Candel Therapeutics CADL Soars 6.07% on FDA RMAT Designation

Candel Therapeutics (CADL) surged 6.07% today, marking its third consecutive day of gains, with a cumulative increase of 9.59% over the past three days. The share price reached its highest level since March 2025, with an intraday gain of 12.32%.

The strategy of buying CADL shares after they reached a recent high and holding for 1 week yielded moderate returns over the past 5 years, with a 7.5% annualized gain. However, the overall performance was slightly underwhelming, with a 5-year total return of 37.5%, compared to the NASDAQ's 45.6% return over the same period. This suggests that while the strategy provided some growth, it may not have fully capitalized on broader market gains. The recent 8% gain following the FDA RMAT designation highlights the potential for stronger returns based on clinical milestones.

Candel Therapeutics' stock price has been significantly influenced by recent regulatory developments. On May 28, 2025, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409, the company's lead biological immunotherapy candidate for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. This designation is aimed at accelerating the development and review of regenerative medicine therapies that address unmet medical needs for serious or life-threatening diseases.

The RMAT designation was supported by positive data from Candel's phase 3 clinical trial, which demonstrated statistically significant improvements in disease-free survival and other key measures. This clinical success has likely contributed to the recent surge in the company's stock price, as investors anticipate the potential for faster regulatory approval and market entry for CAN-2409.

The RMAT designation is a significant milestone for Candel Therapeutics, as it not only expedites the regulatory process but also enhances the company's credibility and attractiveness to potential partners and investors. The designation underscores the therapeutic potential of CAN-2409 and positions Candel Therapeutics as a leader in the development of innovative treatments for prostate cancer.