VLA

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

Retrieved on: 
Thursday, February 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

Retrieved on: 
Monday, February 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.

Lead Acid Battery Market in US to record a growth of USD 1.17 billion between 2022 to 2027; C and D Technologies Inc., and Camel Group Co. Ltd to emerge as key vendors- Technavio

Retrieved on: 
Tuesday, January 23, 2024
BCI, EVS, Aviation, Lighting, EPA, Energizer, Exide, Car, ICE, VRLA, EnerSys, UPS, VLA, AGM, Gel, Battery Council International, GS Yuasa, Safety, USD, Johnson Controls, Telecommunications, Lithium battery, Teledyne Technologies, Electric battery

NEW YORK, Jan. 22, 2024 /PRNewswire/ -- The lead acid battery market in US size is expected to grow by USD 1.17 billion from 2022 to 2027, according to Technavio.

Key Points: 
  • NEW YORK, Jan. 22, 2024 /PRNewswire/ -- The lead acid battery market in US size is expected to grow by USD 1.17 billion from 2022 to 2027, according to Technavio.
  • The US Lead Acid Battery Market sees substantial growth in the mobile segment, encompassing batteries for cars, internal combustion engine (ICE) vehicles, electric vehicles (EVs), commercial vehicles, and two-wheelers.
  • Imperative Insights on the following aspects:
    What was the size of the global lead acid battery market by value?
  • The train battery market is estimated to grow at a CAGR of 5.45% between 2022 and 2027.

Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine

Retrieved on: 
Wednesday, January 10, 2024
Ageing, European Medicines Agency, Saint-Herblain, VLA, Chikungunya, Risk, Euronext Paris, Food, Immunogenicity, Safety, FDA, Health Canada

Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine.

Key Points: 
  • Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine.
  • There is currently no approved chikungunya vaccine for children and Valneva’s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine2 to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus.
  • Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This pediatric trial is extremely important.
  • Given the significant threat that chikungunya poses to individuals living in or traveling to endemic areas, it is crucial to make the vaccine accessible to all age groups.

Funnel Releases 2023 Highlights

Retrieved on: 
Thursday, January 11, 2024
Specialization, Zillow, National Apartment Association, Life, Partnership, Housing, CRE, PINK, VLA, Woman, Organization, NAA, CRM, System, Integrity, Automation, ID, HOME, Plaid, Commercial property

TAMPA, Fla., Jan. 11, 2024 /PRNewswire/ -- Funnel Leasing, the only front office product suite to successfully centralize operations for leading companies, today announced its 2023 highlights. Throughout the past year, Funnel continued to innovate and disrupt the multifamily industry through partnerships with its clients and expanding the company's suite of products. From continued iteration of their products, to HOME by Funnel Inc. making its first donation to a charity partner organization, to earning awards, to closing on a new round of funding it was an outstanding year for Funnel.

Key Points: 
  • QuadReal leads the Canadian market with the first adoption of Funnel to drive centralized leasing portfolio-wide.
  • Non-profit, HOME by Funnel Inc., made its first donation to partner organization: Entryway
    The inaugural partnership between the two non-profits brings to life HOME by Funnel Inc.'s goal of creating housing equality.
  • The work knows no end, HOME plans to raise money to support housing equity from various sources, including Funnel Leasing, Inc., which will donate $1 from every new lease signed using Funnel Leasing's online leasing solution.
  • Funnel was honored with multiple additional multifamily and real estate Influencer awards:
    Our CRO, Johnny Hanna, former Entrata and Homie co-founder , was recognized as a 2023 Multifamily Influencer by GlobeSt.

Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum

Retrieved on: 
Thursday, January 4, 2024
Conference, Euronext Paris, Saint-Herblain, CFO, FDA, Disease, ODDO BHF, Chikungunya, VLA

Saint-Herblain (France), January 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8 – 10, 2024 in San Francisco and virtually at the Oddo BHF Forum on January 15,2024.

Key Points: 
  • Saint-Herblain (France), January 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8 – 10, 2024 in San Francisco and virtually at the Oddo BHF Forum on January 15,2024.
  • Valneva’s CEO and CFO will notably discuss the Company’s advanced vaccine development pipeline, including its Lyme disease vaccine candidate VLA15 (Phase 3 fully enrolled, partnered with Pfizer), as well as the Company’s growing commercial business, which now includes recently FDA-approved1 IXCHIQ®, the world’s first licensed vaccine for prevention of disease caused by chikungunya virus, launching in early 2024.
  • To schedule a 1on1 investor meeting with Valneva, institutional investors and analysts can

Valneva Provides Updated 2023 Financial Guidance

Retrieved on: 
Friday, December 29, 2023
Risk, U.S. FDA, Euronext Paris, Sale, Saint-Herblain, FDA, Disease, PRV, COVID-19, Chikungunya, VLA

Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023.

Key Points: 
  • Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023.
  • Product sales guidance remains unchanged, as do anticipated R&D expenses.
  • The Company’s previous guidance included expected total revenues and other income between €220 million and €260 million1.
  • Peter Bühler, Chief Financial Officer of Valneva, said, “We remain confident in our ability to sell our priority review voucher successfully at a price within the previously suggested range.

Valneva Shareholders Approve EGM Resolutions Including the Transition to a Board of Directors

Retrieved on: 
Wednesday, December 20, 2023
MSD, Sanofi Pasteur, Trust, EGM, Euronext Paris, Saint-Herblain, Executive Committee, Annual general meeting, Supervision, General counsel, Management, Supervisory board, VLA

These included the immediate transition from the Company’s two-tier governance model to a one-tier model led by a Board of Directors.

Key Points: 
  • These included the immediate transition from the Company’s two-tier governance model to a one-tier model led by a Board of Directors.
  • During a constitutional post-EGM meeting, Valneva’s former Supervisory Board member Anne-Marie Graffin was elected as Chair of the Company’s new Board of Directors.
  • Ms. Graffin is Vice Chair of Nanobiotix’s Supervisory Board, member of the Sartorius Stedim Biotech Board of Directors and member of Vetoquinol S.A Board of Directors.
  • Anne-Marie Graffin, Chair of Valneva´s Board of Directors, commented, “I would like to thank all departing Supervisory Board members for their contributions and the newly elected Board of Directors members for their trust.

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Retrieved on: 
Monday, December 4, 2023
DSMB, Food, Șaeș, Euronext Paris, BLA, Data monitoring committee, Marketing, PFE, FDA, EMA, MAA, Lyme disease, Disease, Research, Biologics license application, European Medicines Agency, VLA, Safety, Development, Senior, Vaccine

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Key Points: 
  • Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15
    9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic
    Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026
    New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15.
  • The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
  • “We are pleased that the Phase 3 trial recruitment is complete.
  • Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4

Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®

Retrieved on: 
Monday, December 4, 2023
Interest group, Licensure, Șaeș, U.S. FDA, Euronext Paris, Antibody, EMA, FDA, Ageing, Trial of the century, Vaccination, Public, Health Canada, Chikungunya, VLA, Safety, Vaccine

These persistence data are intended to supplement the existing approval by U.S. FDA and ongoing regulatory approval processes.

Key Points: 
  • These persistence data are intended to supplement the existing approval by U.S. FDA and ongoing regulatory approval processes.
  • 97% of the 316 healthy adults still enrolled in the trial retained neutralizing antibody titers above the seroresponse threshold2 twenty-four months after the single-dose vaccination.
  • Being the world's first approved vaccine against chikungunya, each positive outcome further strengthens the defense against this significant and expanding public health threat.”
    Valneva was granted U.S. FDA approval4 for its chikungunya vaccine IXCHIQ® in November 20235.
  • A clinical study in adolescents is also ongoing in Brazil for which the Company reported positive pivotal Phase 3 data in November 20236.