Valneva Se - VALN STOCK NEWS

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.