NEW YORK, March 24, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Valneva and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On March 23, 2026, Va ...

Key Takeaways VALN stock dropped 37% after its Lyme vaccine missed a key statistical benchmark in a phase III study.Valneva reported 73.2% efficacy at 28 days, but the confidence interval fell below the required threshold.PF-07307405 showed 74.8% efficacy in a second analysis, supporting planned global filings.Shares of Valneva (VALN) tanked 37% on Monday after the company reported top-line results from the phase III VALOR study, which evaluated its experimental Lyme disease vaccine, PF-07307405 (formerly V ...

The Phase 3 VALOR trial results showed that fewer Lyme disease cases were accrued than anticipated, and the primary endpoint was not met in the first analysis.Secondary Analysis For Valneva DrugHowever, the second analysis indicated clinically meaningful efficacy, with Pfizer expressing confidence in the vaccine’s potential and planning submissions to regulatory authorities.In the pre-specified analyses:Efficacy of 73.2% from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease case ...

Share Resize Pfizer and its partner plan to seek regulatory approval for a Lyme disease vaccine. Photo: Arun Sankar/Agence France-Presse/Getty Images Pfizer and French partner to seek approval for Lyme disease vaccine after late-stage trial - MarketWatch Pfizer and French partner to seek approval for Lyme disease vaccine after late-stage trial Valneva shares slump as the primary endpoint didn't meet statistical significance Published: March 23, 2026 at 7:07 a.m. ET About the Author Steve Goldstein Steven Go ...

Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial Mar 23, 2026 6:45 AM Eastern Daylight Time Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial Share NEW YORK & LYON, France--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced topline results from the Phase 3 VALOR "Vaccine Against Lyme for Outdoor Recreationists†clinical trial (NCT0 ...

Chief Financial Officer Peter Bühler reported total product sales of EUR 157.9 million , in line with guidance, down 3.3% year over year (down 1.3% at constant currency). He attributed the decline primarily to a planned reduction in third-party product sales and, to a lesser extent, adverse currency impacts. Bühler said proprietary product sales, excluding currency effects, grew 9% year over year.Chief Executive Officer Thomas Lingelbach said total revenues exceeded EUR 170 million in 2025, slightly above 2 ...

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Valneva (NasdaqGS:VALN) Q4 2025 Earnings call March 18, 2026 10:00 AM ET Company ParticipantsJoshua Drumm - VP of Global Investor RelationsPeter Bühler - CFOThomas Lingelbach - CEOConference Call ParticipantsAmi Fadia - AnalystBrandon Folkes - AnalystDamien Choplain - AnalystMaury Raycroft - AnalystRajan Sharma - AnalystSimon Scholes - AnalystNone - AnalystOperatorGood day, and thank you for standing by. Welcome to Valneva's full year 2025 results and business update conference call and webcast. At this tim ...

Financial Data and Key Metrics Changes - Total revenues for Valneva exceeded EUR 170 million, slightly above 2024 levels, with nearly EUR 160 million in product sales [4] - Operating loss reached EUR 82.1 million compared to an operating profit of EUR 13.3 million in 2024, primarily due to non-recurring income from the sale of a priority review voucher in the previous year [20] - The company reported a loss for the period of EUR 115.2 million, with adjusted EBITDA at -EUR 51.4 million [20] Business Line Data and Key Metrics Changes - Total product sales reached EUR 157.9 million, decreasing by 3.3% over 2024, primarily due to planned reductions in third-party sales [15] - IXIARO sales grew to EUR 98.4 million, a 4.6% increase from EUR 94.1 million in 2024, driven by the travel segment [15] - IXCHIQ sales increased significantly to EUR 8.4 million from EUR 3.7 million in the prior year, including the supply of 40,000 doses to La Réunion [16] Market Data and Key Metrics Changes - The company noted a significant reduction in third-party sales from EUR 33.2 million to EUR 19.2 million due to the termination of distribution contracts [16] - Other revenues increased from EUR 6.3 million to EUR 16.8 million, driven by a EUR 10 million revenue recognition related to a license agreement with Pfizer [17] Company Strategy and Development Direction - Valneva aims to become a leading vaccine biotech company by focusing on growing its commercial business and optimizing cash generation [5] - The company is advancing its Lyme disease vaccine candidate, VLA15, which represents a significant opportunity in an underserved market [6] - Valneva plans to expand beyond vector-borne diseases and is exploring in-licensing opportunities to enhance its R&D pipeline [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Lyme disease vaccine, with positive phase 3 results expected to be transformational for the company [22] - The company anticipates total product sales in 2026 to be between EUR 145 million and EUR 160 million, reflecting further planned reductions in third-party product sales [20] - Management emphasized the importance of cash management and reducing operating cash burn as key focuses moving forward [20] Other Important Information - Valneva achieved a more than 20% reduction in operating cash burn through disciplined cash management [5] - The company is investing in the further development of IXCHIQ and has initiated a pilot vaccination campaign in Brazil [10] Q&A Session Summary Question: When will Lyme data be available? - Management indicated that Pfizer controls the phase 3 study and expects data in the first half of 2026, with hopes for mid-H1 results [28] Question: What is the confidence level regarding VLA15's efficacy across different serotypes? - Management stated that preclinical models have shown promising results, but human data is still needed to confirm efficacy across serotypes [32] Question: What is the status of the DoD contract for IXIARO? - Management confirmed that a new contract is expected this year, and it is included in the revenue guidance for 2026 [63] Question: What are the criteria for ACIP recommendations for VLA15? - Management noted that ACIP recommendations depend on safety and efficacy data, with a focus on high-risk populations [44] Question: What are the next steps for IXCHIQ in Asia? - Management is evaluating potential partners and commercialization strategies for IXCHIQ in Asia, with announcements expected later this year [68]

Full Year 2025 Financial Results and Business Update Disclaimer A Leading Specialty Vaccine Company This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United States. Financial sta ...