6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

H.C. Wainwright initiated coverage of Valneva SE with a rating of Buy and set a new price target of $34.00

Saint-Herblain (France), June 26, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2023 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment of a new director to its Board. Ms. Danièle Guyot-Caparros was appointed to Valneva's Board of Directors for a three-year term. Ms. Guyot-Caparros has a proven track record in finance and business

Saint-Herblain (France), May 21, 2024 – Valneva SE (NASDAQ:VALN, 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. Dr. Schuitemaker brings more than two decades of experience in vacc

Saint-Herblain (France), June 21, 2023 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2022 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, as well as the appointment of a new Supervisory Board member and the reappointment of two of them. Dr Kathrin U Jansen, Ph.D., a German national with over 30 years of vaccine R&D experience, was appointed to Valneva's Supervisory

Saint-Herblain (France), November 17, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the appointment of Dipal Patel as Chief Commercial Officer (CCO) and Management Board member. With this newly created role, Valneva strengthens its management team with a recognized commercial industry leader as the Company advances its chikungunya vaccine candidate towards potential market entry in 2023. Ms. Patel is an established commercial leader with over 23 years of experience in the pharmaceutical sector covering commercial strategy, execution, market access and lifecycle management. Over her career, she has held roles of increasing responsibilities across mu

Saint-Herblain (France), June 24, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held yesterday in Paris. Among the adopted resolutions were approval of the 2021 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment, for a three-year term, of two new Supervisory Board members. Bpifrance Participations was appointed to Valneva's Supervisor Board and will be represented by Maïlys Ferrère. Ms. Ferrère, a French national, is

Saint-Herblain (France), May 31, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, announced today the appointment of leading vaccine experts Dr. Thomas Decker and Dr. Michael Pfleiderer to its Scientific Advisory Board (SAB). Dr. Thomas Decker is a professor of Immunobiology at the Max Perutz Labs of the University of Vienna. His experience as an immunobiologist stems from more than 30 years of research and teaching in Germany, Sweden, Austria and the USA, with a focus on the molecular aspects of immunity to infection. During his career, Dr. Decker also served as a consultant for several pharmaceutical companies. He was Chair of the Department of Microbiology and Gen

ShouTi Inc., a clinical-stage global biopharmaceutical company developing novel oral therapeutics to treat a wide range of chronic diseases, today announced the appointment of Sharon Tetlow to the company's board of directors. Ms. Tetlow will also serve as chair of the audit committee. "On behalf of the board and management team at ShouTi, I am pleased to welcome Sharon to the board," said Daniel Welch, Chairman of the Board, ShouTi. "Sharon is an accomplished life sciences finance executive whose deep financial strategy and compliance expertise will be instrumental in leading our audit committee. With an outstanding track record of advising biopharmaceutical companies, Sharon's perspectiv

Ratings for Valneva (NASDAQ:VALN) were provided by 8 analysts in the past three months, showcasing a mix of bullish and bearish perspectives. The table below offers a condensed view of their recent ratings, showcasing the changing sentiments over the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 8 0 0 0 0 Last 30D 1 0 0 0 0 1M Ago 2 0 0 0 0 2M Ago 3 0 0 0 0 3M Ago 2 0 0 0 0 Analysts have recently evaluated Valneva and provided 12-month price targets. The average target is $26.0, accompanied by a high estimate of $26.00 and a low estimate of $26.00. Staying constant with the previous ave

HC Wainwright & Co. analyst Edward White reiterates Valneva (NASDAQ:VALN) with a Buy and maintains $26 price target.

Valneva to receive up to $41.3 million from CEPI and the European Union to expand access to chikungunya vaccine, IXCHIQ® Funding will support clinical trials in vulnerable groups, such as children and pregnant women Partnership will also support technology transfer to an additional manufacturer to supply IXCHIQ® to Asian LMICs IXCHIQ® is already approved for use in adults 18 years of age and older in the U.S., Canada and Europe

On Wednesday, Pfizer Inc (NYSE:PFE) and Valneva SE (NASDAQ:VALN) announced that the participants of the Phase 3 VALOR trial have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15. Lyme disease is a bacterial infection that can be spread to humans by infected ticks. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025. "VLA15, the Lyme disease vaccine candidate we are co-developing with Valneva, is the one which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress," said Annaliesa Anderson, Ph.D., Senior Vice President and

Participants completed primary vaccination series (3 doses) with VLA15 Primary vaccination series to be followed by a booster approximately one year after completionNew York, NY and Saint-Herblain (France), July 17, 2024 – Pfizer Inc. (NYSE:PFE) and Valneva SE (NASDAQ:VALN, PARIS:VLA) today announced that the participants of the Phase 3 trial "Vaccine Against Lyme for Outdoor Recreationists" (VALOR) have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.1,

HC Wainwright & Co. analyst Edward White reiterates Valneva (NASDAQ:VALN) with a Buy and maintains $26 price target.

Throughout the last three months, 6 analysts have evaluated Valneva (NASDAQ:VALN), offering a diverse set of opinions from bullish to bearish. The following table summarizes their recent ratings, shedding light on the changing sentiments within the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 6 0 0 0 0 Last 30D 1 0 0 0 0 1M Ago 2 0 0 0 0 2M Ago 3 0 0 0 0 3M Ago 0 0 0 0 0 The 12-month price targets assessed by analysts reveal further insights, featuring an average target of $26.0, a high estimate of $26.00, and a low estimate of $26.00. This current average is unchanged from the previou

HC Wainwright & Co. analyst Edward White reiterates Valneva (NASDAQ:VALN) with a Buy and maintains $26 price target.

 Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidan

 First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasingNet Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million  Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarterSignificantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial

Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates Q1 financial highlights Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated full year guidance Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV)1. Significantly extended cash runway with recent update of debt financing agreement2Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter Net Profit of €58.9 million, reflecting PRV sale 2024 financial guidance confirmed Expected tot

 Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26%Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million from sale of Priority Review Voucher (PRV)1    Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway2Operational business considered sufficiently funded (excluding debt repayment) until commercial revenues from Lyme program enable sustained profitability Excellent progress across R&D pipeline          Appr

Product sales of €106.1 million, an increase of 42.6% compared to the first nine months of 2022 IXIARO® and DUKORAL® sales benefited from a continued recovery of the travel industryTotal revenues of €111.8 million in the first nine months of 2023 Cash position of €171.3 million as of September 30, 2023 Includes $50 million of the $100 million available following upsize of credit facility with leading U.S. Healthcare Funds Deerfield and OrbiMed in August 20231Includes a significant payment made to Pfizer in the third quarter of 2023 related to the companies' Phase 3 Lyme disease study "VALOR" Chikungunya: progressing towards potential licensure of the world's first chikungunya vacci

 Product sales more than doubled in the first half of 2023 to €69.7 million compared to €33.3 million in the first half of 2022 Driven by IXIARO® and DUKORAL® sales, both of which benefited from a continued recovery of the travel industry as well as from price increasesBringing total revenues to €73.7 million in the first half of 2023 Strong cash position of €204.4 million as at June 30, 2023 Excludes up to an additional $100 million made available as part of a recent upsized financing arrangement with leading U.S. Healthcare Funds Deerfield and OrbiMed1 Chikungunya: progressing towards delivery of the world's first chikungunya vaccine Biologic License Application (BLA) current

Saint-Herblain (France), August 31, 2023 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023. The Company will discuss its single-dose vaccine candidate against the chikungunya virus (VLA1553), currently under priority review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) action date planned for end of November 20231, as well as its Lyme disease vaccine candidate (VLA15), which is currently in Phase 3 clinical trials led by Valneva's development partner Pfizer. The Comp

Product sales increased 98.6% to €32.1 million in the first quarter of 2023 compared to €16.2 million in the first quarter of 2022 Driven by IXIARO® and DUKORAL® sales both of which more than quadrupled year-over-yearTotal revenues of €33.5 million in the first quarter of 2023 compared to €21.8 million in the first quarter of 2022 Strong cash position of €254.5 million at March 31, 2023 Chikungunya: progressing towards delivery of the world's first chikungunya vaccine Prescription Drug User Fee Act (PDUFA) review goal date confirmed for end of August 2023 by the U.S. Food and Drug Administration (FDA) Additional regulatory submission process to be initiated in the second quarter of 2023

Excellent progress on clinical programs Lyme Disease Vaccine Candidate VLA15 Further positive Phase 2 results reported, including first pediatric data Phase 3 expected to commence in the third quarter of 2022 Inactivated COVID-19 Vaccine Candidate VLA2001 Conditional Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK)Emergency use authorization granted by the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain and first vaccinations confirmed Rolling review ongoing with the European Medicines Agency (EMA); Valneva has provided responses to the latest list of questions (LOQ) Single-Shot Chiku