Published Phase 3 data in Lancet Oncology showed CAN-2409 plus radiotherapy improved prostate cancer-specific disease-free survival by 38% in a 745-patient trial with mild-to-moderate side effects, supporting a planned BLA submission in Q4 2026. Analysts set an average 12-month price target implying 111% upside and shares are up 57% YTD.
The pivotal Phase 3 trial enrolled 745 patients with localized prostate cancer and met its primary endpoint, demonstrating a 38% improvement in prostate cancer-specific disease-free survival and a 30% increase in overall disease-free survival for patients receiving CAN-2409 plus standard radiotherapy compared with radiotherapy alone. The therapy exhibited a favorable safety profile, with most treatment-related side effects classified as mild or moderate and transient.
Candel plans to submit a Biologics License Application in Q4 2026 based on these pivotal results. The company indicated the published data will form the core of the regulatory submission, advancing its pathway toward commercial approval of the therapy for prostate cancer.
Wall Street analysts assigned an average 12-month price target implying 111% upside and maintained a Strong Buy consensus, with eight of nine analysts recommending buy and one hold. Retail investor sentiment has shifted bullish, driving shares up 57% year-to-date and positioning the stock for its best weekly performance in over a month.
