Valneva SE faces significant setbacks in its Chikungunya program and pivots to Lyme disease collaboration

Valneva SE announced on 19 January 2026 the voluntary withdrawal of its Biologics License Application (BLA) and Investigational New Drug (IND) application for the Chikungunya vaccine IXCHIQ® in the United States. The decision followed a clinical hold imposed by the U.S. Food and Drug Administration (FDA) after a serious adverse event (SAE) reported outside the United States. Although Valneva stated that causality between the event and the vaccine had not yet been established, the withdrawal effectively ended the company’s prospects of entering the lucrative U.S. market for the product.

The loss of the U.S. regulatory pathway has weighed heavily on investor sentiment. On 25 January, the share price fell 6.38 %, closing at €4.11. The decline coincided with news that Danish competitor Bavarian Nordic secured exclusive distribution rights for its own Chikungunya vaccine, IXELISA, with Eurofarma in Brazil. Bavarian Nordic’s announcement of a market launch in the second half of 2027 further intensified pressure on Valneva’s Chikungunya strategy. As a result, Valneva’s relative strength index (RSI 14) was reported at 18.9, indicating a strongly oversold condition.

In response to the setback, Valneva shifted focus toward its Lyme disease portfolio in collaboration with Pfizer. The company has entered into a strategic partnership to develop a Lyme vaccine, positioning the project as a potential “blockbuster” candidate. This pivot reflects a deliberate move away from the troubled Chikungunya program toward a product area with higher perceived growth prospects and established commercial partnerships.

Key dates and actions

  • 19 January 2026 – Voluntary withdrawal of BLA and IND for IXCHIQ® in the U.S.
  • 25 January 2026 – Stock price drops 6.4 % to €4.11 amid competitor gains.
  • 23 January 2026 – Company issues statement highlighting shift to Lyme disease collaboration with Pfizer.

Valneva’s market capitalization remains at approximately €712 million, and its price‑earnings ratio is currently negative at –7.55, reflecting the ongoing challenges in its vaccine pipeline. The company’s stock remains listed on the NYSE Euronext Paris and trades in euros. The latest closing price on 22 January 2026 was €4.106, down from a 52‑week high of €5.415 and above its 52‑week low of €2.236.

The company’s executive team has emphasized that the withdrawal of the U.S. filings does not affect ongoing development activities in other regions, including the European and Asian markets, where several vaccine candidates are in clinical or pre‑clinical stages. Valneva’s core competencies—its EB66 production cell line and IC31 adjuvant platform—continue to underpin its vaccine development strategy across infectious diseases such as clostridium difficile, chikungunya, and zika, in addition to the new Lyme focus.

Investors will monitor the progress of the Lyme vaccine partnership and the company’s ability to regain regulatory confidence for its other product candidates. Any further regulatory decisions, especially regarding the U.S. market or the status of the Chikungunya program, are likely to exert immediate influence on Valneva’s share price and market perception.