VLA

Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine

Retrieved on: 
Freitag, Mai 31, 2024
Partnership, Aedes, Health care, Licensure, ANVISA, Marketing, Coalition, CHMP, Food, European Medicines Agency, VLA, FDA, Ageing, Disease, Iberian languages, Climate change, Vaccine, IRP, Fever Dream, Instituto Butantan, European Commission, EMA, Epidemic, Vaccination, MHRA, CEPI, MAA, Health Canada, Committee, Virus, European, Euronext Paris, Brazilian Health Regulatory Agency

If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need.

Key Points: 
  • If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need.
  • In accordance with the International Recognition Procedure (IRP)1, Valneva is also preparing a Marketing Authorization Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
  • The CHMP opinion follows the November 2023 approval of IXCHIQ® by the US Food and Drug Administration (FDA)2.
  • Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This positive CHMP opinion marks a crucial milestone toward introducing a preventative solution against chikungunya in the EU.

Valneva Appoints Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer

Retrieved on: 
Dienstag, Mai 21, 2024
Infection, Executive Committee, COVID-19, Translational medicine, HIV, J&J, VLA, Johnson & Johnson, RSV, Vaccine, Research, Chikungunya, CSO, Saint-Herblain, Lyme disease, Viral disease, Euronext Paris, Senior

Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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.

Key Points: 
  • Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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.
  • She has a unique and solid scientific background, which is notably reflected in more than 350 scientific publications.

Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates

Retrieved on: 
Dienstag, Mai 7, 2024
FDA, VLA, Bank statement, Fast Track, Research, CHMP, Trial of the century, Biologics license application, Coalition, Profit & Loss, OrbiMed, Lyme disease, Bavarian Nordic, CDC, Notifiable disease, Adolescence, Income tax, Chikungunya, Third party, ACIP, BLA, Licensure, CEPI, PRV, Safety, Travel, Indoor Living, EMA, Marketing, USD, Sale, Tropical disease, EDT, Depreciation, MAA, Profit, Euronext Paris, Zika virus, Epidemic, Adjustment, COGS, Saint-Herblain, COVID-19, Growth, Ageing

Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates.

Key Points: 
  • Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates.
  • The condensed consolidated interim financial results are available on the Company’s website ( Financial Reports – Valneva ).
  • In the first quarter of 2024, IXIARO®/JESPECT® sales were €16.6 million compared to €17.4 million in the first quarter of 2023.
  • IXIARO®/JESPECT® sales were €16.6 million in the first quarter of 2024 compared to €17.4 million in the first quarter of 2023.

EPS Learning Programs Selected by Virginia Board of Education as Recommended Literacy Solutions

Retrieved on: 
Montag, April 15, 2024
Family, VLA, Learning, Vocabulary, Risk, SPIRE, Education, Comprehension, School, Literacy, SOL, Curriculum, Legislation, EPS, Recipe, Student, Tutoring

BETHESDA, Md., April 15, 2024 /PRNewswire-PRWeb/ -- EPS Learning, the leading provider of PreK-12 literacy solutions, announced that four of its programs have been recommended by the Virginia Board of Education for evidence-based literacy instruction that's aligned to science-based reading research. The recognition supports Virginia schools in a multi-year effort to improve early learning outcomes for students who are below proficiency levels in reading.

Key Points: 
  • BETHESDA, Md., April 15, 2024 /PRNewswire-PRWeb/ -- EPS Learning , the leading provider of PreK-12 literacy solutions, announced that four of its programs have been recommended by the Virginia Board of Education for evidence-based literacy instruction that's aligned to science-based reading research.
  • "We champion Virginia's significant efforts to ensure that all students in the state can access literacy as the springboard to lifelong learning and opportunity."
  • To remedy reading proficiency beginning in the 2024–2025 school year, the Virginia Literacy Act (VLA) will mandate core literacy and research-grounded instruction for K–5 students.
  • EPS Learning programs meet the required parameters to be recommended as top literacy intervention solutions, including alignment with evidence-based literacy instruction, comprehensive and intensive intervention, support that is accessible and can be easily implemented into any curriculum, inclusivity and representation.

Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate

Retrieved on: 
Dienstag, März 26, 2024
Notifiable disease, Saint-Herblain, Zika virus, JE, COVID-19, VLA2001, Ageing, Public, Chikungunya, Woman, Mosquito-borne disease, VLA, Safety, Euronext Paris, Access, CpG, Food, Vaccine

Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the

Key Points: 
  • Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the
    the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV).
  • The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States.
  • Phase 1 results from Valneva’s first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested doses and schedules2.
  • This preference stems from the understanding that the primary recipients of a Zika vaccine are anticipated to be women of childbearing age, potentially including those who are pregnant.

Valneva Announces Filing of 2023 Universal Registration Document and US Form 20-F

Retrieved on: 
Montag, März 25, 2024
Saint-Herblain, URD, VLA, Euronext Paris, File, AMF, Cryptocurrency

Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).

Key Points: 
  • Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).
  • Valneva’s 2023 Universal Registration Document – available in its entirety in French – includes the Company’s 2023 Annual Financial Report, the Company's Annual Management Report, the Board of Directors’ Corporate Governance Report and the Company’s Sustainability Report.
  • These documents are available on Valneva’s website ( https://valneva.com/investors/financial-reports/ ) and will also be available on the AMF ( www.amf-france.org/ ) and SEC ( www.sec.gov/ ) websites, respectively.
  • Hard copies of these documents may be obtained from the Company, free of charge, upon request at the following address: 6 rue Alain Bombard, 44800 Saint-Herblain, France.

Valneva to Present on its Chikungunya Vaccine IXCHIQ®, Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C.

Retrieved on: 
Donnerstag, März 21, 2024
Control, EST, Congress, Lyme disease, CEPI, Coalition, Saint-Herblain, Pan American Health Organization, Walter, PAHO, International Vaccine Institute, Chikungunya, Epidemic, Drug, IVI, CDC, Process, VLA, Euronext Paris, Market access, ACIP, The 24th

The Company will have a display in the exhibit area of the congress at booth #433.

Key Points: 
  • The Company will have a display in the exhibit area of the congress at booth #433.
  • There will be two sessions, from 11:40 to 12:20 EST and again from 12:30 to 1:10pm EST.
  • Advisory Committee on Immunization Practices (ACIP)1 and these recommendations were adopted by the Centers for Disease Control and Prevention (CDC)2.
  • Additionally, Valneva CEO Thomas Lingelbach will present the Best Production / Process Development award at the event.

Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed

Retrieved on: 
Montag, März 18, 2024
Euronext Paris, OrbiMed, Saint-Herblain, VLA, Airline

Reimbursements of the first $100 million tranche will now start in January 2026 instead of July 2024.

Key Points: 
  • Reimbursements of the first $100 million tranche will now start in January 2026 instead of July 2024.
  • Maturity of this first tranche will remain in the first quarter of 2027.
  • Peter Bühler, Chief Financial Officer of Valneva, said, “We greatly appreciate the continued support from Deerfield and OrbiMed.
  • Valneva announced amendments to the terms in January 20212 and upsizing in April 20223 and August 20234.

Aircraft Engine Test Cells Market worth $4.1 billion by 2028 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Donnerstag, März 14, 2024
Aircraft, Compressor, Component, Growth, Projection, CEL, APU, WBA, Original equipment manufacturer, Noise, Business, Air travel, General aviation, UAV, MRO, Sale, Aviation, Acquisition, Software, Commercial, Commercial aviation, Calspan, Fixed, Life, SAF, OEM, Auxiliary power unit, Investment, VLA, Advanced Air Mobility, NBA, AAM, Rotorcraft, Gear, Hybrid electric vehicle, Airline

The market for aircraft engine test cell solutions has been divided into four segments based on engine tests: piston engine, APU, turbofan, turbojet, and turboshaft (Auxiliary Power Unit).

Key Points: 
  • The market for aircraft engine test cell solutions has been divided into four segments based on engine tests: piston engine, APU, turbofan, turbojet, and turboshaft (Auxiliary Power Unit).
  • Due to its superior altitude capability over other engine types, turbofans are expected to dominate the aircraft engine test cells market throughout the forecast period.
  • Based on solution type, the test cells segment is projected to lead the aircraft engine test cells industry during the forecast period.
  • The market for aircraft engine test cell solutions has been divided into test cell, component test bench, software, ancillary system, and data acquisition & control system.

Aircraft Engine Test Cells Market worth $4.1 billion by 2028 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Donnerstag, März 14, 2024
Aircraft, Compressor, Component, Growth, Projection, CEL, APU, WBA, Original equipment manufacturer, Noise, Business, Air travel, General aviation, UAV, MRO, Sale, Aviation, Acquisition, Software, Commercial, Commercial aviation, Calspan, Fixed, Life, SAF, OEM, Auxiliary power unit, Investment, VLA, Advanced Air Mobility, NBA, AAM, Rotorcraft, Gear, Hybrid electric vehicle, Airline

The market for aircraft engine test cell solutions has been divided into four segments based on engine tests: piston engine, APU, turbofan, turbojet, and turboshaft (Auxiliary Power Unit).

Key Points: 
  • The market for aircraft engine test cell solutions has been divided into four segments based on engine tests: piston engine, APU, turbofan, turbojet, and turboshaft (Auxiliary Power Unit).
  • Due to its superior altitude capability over other engine types, turbofans are expected to dominate the aircraft engine test cells market throughout the forecast period.
  • Based on solution type, the test cells segment is projected to lead the aircraft engine test cells industry during the forecast period.
  • The market for aircraft engine test cell solutions has been divided into test cell, component test bench, software, ancillary system, and data acquisition & control system.