Candel's CAN-2409 Achieves Phase III Success, Boosting Stock Amid Regulatory Hopes

Candel Therapeutics' recent success in the Phase III trial of CAN-2409 marks a significant milestone for the company, as the investigational immunotherapy achieved its primary endpoint, substantially boosting its stock by more than 200%[1][2]. The study enrolled 745 patients with intermediate-to-high-risk localized prostate cancer who received CAN-2409 in combination with valacyclovir and standard radiation therapy. This regimen led to a statistically significant 14.5% relative improvement in disease-free survival (DFS), with a hazard ratio of 0.7 and a p-value of 0.0155 compared to placebo[1][2]. The results, underpinned by a special protocol assessment from the FDA, lay a potential pathway for regulatory approval, although certain challenges, such as the higher observed death rate in the treatment group not directly linked to prostate cancer, might emerge during the regulatory process[1][2].