Welcome to our dedicated page for Valneva Se news (Ticker: VALN), a resource for investors and traders seeking the latest updates and insights on Valneva Se stock.
Valneva SE (VALN) is a French specialty vaccine company whose news flow centers on the development, commercialization and partnering of prophylactic vaccines for infectious diseases with significant unmet medical need. As a biological product manufacturer focused on vaccines, Valneva regularly issues updates on clinical trial progress, regulatory milestones, commercial agreements and financing activities related to its portfolio.
Investors following VALN news can expect frequent coverage of the company’s vaccine pipeline, including its Lyme disease vaccine candidate VLA15, co-developed with Pfizer. Press releases have detailed Phase 2 data, pediatric study results and the initiation of a large Phase 3 study in Lyme disease-endemic regions in Europe and the United States. Company and partner communications also highlight regulatory designations, such as U.S. FDA Fast Track status for VLA15, and planned timelines for potential marketing applications.
Valneva’s news also reflects its broader portfolio and collaborations. Announcements have described the commercialization of vaccines such as IXIARO/JESPECT, DUKORAL and IXCHIQ, as well as licensing and development agreements for new candidates. For example, Valneva licensed a tetravalent Shigella bioconjugate vaccine candidate from LimmaTech Biologics AG and engaged AGC Biologics to supply drug substance for Phase II studies, generating updates on manufacturing partnerships and clinical study launches.
Commercial and distribution partnerships feature prominently in Valneva’s communications. The company has reported agreements to market and distribute VBI Vaccines’ hepatitis B vaccine PreHevbri in selected European countries, illustrating how it uses its commercial infrastructure in Europe. Financing and strategic transactions, including an equity subscription agreement with Pfizer and loan facilities to support development and corporate needs, also appear in its regulatory and press disclosures.
This news page aggregates such announcements, giving readers a single view into Valneva’s clinical, commercial and corporate developments. For those tracking VALN, recurring themes include infectious disease vaccine innovation, co-development with larger pharmaceutical partners, third-party vaccine distribution and updates on regulatory and financing milestones.
AGC Biologics has announced a development and manufacturing agreement with Valneva SE (NASDAQ: VALN) to supply drug substance for a Phase II tetravalent Shigella bioconjugate vaccine candidate at their Heidelberg facility. The partnership aims to establish Phase II supply, building on previous work with LimmaTech Biologics AG.
The vaccine candidate is currently undergoing a Phase 2 infant study and a Phase 2b Human Challenge Study. Shigellosis, causing an estimated 165 million infections worldwide with 62.3 million in children under five, is the second leading cause of fatal diarrheal disease globally.
AGC Biologics' Heidelberg facility offers comprehensive capabilities including cGMP microbial fermentation lines, strain development, and expertise in bacterial and yeast systems.
Valneva and VBI Vaccines have formed a partnership for the marketing and distribution of PreHevbri®, the only 3-antigen hepatitis B vaccine approved in Europe. Valneva will distribute the vaccine in select European markets, including the UK, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands, with availability expected in early 2023. This collaboration signifies Valneva's commitment to vaccine commercialization and aims to enhance access to this critical vaccine, which targets over 290 million globally infected with hepatitis B.
Pfizer (PFE) and Valneva (VALN) have initiated a Phase 3 clinical study named VALOR to evaluate their investigational Lyme disease vaccine, VLA15, among 6,000 participants in Lyme-endemic areas in Europe and the U.S. This randomized, placebo-controlled trial aims to investigate the vaccine's efficacy, safety, and immunogenicity. VLA15 is the only Lyme vaccine candidate currently in clinical development, and prior studies have shown promising immunogenicity and tolerability. Pfizer plans to submit regulatory applications by 2025, upon successful trial completion.
Pfizer has announced a €90.5 million ($95 million) investment in Valneva, acquiring an 8.1% stake in the company. This investment is aimed at supporting the development of VLA15, a Lyme disease vaccine candidate, with the Phase 3 study set to begin in Q3 2022. Pfizer will also update the collaboration agreement with Valneva, increasing Valneva's contribution to 40% of shared development costs. The total potential milestone payments to Valneva remain at $168 million, with royalties adjusted to a tiered range of 14% to 22%.
Valneva SE and Pfizer reported positive Phase 2 results for their Lyme disease vaccine candidate, VLA15, showing a strong immunogenic response in participants aged 5-17. One month post-vaccination, pediatric participants demonstrated better immunogenicity compared to adults. The safety profile was consistent with earlier adult trials, with no serious adverse events noted. Both companies plan to include pediatric participants in the upcoming Phase 3 trial, set to begin in Q3 2022, pending regulatory approval.
ShouTi Inc., a clinical-stage biopharmaceutical company, has appointed Sharon Tetlow to its board of directors, where she will also chair the audit committee. With over 30 years of experience in life sciences finance, Tetlow has previously held senior roles including CFO at various biopharmaceutical firms. She currently serves on the boards of Dice Therapeutics (DICE), Valneva SE (VALN), and Catalyst Biosciences (CBIO). Her expertise is expected to strengthen ShouTi's growth strategy as the company focuses on developing innovative oral therapeutics for chronic diseases.
Pfizer reported full-year 2021 revenues of $81.3 billion, marking a 92% operational growth, with fourth-quarter revenues at $23.8 billion, reflecting a 106% increase. Excluding COVID-19 vaccine Comirnaty and treatment Paxlovid, operational revenue growth was 6% for the year, but declined by 2% in Q4. The adjusted diluted EPS for 2021 was $4.42, and Pfizer issued 2022 guidance expecting revenues between $98 billion and $102 billion, alongside adjusted diluted EPS of $6.35 to $6.55. The guidance includes anticipated revenues of $32 billion from Comirnaty and $22 billion from Paxlovid.
Pfizer reported third-quarter 2021 revenues of $24.1 billion, a 134% increase year-over-year, driven by the success of the Comirnaty vaccine, which contributed $13 billion. Excluding Comirnaty, revenues still grew 7% to $11.1 billion. The reported diluted EPS was $1.42, with adjusted EPS at $1.34. Pfizer raised its full-year revenue guidance to $81-82 billion and adjusted EPS to $4.13-4.18. The company anticipates around $36 billion in revenue from Comirnaty for 2021, with plans to deliver 2.3 billion doses globally.