U.S. stock futures were lower this morning, with the Dow futures falling around 0.2% on Tuesday.Shares of EHang Holdings Ltd – ADR EH fell sharply in pre-market trading after the company reported second-quarter results and cut its FY2025 sales guidance.EHang cut its FY2025 sales outlook from $123.299 million to $69.797 million.EHang shares dipped 8.5% to $16.27 in the pre-market trading session.Here are some other stocks moving lower in pre-market trading.Molecular Partners AG MOLN fell 13.5% to $3.65 in th ...

U.S. stocks were mixed, with the Dow Jones index falling more than 200 points on Monday.Shares of Keurig Dr Pepper Inc. KDP fell sharply during Monday's session after the company announced the acquisition of JDE Peet’s.Keurig Dr Pepper shares dipped 7.8% to $32.38 on Monday.Here are some other big stocks recording losses in today’s session.Valneva SE VALN shares fell 21% to $9.19 after the FDA suspended the license for IXCHIQ.DeFi Development Corp. DFDV dipped 18% to $16.51 after the company announced that ...

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs [2] Financial Impact - IXCHIQ sales contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] Commitment to Safety and Access - Valneva is committed to maintaining high safety standards and will continue to engage with health authorities regarding IXCHIQ [3] - The CEO emphasized the company's commitment to providing access to IXCHIQ globally, especially in low-and-middle-income countries affected by chikungunya outbreaks [4] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, indicating the ongoing need for effective vaccines [6]

Core Insights - Valneva SE has received marketing authorization from Health Canada for its single-dose chikungunya vaccine, IXCHIQ, for individuals aged 12 years and older, complementing previous authorizations in Canada and Europe [1][3][10] - The vaccine demonstrates a sustained immune response for 24 months in 97% of participants, indicating its long-term efficacy [2][5] - The approval is significant as chikungunya outbreaks are increasing globally, particularly in endemic regions, highlighting the need for accessible vaccination [3][4][5] 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 vaccines from R&D to market [7] - The company currently markets three proprietary travel vaccines and is advancing multiple vaccine candidates, including those for Lyme disease and Zika virus [7] Industry Context - Chikungunya virus is a mosquito-borne disease causing severe joint pain and other debilitating symptoms, with over 3.7 million cases reported in the Americas from 2013 to 2023 [6] - The World Health Organization has identified chikungunya as a major public health issue, exacerbated by climate change and the geographical spread of mosquito vectors [6] - Valneva's partnership with CEPI aims to enhance access to IXCHIQ in low- and middle-income countries, addressing the growing public health threat posed by chikungunya [4][5]

Core Points - The FDA has lifted the recommended pause on the use of IXCHIQ for individuals aged 60 and older, following a thorough review by the European Medicines Agency (EMA) [1][2] - IXCHIQ is indicated for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years and older at high risk of exposure [1][2] - The product's prescribing information has been updated to include reports of serious adverse events, particularly among elderly individuals with multiple underlying health conditions [2][4] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] - Revenues from the commercial business support the advancement of the vaccine pipeline, including candidates for Lyme disease, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has caused significant outbreaks globally, with over 3.7 million cases reported in the Americas between 2013 and 2023 [6] - The World Health Organization (WHO) has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change [6]

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [6] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [7] - Revenues from its growing commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [8] Industry Context - The chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant outbreaks reported since 2004 [5] - Between 2013 and 2023, more than 3.7 million chikungunya cases were reported in the Americas, indicating a substantial medical and economic burden [5] - The World Health Organization (WHO) has recognized chikungunya as a major public health problem, with the impact expected to grow due to climate change [5] Regulatory Update - The European Medicines Agency (EMA) has lifted the temporary restriction on vaccinating individuals aged 65 and above with Valneva's chikungunya vaccine IXCHIQ after a thorough safety review [1][2] - The EMA concluded that IXCHIQ should be administered when there is a significant risk of chikungunya infection, considering the benefits and risks for all age groups [2][3] - IXCHIQ was authorized in the European Union in June 2024, with a label extension granted in March 2025 for adolescents aged 12 and older [3]

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]

Financial Performance - Valneva reported total revenues of €49.2 million for Q1 2025, a 50.3% increase from €32.8 million in Q1 2024 [8][28] - Product sales reached €48.6 million, up 51.2% from €32.1 million in the same period last year [8][28] - The company incurred a net loss of €9.2 million in Q1 2025, 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 [8][42] - Adjusted EBITDA loss was €0.6 million in Q1 2025, down from a profit of €73.0 million in Q1 2024 [8][41] - Operating cash burn was reduced by 71% to €8.1 million in Q1 2025 from €28.4 million in Q1 2024 [8][44] Product Sales and Growth - Sales of the Japanese Encephalitis vaccine IXIARO/JESPECT increased by 65.5% to €27.5 million in Q1 2025, driven by demand from travelers and the U.S. Department of Defense [6][29] - DUKORAL sales grew 9.4% to €12.3 million, supported by a supply agreement with the French government [9][30] - IXCHIQ sales rose significantly to €3.0 million from €0.2 million in Q1 2024, with most doses shipped in April 2025 [10][30] Cash Position and Financial Outlook - Cash and cash equivalents stood at €153.0 million as of March 31, 2025, down from €168.3 million at the end of 2024 [8][47] - The company confirmed its financial guidance for 2025, expecting product sales to grow to €170-180 million and total revenues to reach €180-190 million [2][8] - Total R&D investments are projected between €90-100 million for 2025, partially offset by grant funding and anticipated R&D tax credits [8] Clinical and Regulatory Developments - Valneva is anticipating the first data from its Lyme disease Phase 3 program by the end of 2025 [2] - The company received marketing authorization for IXCHIQ in the UK and Brazil, marking significant milestones for its chikungunya vaccine [11][12] - IXCHIQ has also received label extensions in the EU for adolescents and is under review in multiple countries [11][12] Strategic Partnerships and Future Plans - Valneva has entered into an exclusive license agreement with the Serum Institute of India to supply its chikungunya vaccine in Asia [12] - The company is focusing on ramping up sales and expanding its vaccine portfolio in additional countries [11] - Valneva aims to reduce third-party sales to less than 5% of overall product sales by 2026/2027 to improve gross margins [16]

Core Points - Valneva SE's chikungunya vaccine IXCHIQ has faced updated recommendations from France's Haute Autorité de Santé (HAS) due to serious adverse events reported in elderly individuals with comorbidities during the vaccination campaign in La Reunion and Mayotte [1][2] - The French health authorities have suspended the use of IXCHIQ for individuals aged 65 and older while maintaining its recommendation for those aged 18 to 64 [2] - Valneva has supplied 40,000 doses of IXCHIQ to La Reunion amid a significant chikungunya outbreak with approximately 40,000 confirmed cases since the start of 2025 [1][4] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record in advancing vaccines from early research and development to approvals, currently marketing three proprietary travel vaccines [8] - Valneva's revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [6] - The World Health Organization (WHO) has recognized chikungunya as a major public health problem, highlighting the need for effective vaccines and interventions [6]

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].