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 ...

Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ , to UK MHRA ® Saint Herblain (France), March 31, 2025 – Valneva SE (Nasdaq: VALN; Euronext 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 adults , to adolescents aged 12 to 17 ...

Core Insights - Valneva SE has submitted a label extension application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) to expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years, following a positive opinion from the European Medicines Agency (EMA) for the same extension in the EU [1][2]. Company Developments - IXCHIQ® is the world's first licensed chikungunya vaccine, currently approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK [2][3]. - Valneva has committed to supplying 40,000 doses of IXCHIQ® to La Réunion, responding to a call from the French government amid ongoing chikungunya outbreaks [3][4]. - The company is focused on expanding the vaccine's accessibility, with positive Phase 3 data showing a 99.1% immune response in adolescents after a single dose, and a sustained 98.3% sero-response rate one year post-vaccination [4][5]. Partnerships and Funding - In Q3 2024, Valneva expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) through a $41.3 million grant aimed at increasing vaccine access in low- and middle-income countries (LMICs) [5][6]. - An exclusive license agreement was signed with the Serum Institute of India to supply IXCHIQ® in Asia, ensuring affordable pricing for public health markets in LMICs [6][7]. - Valneva previously established a license agreement with Instituto Butantan in Brazil for a local chikungunya vaccine, further enhancing its distribution capabilities in Latin America [7]. Public Health Context - Chikungunya has emerged as a significant public health concern, with outbreaks reported in India, Brazil, and La Réunion, and the World Health Organization (WHO) has identified it as a major public health problem [3][9]. - The chikungunya virus has been reported in over 110 countries since its re-emergence in 2004, with over 3.7 million cases documented in the Americas between 2013 and 2023 [9].

On February 25, 2025, the U.S. Centers for Disease Control and Prevention ("CDC") posted a notice on its website announcing that "CDC is currently investigating five hospitalizations for cardiac or neurologic events following vaccination with IXCHIQ [Valneva's chikungunya virus vaccine] among people 65 years of age and older." Following the CDC's announcement and subsequent reporting by media outlets, Valneva's American Depositary Receipt ("ADR") price fell $1.06 per ADR, or 13.57%, over the following four ...

Core Viewpoint - Valneva SE has filed a prospectus supplement to renew its registration statement for an At-the-Market (ATM) offering program, allowing it to sell up to $75 million of American Depositary Shares (ADS) [1][2]. Group 1: ATM Program Details - The ATM Program allows Valneva to offer and sell ADSs representing two ordinary shares, with a total gross amount of up to $75 million [2]. - The program was originally established in August 2022 but has not been utilized to date [1]. - The Sales Agreement with Jefferies LLC will remain in effect until the maximum amount is reached or terminated early [2]. Group 2: Use of Proceeds - Valneva intends to use the net proceeds from the ATM Program to fund manufacturing, commercialization, research and development of its products, working capital, and other general corporate purposes [5]. Group 3: Regulatory and Market Information - The ADSs are listed on the Nasdaq Global Market under the symbol "VALN," while the ordinary shares are listed on Euronext Paris under the symbol "VLA" [4]. - The ADSs will be issued under a shelf registration statement on Form F-3, which is pending effectiveness by the SEC [3][12]. Group 4: Share Capital Increase - The issuance of ADSs may occur through share capital increases without preferential subscription rights, with a maximum of 7,666,666 ordinary shares available for issuance [7]. - This represents a potential dilution of approximately 4.5% based on the existing share capital [7]. Group 5: Investor Eligibility - The ATM Program is available only to qualified investors, including individuals and entities involved in the pharmaceutical and biotechnology sectors [9][10].

Core Points - Valneva SE, a specialty vaccine company, 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 on March 24, 2025 [1] - The 2024 Universal Registration Document includes the Company's Annual Financial Report, Annual Management Report, Corporate Governance Report, and Sustainability Statement [2] - These documents are accessible on Valneva's website and will also be available on the AMF and SEC websites [3] Company Overview - Valneva SE focuses on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [4] - The company has successfully advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines, including the world's first chikungunya vaccine [5] - Revenues from the commercial business support the advancement of the vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development partnered with Pfizer and the most clinically advanced Shigella vaccine candidate [6]