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Valneva Shares Surge 5.5% at Close Following Promising Results

Valneva's stock closed on Thursday, November 27 at 4.30 euros, up by 5.5% from the previous day. This surge followed the announcement on Wednesday of positive final Phase 2 results for its Lyme disease vaccine candidate, developed in partnership with Pfizer. The traded volumes accounted for 0.78% of the capital, while the CAC 40 saw a marginal increase of 0.04% to 8,099.47 points.


Valneva Shares Surge 5.5% at Close Following Promising Results

Positive Final Data Announced for Phase 2 Lyme Disease Vaccine Candidate

Valneva announced on November 26 positive final immunogenicity and safety data for the Phase 2 study VLA15-221 of its Lyme disease vaccine candidate VLA15. The results demonstrated a strong anamnestic immune response and a favorable safety profile six months after a third booster dose across all age groups. This announcement comes at a favorable time for the French biotech: the stock has now increased by 15.1% over a week and 127.3% over a year, significantly outperforming the CAC 40, which gained 12.58% over the same annual period. Currently, there is no human vaccine against Lyme disease, and VLA15 is the most advanced vaccine candidate against this disease, with two ongoing Phase 3 trials. The U.S. Centers for Disease Control and Prevention estimate that about 476,000 people are diagnosed and treated for Lyme disease each year in the United States and 132,000 cases are reported annually in Europe. Subject to positive Phase 3 data, Pfizer plans to submit marketing authorization applications to the FDA and the European Medicines Agency in 2026. The prospect of potential commercialization of the vaccine in 2026 fuels investor optimism.

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Technically, the stock is now trading above its 50-day moving average set at 4.20 euros, a bullish signal confirming the positive trend initiated in recent weeks. The RSI stands at 64, in a zone of positive dynamics without reaching the overbought zone, suggesting that a continued rise is possible in the short term. The stock's volatility remains high with a one-month indicator at 11.62, characteristic of biotechnological values subject to clinical and regulatory uncertainties. The MACD displays an encouraging signal with a positive histogram at 0.04, indicating the beginning of a bullish divergence between the MACD line and its signal line. The price is also moving above the lower Bollinger band set at 3.63 euros, gradually approaching the resistance threshold at 4.45 euros. A breakout of this level could pave the way for a continuation of the upward movement, although the presence of a net short position representing about 0.60% of the capital signals persistent caution among some market players.

Mixed Operational Context for the Franco-Austrian Laboratory

The operational context remains mixed for the Franco-Austrian laboratory. The group reported a revenue of 127 million euros over nine months, in an environment marked by the immediate suspension by the U.S. FDA of the license for IXCHIQ, its chikungunya vaccine, which entails a halt to shipments and sales in the United States. This vaccine contributed 7.5 million euros to total sales in the first half of 2025. Despite this setback, movements of executives reveal a mixed sentiment with a purchase of 3,750 shares for about 14,927 euros, against three sales representing 18,380 shares for 82,129 euros. The quarterly performance remains solid with a 12.68% increase over three months. Investors are now betting on the commercial potential of VLA15, whose clinical data strengthen its credibility in the race towards the first approved vaccine against Lyme disease, a market estimated at several hundred million euros annually in North America and Europe.



Sector Santé · Pharmacie Industrie Pharmaceutique


Assurance vie

Context

Period
  • Period: 9M 2025
Guidance from the release
  • 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

The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.

Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.

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