Valneva(VALN)

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Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences
Newsfilter· 2025-03-03 06:00
Core Viewpoint - Valneva SE, a specialty vaccine company, is actively engaging with investors through upcoming conferences in the U.S. and Europe, highlighting its vaccine pipeline and revenue expectations for 2025 [1][2]. Company Overview - Valneva SE develops, manufactures, and commercializes prophylactic vaccines for infectious diseases, focusing on unmet medical needs and employing a specialized approach across various vaccine modalities [3]. - The company has a strong track record of advancing multiple vaccines from early R&D to approvals, currently marketing three proprietary travel vaccines, including the world's first chikungunya vaccine [4]. Financial Expectations - Valneva's marketed vaccines are projected to generate revenue between €170 million and €180 million in 2025 [2][5]. - The revenue from the commercial business supports the advancement of the vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development, partnered with Pfizer, and other candidates targeting global public health threats [5]. Upcoming Events - Valneva's CEO and CFO will present at the TD Cowen 45th Annual Health Care Conference in Boston from March 3-5, 2025, and will also meet with institutional investors at the Van Lanschot Kempen Life Sciences Conference in Amsterdam on April 2-3, 2025 [1][2]. - The TD Cowen presentation will be available via live webcast [2].
Valneva Receives EMA's Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ®
GlobeNewswire News Room· 2025-02-28 16:45
Core Viewpoint - Valneva SE's IXCHIQ® vaccine is recommended for authorization to extend its use to adolescents aged 12 and older in the EU, marking a significant step in combating chikungunya virus (CHIKV) [1][2][4] Company Developments - Valneva received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for IXCHIQ®, which is already authorized for individuals 18 years and older since July 2024 [1][2] - The company plans to submit additional label extension applications to the U.S. FDA and Health Canada for the use of IXCHIQ® in adolescents [4] - Valneva has expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) through a $41.3 million grant to enhance vaccine access in low- and middle-income countries [5][6] Clinical Data - Phase 3 data indicated that IXCHIQ® induces a high immune response in 99.1% of adolescents, with a sustained immune response in 98.3% one year post-vaccination [3] - The vaccine was reported to be generally safe and well tolerated in adolescents aged 12 to 17 years [3][4] Market Context - Chikungunya virus has been identified in over 110 countries, with significant economic and medical burdens expected to grow due to climate change [10] - The World Health Organization (WHO) has recognized chikungunya as a major public health issue, highlighting the need for effective vaccines [10] Strategic Partnerships - Valneva signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ® in Asia, focusing on affordable pricing for public health markets in low- and middle-income countries [6][7] - The company also has a prior agreement with Instituto Butantan in Brazil for local vaccine development and distribution [7]
Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ®
Newsfilter· 2025-02-05 06:00
Core Points - Valneva SE has received marketing authorization from the UK for IXCHIQ®, the world's first chikungunya vaccine, which is a single-dose vaccine for individuals aged 18 and older [1][3] - The approval is based on Phase 3 data showing that IXCHIQ® induces a strong immune response that lasts for at least three years [2] - Valneva has received regulatory approvals for IXCHIQ® in the US, Europe, and Canada, and expects approval in Brazil in Q1 2025 [3] Regulatory Approvals - The UK approval is the fourth for IXCHIQ®, which is already approved in the US, Europe, and Canada for adults aged 18 and older [3] - Valneva is pursuing label extension applications to include adolescents aged 12 to 17 in the US, Europe, Canada, and the UK [3] Market Context - The approval comes amid a chikungunya outbreak in India, where 370,000 cases were reported from January 2019 to July 2024, highlighting the need for vaccination among travelers [4] - In 2023, 920,000 UK travelers visited India, making it crucial to provide access to IXCHIQ® for their protection [4] Partnerships and Funding - Valneva has partnered with CEPI to support late-stage development and expand access to IXCHIQ® in low- and middle-income countries (LMICs) [5][6] - CEPI has provided a $41.3 million grant to Valneva to enhance access to the vaccine in LMICs and support post-marketing studies [5][6] Production and Distribution - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ® in Asia at affordable prices for public health markets [6] - The company also has a license agreement with Instituto Butantan in Brazil for local chikungunya vaccine development and distribution [7] Disease Overview - Chikungunya is a mosquito-borne viral disease causing severe joint pain and other symptoms, with significant outbreaks reported globally since 2004 [8][9] - The World Health Organization has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change [9]
Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ®
GlobeNewswire News Room· 2025-02-05 06:00
Core Points - Valneva SE has received marketing authorization from the UK for IXCHIQ®, the world's first chikungunya vaccine, which is a single-dose vaccine for individuals aged 18 and older [1][3] - The approval is based on Phase 3 data showing that IXCHIQ® induces a strong immune response that can last for at least three years [2] - Valneva has received regulatory approvals for IXCHIQ® in the US, Europe, and Canada, and expects approval in Brazil in Q1 2025 [3] Company Developments - The Chief Medical Officer of Valneva emphasized the importance of the vaccine for UK travelers, especially given the current chikungunya outbreak in India, which has seen 370,000 cases reported from January 2019 to July 2024 [4] - Valneva has partnered with CEPI to support late-stage development and expand access to IXCHIQ® in low- and middle-income countries, with a $41.3 million grant from the EU to facilitate this [5][11] - An exclusive license agreement with the Serum Institute of India has been signed to supply the vaccine in Asia at affordable prices [6] Industry Context - Chikungunya is a mosquito-borne viral disease that has been spreading globally since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [9] - The World Health Organization has identified chikungunya as a major public health problem, with the disease's economic impact expected to grow due to climate change [9][10]
Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million
Newsfilter· 2025-01-30 16:45
Core Viewpoint - Valneva SE has signed a new contract worth $32.8 million with the U.S. Department of Defense for the supply of its Japanese encephalitis vaccine, IXIARO® [1][2]. Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases [6]. - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [7]. - Valneva's commercial revenues support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [8]. Product Information - IXIARO® is the only Japanese encephalitis vaccine approved by the U.S. Food and Drug Administration (FDA) and is indicated for active immunization against the disease [3][4]. - The vaccine is approved for individuals aged two months and older in various regions, including the U.S., Europe, and Canada [4]. - Japanese encephalitis is a serious infectious disease primarily found in Asia, with an estimated 70,000 cases occurring annually [5]. Contract Details - The new one-year contract allows the DoD to purchase a minimum of $32.8 million worth of IXIARO® vaccines, with the option for additional doses [2]. - Deliveries under this contract will commence immediately, continuing from a previous supply contract signed in September 2023 [2].
Favorable VLA1553-321 Phase 3 Study Results Boost VALN Stock
ZACKS· 2025-01-21 13:07
Core Insights - Valneva SE reported positive Phase 3 trial data for its chikungunya vaccine IXCHIQ, which is the first licensed vaccine for this virus, addressing a significant unmet medical need [1][2][10] Group 1: Trial Data and Efficacy - The Phase 3 trial VLA1553-321 demonstrated a seroresponse rate of 98.3% one year after a single-dose vaccination in adolescents who were CHIKV negative at baseline, confirming a strong and long-lasting antibody response [4] - The vaccine was generally well tolerated among adolescents, with no safety issues reported by the Independent Data Safety Monitoring Board throughout the trial [5] - The trial involved 754 adolescents and was conducted in Brazil, representing the first clinical trial in an endemic area [6][7] Group 2: Market Impact and Financials - Following the announcement of the trial results, Valneva's share price increased by 1.4% to $4.37, indicating positive market sentiment due to rising chikungunya cases [3] - Valneva has a market capitalization of $346.6 million and is projected to achieve an 8.3% earnings growth in 2024 [3] Group 3: Global Expansion and Regulatory Efforts - Valneva is pursuing marketing authorization for IXCHIQ in Brazil and has submitted applications to the European Medicines Agency and Health Canada, aiming to enhance the vaccine's global reach [8][9] - The Phase 3 trial data may support regulatory approval in Brazil and other Latin American countries, reflecting Valneva's strategic efforts to improve vaccine access in low and middle-income nations [9] Group 4: Public Health Context - The geographical spread of chikungunya, worsened by climate change, highlights the urgent need for accessible vaccines, with over 3.7 million cases reported in the Americas over the past decade [10] - Valneva's advancements with IXCHIQ position the company as a leader in specialty vaccines, contributing to the fight against emerging infectious diseases [11]
Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®
GlobeNewswire News Room· 2024-12-03 06:00
Antibody levels remained high at 96% seroresponse in line with the two-year persistence data This long-lasting antibody persistence was comparable in older (65+) and younger adults Saint-Herblain (France), December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva’s expectations for this vaccine, confi ...
Chikungunya Vaccine Label Extension Call Likely to Support VALN Stock
ZACKS· 2024-11-28 15:31
Valneva SE (VALN) recently applied for a label extension to the FDA to potentially extend the use of its chikungunya vaccine, IXCHIQ. Currently approved for adults, the vaccine may soon be accessible to adolescents aged 12 to 17 years, following the label extension. This submission is backed by positive adolescent Phase 3 data that demonstrated a 99.1% immune response rate and a favorable safety profile in adolescents. Expanding access to this age group addresses a critical gap, particularly as chikungunya ...
Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to the U.S. FDA
GlobeNewswire News Room· 2024-11-26 16:45
To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ®, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody ...
Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2
GlobeNewswire News Room· 2024-11-13 16:45
Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate ...