Candel Therapeutics, Inc. (CADL) has disclosed a new risk, in the Innovation / R&D category.
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Candel Therapeutics, Inc. faces a significant business risk despite receiving the Regenerative Medicine Advanced Therapy (RMAT) Designation from the FDA for CAN-2409, aimed at treating newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. This designation does not guarantee a faster development, regulatory review, or approval process, nor does it increase the likelihood of marketing approval for CAN-2409 or any future product candidates. The FDA retains broad discretion in granting RMAT status, and there is no assurance that future candidates will receive this designation, which could impact the company’s strategic development plans. Furthermore, the FDA may withdraw the RMAT Designation at any time, adding another layer of uncertainty to the approval process.
The average CADL stock price target is $21.00, implying 247.68% upside potential.
To learn more about Candel Therapeutics, Inc.’s risk factors, click here.