Core Insights - Valneva SE announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial of the chikungunya vaccine IXCHIQ in children, supporting the initiation of a pivotal Phase 3 study in early 2026 [1][2][8] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, with a strong track record in advancing multiple vaccines from early R&D to approvals [10][11] - The company currently markets three proprietary travel vaccines, including the world's first and only chikungunya vaccine, and has a pipeline that includes candidates for Lyme disease, Shigella, and Zika virus [12] Clinical Trial Results - The Phase 2 trial (VLA1553-221) involved 304 healthy children aged one to eleven years, demonstrating that a full dose of the vaccine elicited a more robust immune response compared to a half dose, with a 96.5% seroresponse rate at Day 180 [2][3][8] - The vaccine was well tolerated across all age groups tested, with no safety concerns identified, supporting the selection of the full dose for the upcoming Phase 3 trial [4][5][8] Market Context - Chikungunya poses a significant health risk, particularly in endemic areas, with Brazil reporting over one million cases from January 2019 to July 2024, and India reporting 370,000 cases during the same period [5][7] - The World Health Organization has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change and the geographical spread of mosquito vectors [7]

Core Insights - Valneva SE, a specialty vaccine company, is set to present and hold investor meetings at various conferences in the US and Europe in June 2025 [1][2] Group 1: Upcoming Conferences - Valneva will participate in the Jefferies Global Healthcare Conference on June 5, 2025, in New York, featuring a fireside chat and investor meetings [4] - The company will also attend the Goldman Sachs 46th Annual Global Healthcare Conference on June 9, 2025, in Miami, FL, with a similar format [4] - Additionally, Valneva will engage in investor meetings at the Oddo BHF Nextcap Forum on June 12, 2025, and the BNP Paribas SMID Cap Conference on June 18, 2025, in Paris, France [5][6] Group 2: Key Discussion Topics - The discussions will focus on Valneva's commercial stage vaccines and its differentiated portfolio, particularly VLA15, which is the leading Lyme disease vaccine candidate partnered with Pfizer [2][8] - VLA15 is currently undergoing a pivotal Phase 3 trial, with the company expecting to release the first data by the end of 2025 [2] Group 3: Company Overview - Valneva specializes in developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] - Valneva's pipeline includes the only Lyme disease vaccine candidate in advanced clinical development, the world's most clinically advanced Shigella vaccine candidate, and candidates against the Zika virus and other public health threats [8]

Core Viewpoint - Valneva SE reported strong financial results for Q1 2025, with significant revenue growth and reduced operational cash burn, while confirming its financial guidance for the year [3][5][6]. Financial Performance - Total revenues for Q1 2025 were €49.2 million, a 50.3% increase from €32.8 million in Q1 2024 [5][6]. - Product sales reached €48.6 million, up 51.2% from €32.1 million in the same period last year [6][31]. - The company reported a net loss of €9.2 million compared to a net profit of €58.9 million in Q1 2024, which included €90.8 million from the sale of a Priority Review Voucher [6][45]. - Operating cash burn was reduced by 71% to €8.1 million in Q1 2025 from €28.4 million in Q1 2024 [6][47]. - Cash and cash equivalents stood at €153.0 million as of March 31, 2025, down from €168.3 million at the end of 2024 [6][50]. Product Sales and Market Developments - IXIARO®/JESPECT® sales increased by 65.5% to €27.5 million, driven by demand from travelers and the U.S. Department of Defense [10][32]. - DUKORAL® sales grew 9.4% to €12.3 million, supported by a supply agreement with the French government [12][33]. - IXCHIQ® sales surged to €3.0 million from €0.2 million in Q1 2024, with initial sales related to a chikungunya outbreak response [13][34]. - Third-party product sales increased to €5.8 million from €4.1 million, reflecting recovery from previous supply constraints [18][35]. Research and Development Highlights - Valneva is advancing its Lyme disease vaccine candidate, VLA15, with primary vaccinations completed and data expected by the end of 2025 [20][21]. - The company is also developing a tetravalent Shigella vaccine candidate, S4V2, with ongoing Phase 2 studies [23][24]. - A Phase 1 trial for a Zika vaccine candidate, VLA1601, is currently underway, with results anticipated this year [28][29]. Strategic Partnerships and Regulatory Progress - Valneva secured a $32.8 million supply contract for IXIARO® with the U.S. Department of Defense [7][11]. - The company received marketing authorization for IXCHIQ® in the UK and Brazil, marking significant milestones for its chikungunya vaccine [7][14][15]. - Valneva has entered into a licensing agreement with the Serum Institute of India to expand access to its chikungunya vaccine in Asia [15][61]. Financial Outlook - The company expects product sales to grow to €170-180 million in 2025, with total revenues projected to reach €180-190 million [6][5]. - R&D investments are anticipated to be between €90-100 million in 2025, partially offset by grant funding and tax credits [6][5].

Core Points - The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) updated its recommendation for Valneva's chikungunya vaccine IXCHIQ®, maintaining its use for travelers aged ≥18 to chikungunya outbreak areas and considering it for those in elevated risk areas for extended stays [1][2] - ACIP recommended a precaution for IXCHIQ® use in individuals aged ≥65 due to ongoing investigations of serious adverse events (SAEs) reported in older vaccinated individuals [2][3] - Valneva has supplied approximately 80,000 doses of IXCHIQ® across the U.S., Canada, and Europe, with no new SAEs reported since January 2025, and ongoing safety monitoring has not identified any safety signal concerns inconsistent with the U.S. product label [5] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, including the world's first chikungunya vaccine [9][10] - The company has a strong track record in advancing vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [10][11] - Revenues from Valneva's commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [11] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease causing significant health issues, with over 3.7 million cases reported in the Americas between 2013 and 2023 [7][8] - The World Health Organization (WHO) has identified chikungunya as a major public health problem, with the disease's economic impact expected to grow due to climate change [8]

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]

Core Insights - Valneva's shares increased by 12% following the announcement of the first participant vaccinated in a phase II study for its Shigella vaccine, S4V2 [1] - The study aims to evaluate the safety and immunogenicity of S4V2 in approximately 110 infants, with results expected in the second half of 2025 [2] Company Overview - Valneva is developing S4V2 to address shigellosis, a significant global health issue, particularly affecting children in low and middle-income countries, with an estimated 165 million infections annually [3] - The company has initiated a second mid-stage study for S4V2, building on positive data from a previous phase I/II study that demonstrated a favorable safety profile and robust immunogenicity [7][8] Market Potential - The rise in Valneva's stock price reflects growing investor optimism regarding the commercial potential of S4V2, especially given the lack of approved vaccines for shigellosis [4] - The FDA's fast track designation for S4V2 indicates increased regulatory support, which may expedite the vaccine's development and review process [4] Financial Performance - Year-to-date, Valneva's shares have surged by 55%, contrasting with a 4% decline in the broader industry [5]

Core Insights - Valneva SE and LimmaTech Biologics AG have initiated a Phase 2 infant safety and immunogenicity study for Shigella4V2 (S4V2), a tetravalent bioconjugate vaccine candidate against shigellosis, marking a significant step in vaccine development [1][3][4] Industry Overview - Shigellosis is the second leading cause of fatal diarrheal disease globally, with an estimated 165 million infections annually, of which 62.3 million occur in children under five years [2][6] - The disease results in approximately 600,000 deaths each year, highlighting the urgent need for an effective vaccine [6] Study Details - The Phase 2 study (Identifier: NCT06523231) will involve around 110 nine-month-old infants to determine the optimal vaccine dosage for future Phase 3 trials [3] - The study is randomized, controlled, and blinded, taking place at a single site in Kenya, with results expected in the second half of 2025 [3] Company Statements - Dr. Juan Carlos, Chief Medical Officer of Valneva, emphasized the unacceptable mortality rates from shigellosis and the company's commitment to developing vaccines for unmet medical needs [4] - Dr. Patricia Martin, COO of LimmaTech, highlighted the trial's initiation as a significant milestone in their collaboration with Valneva to address this global health threat [4] Regulatory Status - The U.S. FDA has granted Fast Track designation to S4V2, recognizing its potential to address a serious health condition and fill an unmet medical need [5]

Core Viewpoint - The Schall Law Firm is investigating Valneva SE for potential violations of securities laws related to misleading statements and undisclosed information concerning its chikungunya virus vaccine, IXCHIQ [1][2]. Group 1: Investigation Details - The investigation centers on whether Valneva issued false or misleading statements or failed to disclose critical information to investors [2]. - A CDC notice dated February 25, 2025, indicates an investigation into five hospitalizations for cardiac or neurologic events following vaccination with IXCHIQ among individuals aged 65 and older [2]. - Following the CDC notice, Valneva's American Depositary Receipt (ADR) price dropped by over 13.5% in subsequent trading sessions [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who have experienced losses are encouraged to contact the firm for a free discussion of their rights [3].

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 individ ...

Saint Herblain (France), April 1, 2025 – Valneva SE (Nasdaq: VALN; Euronext 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 avail ...