Candel's CAN-2409 Shows Promising Phase III Results, Boosts Stock Despite Challenges

Candel Therapeutics has announced that its investigational therapy, CAN-2409, successfully achieved the primary endpoint in its Phase III trial involving 745 patients with intermediate-to-high-risk localized prostate cancer[1][2]. This trial demonstrated a statistically significant 14.5% improvement in disease-free survival when CAN-2409 was administered alongside valacyclovir and standard radiation therapy[1]. Although the primary endpoint is non-traditional, Candel is bolstered by a Special Protocol Assessment with the FDA, potentially paving the way for a regulatory application and prospective approval by 2026[1][2].
References
Explore Further
What are the specific challenges Candel Therapeutics faces in gaining regulatory approval after the Phase II trial setbacks?
How does Candel plan to mitigate the risks identified in the unsuccessful CAN-2409 Phase II trial?
What role did the FDA's Special Protocol Assessment play in Candel's strategy for CAN-2409's Phase III trial?
How might the success in Phase III trials affect the future research and development strategy of Candel Therapeutics?
What are Candel Therapeutics' plans for maintaining funding until potential FDA approval in 2026?