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Candel eyes 2026 U.S. filing for CAN-2409 after Phase 3 success and FDA RMAT status

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Manage episode 500316104 series 2891889
Content provided by Proactive Investors. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Proactive Investors or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
Candel Therapeutics CEO Dr. Paul Peter Tak joined Steve Darling from Proactive to discuss the company’s second quarter results and upcoming milestones, highlighted by plans to seek U.S. approval for its lead cancer therapy CAN-2409 in late 2026. The filing follows the success of a pivotal Phase 3 prostate cancer trial and the FDA’s decision to grant the therapy Regenerative Medicine Advanced Therapy designation. The company reported a narrower loss for the quarter, supported by strong clinical data and new financing that extends its cash runway into early 2027. Candel closed the quarter with $100.7 million in cash, positioning the company to continue advancing late-stage development while preparing for launch readiness activities. CAN-2409, an investigational immunotherapy, is being tested across multiple tumor types. In prostate cancer, the therapy demonstrated a 30% improvement in disease-free survival compared with placebo when combined with radiation, under an FDA-agreed trial protocol that could support a Biologics License Application (BLA). Beyond prostate cancer, CAN-2409 also showed promising survival benefits in pancreatic and non-small cell lung cancers, with some patients achieving durable long-term remissions. Candel is now preparing manufacturing and regulatory documentation to support a planned BLA submission for CAN-2409 in prostate cancer in the fourth quarter of 2026. At the same time, the company is progressing other pipeline assets, including CAN-3110 for recurrent high-grade glioma, where new clinical data are anticipated later this year. Dr. Tak emphasized that these achievements position Candel as a leader in advancing transformative immunotherapies for patients with difficult-to-treat cancers. #proactiveinvestors #candeltherapeuticsinc #nasdaq #cadl #CancerTreatment #ViralTherapy #ProstateCancer #PancreaticCancer #Glioblastoma #PaulPeterTak #ClinicalTrials #BiotechNews #Immunotherapy #Oncology #CancerResearch
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605 episodes

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Manage episode 500316104 series 2891889
Content provided by Proactive Investors. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Proactive Investors or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
Candel Therapeutics CEO Dr. Paul Peter Tak joined Steve Darling from Proactive to discuss the company’s second quarter results and upcoming milestones, highlighted by plans to seek U.S. approval for its lead cancer therapy CAN-2409 in late 2026. The filing follows the success of a pivotal Phase 3 prostate cancer trial and the FDA’s decision to grant the therapy Regenerative Medicine Advanced Therapy designation. The company reported a narrower loss for the quarter, supported by strong clinical data and new financing that extends its cash runway into early 2027. Candel closed the quarter with $100.7 million in cash, positioning the company to continue advancing late-stage development while preparing for launch readiness activities. CAN-2409, an investigational immunotherapy, is being tested across multiple tumor types. In prostate cancer, the therapy demonstrated a 30% improvement in disease-free survival compared with placebo when combined with radiation, under an FDA-agreed trial protocol that could support a Biologics License Application (BLA). Beyond prostate cancer, CAN-2409 also showed promising survival benefits in pancreatic and non-small cell lung cancers, with some patients achieving durable long-term remissions. Candel is now preparing manufacturing and regulatory documentation to support a planned BLA submission for CAN-2409 in prostate cancer in the fourth quarter of 2026. At the same time, the company is progressing other pipeline assets, including CAN-3110 for recurrent high-grade glioma, where new clinical data are anticipated later this year. Dr. Tak emphasized that these achievements position Candel as a leader in advancing transformative immunotherapies for patients with difficult-to-treat cancers. #proactiveinvestors #candeltherapeuticsinc #nasdaq #cadl #CancerTreatment #ViralTherapy #ProstateCancer #PancreaticCancer #Glioblastoma #PaulPeterTak #ClinicalTrials #BiotechNews #Immunotherapy #Oncology #CancerResearch
  continue reading

605 episodes

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