Chikungunya

Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates

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火曜日, 5月 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.

Grifols Procleix ArboPlex Assay® Receives CE Mark, the First and Only 4-in-1 NAT for Arbovirus Screening

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木曜日, 4月 4, 2024
Certification, Plasma, CE, GRFS, Risk, Arbovirus, Climate, RNA, GRF, Fever Dream, IVDR, Chikungunya, Death, Dengue virus, MCE, Blood bank, NAT, Vertically transmitted infection, Medical device

These are the four most significant arboviruses of concern, all spread through mosquito vectors.

Key Points: 
  • These are the four most significant arboviruses of concern, all spread through mosquito vectors.
  • With the dengue virus alone, there were more than 5 million cases and 5,000 deaths reported globally in 2023.1
    Further strengthening the Grifols Procleix portfolio for blood donor screening, the Procleix ArboPlex Assay uses plasma or serum samples to detect arboviral RNA.
  • Blood banks and collection centers could decide that deferrals are unnecessary if donors were tested and found negative using the Procleix ArboPlex Assay.
  • “With its 4-in-1 arbovirus test feature, the Grifols Procleix ArboPlex Assay has the ability to speed up and overall improve donor screening laboratory efficiency,” said Antonio Martínez, president of Grifols Diagnostic Business Unit.

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

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火曜日, 3月 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 to Present on its Chikungunya Vaccine IXCHIQ®, Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C.

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木曜日, 3月 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 to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences

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月曜日, 3月 4, 2024
Pfizer, ACIP, Indoor Living, Conference, VLA, CHMP, Saint-Herblain, Chikungunya, Euronext Paris

Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe.

Key Points: 
  • Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe.
  • CEO Thomas Lingelbach will present Valneva at the TD Cowen 44th Annual Health Care Conference, taking place March 4 - 6, 2024, in Boston, MA.
  • Mr. Lingelbach and CFO Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences Conference, held April 16 - 17, 2024, in Amsterdam, The Netherlands.
  • VLA15, the Company’s Lyme disease vaccine candidate, is currently in Phase 3 clinical development and partnered with Pfizer for this study and global commercialization.

U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ®

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木曜日, 2月 29, 2024
ACIP, Person, MD, FDA, Food, Risk, VLA, Vaccination, MMWR, Food and Drug Administration, Family, Saint-Herblain, Disease, CDC, Chikungunya, Ageing, Euronext Paris, Vaccine

ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak.

Key Points: 
  • ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak.
  • ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV.
  • IXCHIQ offers advantages to travelers on vacation and visiting family and to people engaged in business ventures, missions, or laboratory duties.
  • We embrace the ACIP endorsement, marking IXCHIQ® as the only approved and recommended vaccine for the target population.

Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency

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金曜日, 2月 23, 2024
Marketing, EMA, Marketing Authorisation Application, Committee, MAA, Food, BLA, Nature, Vaccination, CHMP, European Medicines Agency, Public, Chikungunya, OMX, Ageing, CHIKV, Vaccine

Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.

Key Points: 
  • Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.
  • COPENHAGEN, Denmark, February 23, 2024 – Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP, the Company’s investigational chikungunya vaccine.
  • Bavarian Nordic is on track and plans to submit its MAA for CHIKV VLP to the EMA during H1 2024.
  • “We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market.

Co-Diagnostics, Inc. JV CoSara Receives Clearance from Indian Regulators for Influenza Multiplex PCR Test

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木曜日, 3月 7, 2024
Influenza, Hepatitis B, CDSCO, FDA, Point-of-care testing, Growth, 2005 in television, Sale, ABC, Euro starter kits, Malaria, COVID-19, Fever Dream, RT, Mycobacterium tuberculosis, HPV, Chikungunya, PCR, Hepatitis C, IVD, Vaccine

SALT LAKE CITY, March 7, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its SARAPLEX™ Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic ("IVD") for the detection and differentiation of Influenza A and Influenza B.

Key Points: 
  • Co-Primers utilize a unique design architecture to combat common issues with real-time PCR that can lead to inaccurate results, specifically primer dimer propagation, and which are magnified in multiplex reactions.
  • "The importance of accurate, reliable PCR testing at the high-throughput clinical laboratory level remains critical," remarked Dwight Egan, CEO of Co-Diagnostics.
  • *The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
  • The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.

Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance

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木曜日, 2月 15, 2024
Total, Bavarian Nordic, Investment, Cash, Growth, Sale, Government, VLA, COVID-19, COVID, Third party, PRV, Chikungunya, Bank statement, Euronext Paris, Travel, OrbiMed

The Company will publish its 2023 audited consolidated financial statements on March 20, 2024.

Key Points: 
  • The Company will publish its 2023 audited consolidated financial statements on March 20, 2024.
  • Peter Bühler, Valneva’s Chief Financial Officer, commented, “In 2023, Valneva successfully executed on key strategic objectives despite a difficult economic environment.
  • Total revenues in 2022 included €280.0 million of revenue recognition mainly related to the COVID-19 supply agreements in the prior year.
  • Other income is anticipated between €95 million and €105 million, including the PRV sold in early 2024 for €95 million.

Valneva Announces Sale of Priority Review Voucher for $103 Million

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月曜日, 2月 5, 2024
VLA, PRV, Chikungunya, FDA, Euronext Paris, Saint-Herblain, Food, Disease, Vaccine, Risk, Lyme disease, Sale, Priority review, U.S. FDA, Pharmaceutical industry

Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million).

Key Points: 
  • Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million).
  • With this approval, IXCHIQ® became the world’s first licensed chikungunya vaccine available to address this unmet medical need.
  • As shown with the recent approval of our chikungunya vaccine, we remain committed to growing our portfolio of vaccines addressing unmet medical needs which have the potential to transform people’s lives.”
    Under the tropical Disease Priority Review Voucher Program, FDA awards priority review vouchers to sponsors of tropical disease product applications that meet certain criteria.
  • PRVs can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.