French laboratory Valneva is down 3.93% at 4.16 euros this Wednesday midday, marking one of the steepest declines in the SBF 120. This stock market setback follows the announcement on Sunday evening of the voluntary withdrawal of authorization applications for its IXCHIQ chikungunya vaccine in the United States. This decision comes after the FDA suspended the license in August 2025 and initiated an investigation into a new serious adverse event reported abroad. However, the vaccine continues to be marketed in Europe, Canada, the United Kingdom, and Brazil.
Impact of the American Withdrawal on Midday Trading
The announcement of the American withdrawal heavily impacts Valneva's share price at midday, with a decline of nearly 4%. The stock is experiencing one of the sharpest falls in the SBF 120 during the session, with significant pressure around midday. According to Stifel, this decision seems rational given the limited visibility on a resumption of marketing and the now tarnished image of the vaccine. Technically, the RSI reached 70, indicating an overbought zone prior to this correction, while the share price was above its 50-day moving average set at 3.89 euros. The breach of the resistance threshold at 4.43 euros is now compromised in the short term, with a decline bringing the value back towards its intermediate support.
Analyst Recommendations Remain Mixed
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Analyst recommendations for Valneva remain mixed. Stifel maintains a buy recommendation with a target raised to 10 euros, having already removed Ixchiq's U.S. sales from its model since last August and now expects a sales peak of about 25 million euros for the European Union alone. On the other hand, Goldman Sachs holds a neutral stance with a lowered target of 3.25 euros, indicating a potential downside of 22% from the current price. Investors' attention is now turning to the Lyme disease vaccine, co-developed with Pfizer, with authorization applications expected in 2026 from both U.S. and European authorities. Stifel anticipates a commercial launch by the end of 2027 and estimates potential sales of 1.9 billion euros, a projection that could breathe new life into the case in the coming quarters.
Au troisième trimestre, nous avons continué à nous concentrer sur le renforcement de notre trésorerie, ce qui nous a permis de refinancer notre dette à des conditions financières plus avantageuses.
Chiffre d’affaires de 127,0 millions d’euros sur neuf mois (+8,9 %), ventes de 119,4 millions d’euros, trésorerie de 143,5 millions d’euros au 30/09/2025, perte nette 65,2 millions d’euros, EBITDA ajusté (37,7) millions d’euros. Guidance 2025 confirmée : chiffre d’affaires attendu entre 165 et 180 millions d’euros; ventes attendues entre 155 et 170 millions d'euros. Renforcement de la position financière via refinancement et ATMs; Phase 3 VALOR pour le vaccin Lyme en cours selon calendrier.
Risks mentioned
Suspension de la licence IXCHIQ ® aux États-Unis par la FDA (impact sur ventes segment voyageurs)
Risque de résultats cliniques défavorables pour les candidats (phase 3 VALOR pour Lyme, essais S4V2, VLA1601 incertitudes réglementaires)
Exposition aux fluctuations de change (impact négatif mentionné de 1,3 millions d’euros sur ventes, effets de change volontaires)
Dépendance à des partenaires de distribution et diminution des produits de tiers (arrêt de distribution de Rabipur/RabAvert et Encepur)
Opportunities identified
Résultats positifs potentiels de la Phase 3 VALOR (VLA15) pouvant mener à des demandes d'autorisation en 2026
Accord commercial avec CSL Seqirus en Allemagne pour stimuler la commercialisation des vaccins
Croissance des ventes d'IXCHIQ ® sur les marchés hors États-Unis et dans les PRFI (livraisons de substance active)
Potentiel du candidat S4V2 contre la shigellose (marché estimé > 500 millions de dollars/an)
Données positives de Phase 1 pour VLA1601 (Zika) et forte persistance d'anticorps pour IXCHIQ ® (95 % à 4 ans) comme avantage concurrentiel
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