Candel Therapeutics, Inc. shares fell as much as approximately 39% in after-hours trading on November 12, 2026, after the Company announced, alongside its third-quarter results, that it now plans to submit the Biologics License Application for aglatimagene, its lead prostate cancer drug, in mid-2027. The Company attributed the revised timeline to timelines associated with assay refinement and to ongoing discussions with the U.S. Food and Drug Administration. In the months before that announcement, the Company had described manufacturing process validation as progressing well and had said the inputs for the Biologics License Application remained on track for submission in the fourth quarter of 2026, statements made during a period in which the Company was also selling stock to the public. On the same evening as the delay announcement, the Company entered into a new $50 million stock sale agreement. The question raised by the sequence is what the Company understood about the assay refinement work, and at what point, measured against the submission timing it had been describing to the market. The investigation concerns whether Candel Therapeutics adequately disclosed the status of assay refinement and the readiness of its Biologics License Application for aglatimagene ahead of its November 12, 2026 announcement that the submission had moved to mid-2027.