StocksMedium•12 November 2026•
1 min read
Candel Therapeutics Shares Sink 38% on Delayed FDA Application Timeline
Key Facts
1Candel shares dropped 38% in after-hours trading after the company pushed its Biologics License Application (BLA) timeline to mid-2027.
2The company previously expected to submit the application in Q4 2026, but ongoing discussions with the FDA necessitated the delay.
Candel shares dropped 38% in after-hours trading after the company pushed its Biologics License Application (BLA) timeline to mid-2027. Asianet Newsable reported that the company previously expected to submit the application in the fourth quarter of 2026, but ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding required assay refinements necessitated the delay.
Candel stock experienced a sharp sell-off following the announcement, having closed the regular session at $8.39 on November 12, 2026. This regulatory delay comes as the company's net loss widened to $21.9 million from $11.3 million a year earlier, driven by higher clinical trial and manufacturing costs for its aglatimagene programs.