Valneva Shares Slide After FDA Suspension Prompts Guidance Revision

Shares of Valneva SE (NASDAQ:VALN) dropped 6.4% on Tuesday after the French vaccine developer revised its 2025 financial outlook downward following the U.S. FDA’s suspension of the product license for its IXCHIQ vaccine.

The company now anticipates product sales of €155–170 million, down from its earlier projection of €170–180 million. Total revenue guidance has been reduced to €165–180 million from €180–190 million, while research and development spending is expected to range between €80–90 million, compared to the previous €90–100 million forecast.

Valneva attributed the revision to “ongoing uncertainty” as it awaits additional information from the FDA regarding the IXCHIQ suspension. Despite the guidance cut, the company emphasized that its commercial operations remain on track to deliver positive cash flow.

In a separate announcement, Valneva said it had secured a new debt facility of up to $500 million with Pharmakon Advisors, LP. The first $215 million tranche will be used to repay existing debt owed to Deerfield Management Company and OrbiMed, while the remaining $285 million will be available to support future growth and business development initiatives.

The new financing package extends the company’s debt maturity profile from Q1 2026 to Q4 2030 and provides improved terms, including a lower interest rate and a bullet maturity structure after five years.

Meanwhile, Valneva confirmed that the Phase 3 trial of its Lyme disease vaccine candidate, being co-developed with Pfizer (NYSE:PFE), is progressing as planned. The companies still intend to file regulatory submissions in 2026, with a potential market launch in the second half of 2027, pending approval.

Valneva stock price

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