Valneva

Valneva shares jumped nearly 23% and climbed back above the 200-day moving average, cutting the year-to-date loss to 19%. The move follows positive Phase III data for the tick vaccine PF-07307405, developed with Pfizer; the European Medicines Agency is now reviewing it for approval. Jefferies analyst Maury Raycroft also sees FDA approval of the U.S. filing as likely and assigns a $15 price target to the U.S. warrants. » Mere på de.investing.com

Valneva reports a net loss of €63.3m for H1 2026, worsened gross margins, declining travel vaccine sales and one‑off charges, which caused revenue and operating profit to decline. The company lowered its 2026 product sales forecast to €135–150m and total revenue to €145–160m, citing weakening demand in key markets. The share price came under pressure after the report, while progress on the restructuring and the Lyme disease programme with Pfizer are seen as longer‑term catalysts. » Mere på de.investing.com

Valneva reported Q4 2025 EPS of -$0.24 (forecast -$0.3693) and revenue of $55.17m (expectation $50.56m); the stock rose 2.82% in pre-market trading to $11.32. The full-year results show total revenue of over €170m and a 9% increase in sales of its own products, while operating loss (€82.1m) and net loss (€115.2m) were weighed down by higher R&D spending. Valneva emphasizes focus on its vaccine portfolio, notably Lyme disease and chikungunya, expects Phase-3 data for Lyme disease in H1 2026 and forecasts revenue of around $204.39m for 2026. Risks remain regulatory approvals, market acceptance and geopolitical/structural challenges. » Mere på de.investing.com

Valneva reported total revenue of €174.7m for 2025 (2024: €169.6m) and growth in its own-product sales, while overall product revenues fell 3.3% to €157.9m. The decline was driven mainly by a 42% collapse in third-party distribution to €19.2m. For 2026 the company is guiding total revenue of €155–170m and product revenues of €145–160m, below consensus estimates; Valneva cites the ongoing wind-down of third-party product distribution as the reason. Cash and cash equivalents fell to €109.7m at year-end; hopes remain pinned on the Phase III VALOR study against Lyme disease and Phase II data for the Shigella candidate in H2 2026. » Mere på de.investing.com

Valneva voluntarily withdrew its BLA and IND applications for its chikungunya vaccine IXCHIQ in the US after the FDA imposed a clinical hold. The move follows an investigation of a recently reported serious adverse event abroad in an adult who received three vaccines simultaneously; a causal link to IXCHIQ is plausible but not definitively established. The stock fell about 6.6% in premarket trading. Valneva said it will gather further information and, after additional discussions with regulators, continue planned post‑marketing clinical activities; the benefit‑risk profile for already approved regions remains favorable. » Mere på de.investing.com