CADL Up as FDA Grants RMAT Status to CAN-2409 in Prostate Cancer

Core Insights - Candel Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational adenovirus immunotherapy candidate, CAN-2409, aimed at treating newly diagnosed localized prostate cancer in patients with intermediate-to-high risk [1][3] - The RMAT designation was based on positive results from a phase III study that demonstrated the safety and efficacy of CAN-2409 in combination with a prodrug and standard of care radiation therapy [2][6] - Following the announcement, Candel's shares increased by 6.1%, although the stock has seen a year-to-date decline of 31.6%, contrasting with the industry's decline of 4.9% [3][4] Company Developments - The phase III study met its primary endpoint, showing statistically significant improvement in disease-free survival for patients receiving the combination therapy compared to standard of care alone [6] - Treatment with CAN-2409 was well tolerated, with no new safety signals identified, leading the company to plan a Biologics License Application (BLA) submission by the end of 2026 [7] - Candel is also exploring CAN-2409 in mid-stage studies for pancreatic and non-small cell lung cancer indications, in addition to its focus on prostate cancer [8] Market Position - Candel currently holds a Zacks Rank of 2 (Buy), indicating a favorable outlook within the biotech sector [9] - Other biotech stocks with a similar ranking include Lexicon Pharmaceuticals, Chemomab Therapeutics, and Amarin, each also carrying a Zacks Rank of 2 [9]