$VALN

Valneva (VALN) reported H1 2026 results with €64M in product sales, a net loss of €63.3M, and reaffirmed 2026 guidance. Sales declines were driven by reduced distribution activities and lower travel vaccine demand. The company is focusing on cash preservation and expects regulatory decisions for its Lyme disease vaccine candidate within 12 months, according to management.

Valneva (VALN) reported H1 2026 results: €64M product sales, €63.3M net loss, and €121.5M cash. Sales declined due to reduced distribution and lower IXIARO (€44M) and DUKORAL (€14.7M) revenues. Gross margins fell for both vaccines. The company reaffirmed 2026 guidance: €135M-€150M product sales, €145M-€160M total revenue. Pfizer expects EMA decision on Lyme disease vaccine within 12 months. Valneva is restructuring, consolidating R&D in Vienna, and focusing on cash preservation.

The EMA validated Pfizer and Valneva’s marketing authorization application for their Lyme disease vaccine candidate PF-07307405 and will begin formal review. The submission relies on Phase III VALOR data from 9,437 participants, showing over 70% efficacy and no identified safety concerns, according to the companies. Pfizer holds exclusive manufacturing and commercialization rights if approved.

Lyme disease cases in Canada rose from 144 in 2009 to 5,809 in 2024, with 7,105 preliminary cases for 2025, according to PHAC data. The article says no human Lyme vaccine is currently approved. Pfizer and Valneva’s PF-07307405 completed Phase 3 with over 70% efficacy after four doses, and Moderna has Phase 2 candidates mRNA-1975 and mRNA-1982.

European stocks ended mixed as Middle East conflict and uncertainty around the Strait of Hormuz weighed on sentiment, while easing concerns about Fed rates followed tame US inflation. Stoxx 600 fell 0.21%, with CAC 40 down 0.16% and DAX up 0.53%. UK’s Sage Group rose 4.5%. Valneva jumped 20% after EMA validated its Lyme vaccine application.

Midday Aug. 14 market update: S&P 500 -0.21% to 7,782.65 and Nasdaq -0.50% to 26,664.30, with stocks pressured by falling consumer confidence. Reddit rose 14% after news it will join the S&P 500. Valneva gained 22% on earnings and regulator validation. T-Mobile US fell on a brokerage downgrade.

Pfizer and Valneva said the European Medicines Agency will review their experimental Lyme disease vaccine, PF-07307405. The companies reported trial results showing about 70% effectiveness in people aged 5 and older, with no approved vaccine currently. Valneva shares rose nearly 16% in Paris after the announcement.

EU officials agreed to study an experimental Lyme disease vaccine, according to Pfizer and Valneva. The firms said trials showed about 70% efficacy in ages 5+ and that the European Medicines Agency accepted an approval application for PF-07307405. Valneva shares rose about 16% in Paris trading.

The article says reported Lyme disease cases in Canada rose from 144 in 2009 to 5,809 in 2024, with 2025 preliminary cases at 7,105, citing PHAC data. It notes no human Lyme vaccine is currently approved. It describes Pfizer and Valneva’s co-developed vaccine PF-07307405 completing Phase 3 as of March 2026, and Moderna’s mRNA-1975 and mRNA-1982 in Phase 2.

Valneva shares rose 15.6% to €2.837 after the European Medicines Agency validated its marketing authorization application for PF-07307405, a 6-valent Lyme vaccine co-developed with Pfizer. The filing is based on Phase 3 VALOR data showing over 70% efficacy and no major safety issues. The move followed Valneva’s H1 2026 net loss of €63.3 million, while it reiterated €135–€150 million sales guidance and €121.5 million cash.