CADL Stock Tumbles 38% After-Hours As Candel Pushes Prostate Cancer FDA Application Timeline To Mid-2027

• The company now expects to file the application in the middle of 2027, pending the outcome of those discussions.
• Candel had previously said that it would submit the application in the fourth quarter of 2026. 
• In its pivotal late-stage trial, Candel’s aglatimagene plus external beam radiation therapy delivered a 41% reduction in the risk of recurrence or prostate cancer-specific death versus radiation alone in intermediate-risk patients, after a median 58 months of follow-up.

Shares of Candel Therapeutics (CADL) sold off 38% in after-hours trading on Thursday after the company said ongoing discussions with the U.S. Food and Drug Administration (FDA) have delayed its planned Biologics License Application for lead candidate aglatimagene besadenovec in localized prostate cancer.

The stock closed the regular session at $8.39, down 9% from the prior close, before plummeting after hours.  

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BLA Discussions And Timeline Shift

Candel said it is in continuing dialogue with the FDA regarding the BLA submission for aglatimagene in intermediate- to high-risk localized prostate cancer. Because of timelines tied to certain assay refinements, the company now expects to file the application in the middle of 2027, pending the outcome of those discussions. The company had previously said that it would submit the application in the fourth quarter of 2026.

This BLA is central to Candel’s strategy. The company has described Aglatimagene as potentially the first new therapy in the localized prostate cancer setting in more than two decades. A successful filing and approval would move the company from clinical-stage development to commercialization. The company is also studying Aglatimagene in non-small cell lung cancer.

In its pivotal late-stage trial, Candel’s aglatimagene plus external beam radiation therapy delivered a 41% reduction in the risk of recurrence or prostate cancer-specific death versus radiation alone in intermediate-risk patients, after a median 58 months of follow-up. The study also showed supporting signals, including higher rates of negative biopsies at two years.

Third-Quarter Results And Cash Position

For the quarter ended September 30, CADL’s research and development expenses rose to $15.6 million from $8.5 million a year earlier, driven by higher clinical trial and manufacturing costs for the aglatimagene programs. General and administrative expenses increased to $7.4 million from $4.7 million, reflecting added headcount and commercial-readiness spending. The company’s net loss, as a result, widened to $21.9 million from $11.3 million.

Cash and cash equivalents stood at $203.1 million at quarter-end. Management said this balance is expected to fund the current operating plan into the second quarter of 2028.

How Did CADL Retail Traders React?

On Stocktwits, retail sentiment around CADL stock stayed within the 'extremely bullish' territory over the past 24 hours, while message volume jumped from 'high' to 'extremely high' levels.

A Stocktwits user floated the idea that the company might be more attractive to buyers following the selloff.

Another user pinned the selloff to investors’ loss of trust in management over the delay in BLA filing. He also highlighted CEO Paul Peter Tak selling $3.16 worth million worth of CADL shares in September.  

CADL stock has gained 48.5% year-to-date. 

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