKORAL, an oral vaccine for the prevention of diarrhea caused by Vibrio cholera and/or heat-labile toxin producing Enterotoxigenic Escherichia coli bacterium; and VLA2001, a vaccine candidate against SARS-CoV-2. The company also develops VLA15, a vaccine candidate that has completed Phase II clinical trial against Borrelia; and VLA1553, a vaccine candidate, which is in Phase III clinical trial against the chikungunya virus. It sells its products in the United States, Canada, Germany, Austria, Nordics, the United Kingdom, other European countries, and internationally. Valneva SE has collaborations with Pfizer, Inc. to co-develop and commercialize its Lyme disease vaccine; and Instituto Butantan for the development, manufacturing, and marketing of single-shot chikungunya vaccine. The company was founded in 1998 and is headquartered in Saint-Herblain, France.
IPO Year: 2021
Exchange: NASDAQ
Website: https://valneva.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 8/3/2022 | $34.00 | Buy | H.C. Wainwright |
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Saint Herblain (France), April 18, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that during its regular meeting on April 16, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) updated its recommendation for use of Valneva's single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV). ACIP maintained its current recommendation for IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons aged ≥18 years traveling or taking up residence in a cou
Saint-Herblain (France), April 16, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced its presence at the forthcoming 25th World Vaccine Congress, which will take place from April 21-24, 2025 at the Walter E. convention center in Washington, D.C. Under the leadership of the Company´s Chief Executive Officer, Thomas Lingelbach, a team of Valneva´s senior managers will participate in multiple events, including an important presentation on the Company´s vaccine IXCHIQ®, the world's first licensed chikungunya vaccine. The Company will have a display in the exhibit area of the congress at booth #424. On April 22, from 11:40am to 12:20pm EST, Valneva's Chief
Saint Herblain (France), April 14, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to its single-dose vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The ANVISA decision marks the world's first approval of a chikungunya vaccine in an endemic country. Part of Valneva's endemic country strategy, this endeavor is supported by the Coalition for Epidemic Preparedness Innovations (CEPI)1, with co-funding from the European Union (EU), and Instituto Butantan2 to support broader access to a chikungunya
Saint Herblain (France) and Schlieren (Zurich), April 9, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2 infant safety and immunogenicity study of Shigella4V2 (S4V2), the world's most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis. Shigellosis is the second leading cause of fatal diarrheal disease worldwide, strongly contributing to pediatric morbidity and mortality. It is estimated that up to 165 million infections are due to S
With this extension, IXCHIQ®, the first vaccine against the chikungunya virus (CHIKV), is now available for administration for individuals 12 years of age and older in the European Union (EU). Saint Herblain (France), April 1, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva's single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 12 years of age and older. This label extension complements the adult marketing authorization in Europe Valneva received in July 20241. With this approval, IXCHIQ® becomes available
Saint Herblain (France), March 31, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ®, currently approved in adults1, to adolescents aged 12 to 17 years in the UK. This submission follows the recent positive opinion of the European Medicines Agency (EMA) on extension of IXCHIQ® label to adolescents in the European Union (EU)2. IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It i
Saint-Herblain (France), March 26, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA) ("Valneva" or the "Company"), a specialty vaccine company, today announces that it has filed a prospectus supplement as part of the renewal of its registration statement on Form F-3, filed on March 25, 2025 with the U.S. Securities and Exchange Commission ("SEC") relating to its existing At-the-Market offering facility (the "ATM Program"), which was originally entered into in August 2022 and has not been utilized to-date. Pursuant to this financing program, the Company has the option to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $75.0 million
Saint-Herblain (France), March 25, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, announced today the filing, on March 24, 2025, of its 2024 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.25-0140 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC). Valneva's 2024 Universal Registration Document – available in its entirety in French – includes the Company's 2024 Annual Financial Report, the Company's Annual Management Report, the Board of Directors' Corporate Governance Report and the Company's Sustainability Statement. The Sustainability Statement is available in both English an
Saint Herblain (France), March 24, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France's Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the Island's wholesalers. This supply of doses, paid for by the French authorities, is in line with the recommendation of France's national public health agency, the Haute Autorité de Santé (HAS), to prio
Met 2024 growth targets for product sales (+13% vs 2023) and total revenues (+10% vs 2023)Strong year-end cash position of €168.3 million including sale of Priority Review Voucher1, successful private placement and 67% reduction in operating cash burnSubstantial clinical and regulatory progress in 2024; further data readouts, product approvals and label extensions anticipated in 20252025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), March 20, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its consolidated financial results for the y
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H.C. Wainwright initiated coverage of Valneva SE with a rating of Buy and set a new price target of $34.00
Met 2024 growth targets for product sales (+13% vs 2023) and total revenues (+10% vs 2023)Strong year-end cash position of €168.3 million including sale of Priority Review Voucher1, successful private placement and 67% reduction in operating cash burnSubstantial clinical and regulatory progress in 2024; further data readouts, product approvals and label extensions anticipated in 20252025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), March 20, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its consolidated financial results for the y
Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidan
First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasingNet Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarterSignificantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial
Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates Q1 financial highlights Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated full year guidance Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV)1. Significantly extended cash runway with recent update of debt financing agreement2Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter Net Profit of €58.9 million, reflecting PRV sale 2024 financial guidance confirmed Expected tot
Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26%Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million from sale of Priority Review Voucher (PRV)1 Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway2Operational business considered sufficiently funded (excluding debt repayment) until commercial revenues from Lyme program enable sustained profitability Excellent progress across R&D pipeline Appr
Product sales of €106.1 million, an increase of 42.6% compared to the first nine months of 2022 IXIARO® and DUKORAL® sales benefited from a continued recovery of the travel industryTotal revenues of €111.8 million in the first nine months of 2023 Cash position of €171.3 million as of September 30, 2023 Includes $50 million of the $100 million available following upsize of credit facility with leading U.S. Healthcare Funds Deerfield and OrbiMed in August 20231Includes a significant payment made to Pfizer in the third quarter of 2023 related to the companies' Phase 3 Lyme disease study "VALOR" Chikungunya: progressing towards potential licensure of the world's first chikungunya vacci
Product sales more than doubled in the first half of 2023 to €69.7 million compared to €33.3 million in the first half of 2022 Driven by IXIARO® and DUKORAL® sales, both of which benefited from a continued recovery of the travel industry as well as from price increasesBringing total revenues to €73.7 million in the first half of 2023 Strong cash position of €204.4 million as at June 30, 2023 Excludes up to an additional $100 million made available as part of a recent upsized financing arrangement with leading U.S. Healthcare Funds Deerfield and OrbiMed1 Chikungunya: progressing towards delivery of the world's first chikungunya vaccine Biologic License Application (BLA) current
Saint-Herblain (France), August 31, 2023 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023. The Company will discuss its single-dose vaccine candidate against the chikungunya virus (VLA1553), currently under priority review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) action date planned for end of November 20231, as well as its Lyme disease vaccine candidate (VLA15), which is currently in Phase 3 clinical trials led by Valneva's development partner Pfizer. The Comp
Product sales increased 98.6% to €32.1 million in the first quarter of 2023 compared to €16.2 million in the first quarter of 2022 Driven by IXIARO® and DUKORAL® sales both of which more than quadrupled year-over-yearTotal revenues of €33.5 million in the first quarter of 2023 compared to €21.8 million in the first quarter of 2022 Strong cash position of €254.5 million at March 31, 2023 Chikungunya: progressing towards delivery of the world's first chikungunya vaccine Prescription Drug User Fee Act (PDUFA) review goal date confirmed for end of August 2023 by the U.S. Food and Drug Administration (FDA) Additional regulatory submission process to be initiated in the second quarter of 2023
Excellent progress on clinical programs Lyme Disease Vaccine Candidate VLA15 Further positive Phase 2 results reported, including first pediatric data Phase 3 expected to commence in the third quarter of 2022 Inactivated COVID-19 Vaccine Candidate VLA2001 Conditional Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK)Emergency use authorization granted by the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain and first vaccinations confirmed Rolling review ongoing with the European Medicines Agency (EMA); Valneva has provided responses to the latest list of questions (LOQ) Single-Shot Chiku
Saint-Herblain (France), June 26, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2023 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment of a new director to its Board. Ms. Danièle Guyot-Caparros was appointed to Valneva's Board of Directors for a three-year term. Ms. Guyot-Caparros has a proven track record in finance and business
Saint-Herblain (France), May 21, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024. Valneva decided to complement its Executive Team with an accomplished R&D leader to oversee the further evolution of the Company´s R&D portfolio. Specifically, Dr. Schuitemaker will focus on accelerating Valneva's pre-clinical and translational R&D activities in support of the Company's strategic ambition to provide first-, best- or only-in-class vaccine solutions. Dr. Schuitemaker brings more than two decades of experience in vacc
Saint-Herblain (France), June 21, 2023 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2022 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, as well as the appointment of a new Supervisory Board member and the reappointment of two of them. Dr Kathrin U Jansen, Ph.D., a German national with over 30 years of vaccine R&D experience, was appointed to Valneva's Supervisory
Saint-Herblain (France), November 17, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the appointment of Dipal Patel as Chief Commercial Officer (CCO) and Management Board member. With this newly created role, Valneva strengthens its management team with a recognized commercial industry leader as the Company advances its chikungunya vaccine candidate towards potential market entry in 2023. Ms. Patel is an established commercial leader with over 23 years of experience in the pharmaceutical sector covering commercial strategy, execution, market access and lifecycle management. Over her career, she has held roles of increasing responsibilities across mu
Saint-Herblain (France), June 24, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held yesterday in Paris. Among the adopted resolutions were approval of the 2021 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment, for a three-year term, of two new Supervisory Board members. Bpifrance Participations was appointed to Valneva's Supervisor Board and will be represented by Maïlys Ferrère. Ms. Ferrère, a French national, is
Saint-Herblain (France), May 31, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, announced today the appointment of leading vaccine experts Dr. Thomas Decker and Dr. Michael Pfleiderer to its Scientific Advisory Board (SAB). Dr. Thomas Decker is a professor of Immunobiology at the Max Perutz Labs of the University of Vienna. His experience as an immunobiologist stems from more than 30 years of research and teaching in Germany, Sweden, Austria and the USA, with a focus on the molecular aspects of immunity to infection. During his career, Dr. Decker also served as a consultant for several pharmaceutical companies. He was Chair of the Department of Microbiology and Gen
ShouTi Inc., a clinical-stage global biopharmaceutical company developing novel oral therapeutics to treat a wide range of chronic diseases, today announced the appointment of Sharon Tetlow to the company's board of directors. Ms. Tetlow will also serve as chair of the audit committee. "On behalf of the board and management team at ShouTi, I am pleased to welcome Sharon to the board," said Daniel Welch, Chairman of the Board, ShouTi. "Sharon is an accomplished life sciences finance executive whose deep financial strategy and compliance expertise will be instrumental in leading our audit committee. With an outstanding track record of advising biopharmaceutical companies, Sharon's perspectiv