If the FDA approves aglatimagene besadenovec in the treatment of certain patients with prostate cancer, it would mark the company’s first commercial product.
- The company is preparing a Biologics License Application for aglatimagene besadenovec in intermediate- to high-risk localized prostate cancer, targeting submission in the fourth quarter of 2026.
- Earlier this week at the Canaccord Genuity Growth Conference, Chief Scientific Officer Dr. Francesca Barone said that the company sees a $10–16 billion opportunity for the therapy among patients whose main treatment is radiation therapy.
- Candel, in the meantime, is also advancing aglatimagene besadenovec in other indications.
Shares of Candel Therapeutics (CADL) rose as much as 7% on Thursday before paring some gains as the company moves steadily toward filing an application to the U.S. Food and Drug Administration seeking approval for its experimental prostate cancer therapy.
The company, which is still in the clinical stage, ended the second quarter with no product revenue and a loss per share of $0.52, compared to $0.09 in the corresponding period last year. If the FDA approves aglatimagene besadenovec in the treatment of certain patients with prostate cancer, it would mark the company’s first commercial product.
Cash and cash equivalents stood at $201.6 million as of June 30, expected to fund operations into the first quarter of 2028—including activities supporting a potential 2027 launch for aglatimagene besadenovec, the company said.
Path To Regulatory Filing And Launch
The company is preparing a Biologics License Application for aglatimagene besadenovec in intermediate- to high-risk localized prostate cancer, targeting submission in the fourth quarter of 2026. A potential U.S. commercial launch could follow in 2027. Manufacturing and process validation are advancing, the company said.
Earlier this week at the Canaccord Genuity Growth Conference, Chief Scientific Officer Dr. Francesca Barone said the company sees a $10–16 billion opportunity for the therapy among patients whose primary treatment is radiation therapy rather than surgery.
CEO Paul Peter Tak said the second quarter “reflects meaningful execution” toward the BLA and commercial foundation, noting that extended late-stage follow-up data and publication in The Lancet Oncology reinforce the drug’s potential to address an unmet need.
Other Pipeline Advancements
Candel, in the meantime, is also advancing aglatimagene besadenovec in other indications. Enrollment has opened in the global late-stage AURORA trial of aglatimagene for advanced non-squamous non-small cell lung cancer, evaluating it with pembrolizumab versus docetaxel, with overall survival as the primary endpoint.
The company also continues enabling work for a potential randomized mid-stage study of linoserpaturev in recurrent glioblastoma, with longer-term survival data expected later this year.
How Did CADL Retail Traders React?
On Stocktwits, retail sentiment around CADL stock rose from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘high’ levels.
A Stocktwits user said the stock will eventually explode.
Another user expressed optimism that the company would be bought out by Johnson & Johnson at a significant premium.
CADL stock has nearly doubled year-to-date.
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