Candel Therapeutics Inc. Stock Surges Amid Regulatory Milestone and Positive Clinical Data

Candel Therapeutics, Inc. (CADL), a late clinical-stage biopharmaceutical company based in Needham, Massachusetts, has experienced a notable surge in its stock price on Wednesday, May 28, 2025. The company, which specializes in developing oncolytic viral immunotherapies for cancer treatment, has recently received significant regulatory and clinical updates that have positively impacted investor sentiment.

Regulatory Milestone: FDA RMAT Designation

On the same day, Candel Therapeutics announced that it had received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for its lead candidate, CAN-2409, aimed at treating prostate cancer. This designation is a critical regulatory milestone that could expedite the development and review process for CAN-2409. The RMAT designation, along with the previously granted Fast Track status, establishes an expedited regulatory pathway, potentially accelerating the timeline for bringing this biological immunotherapy to market.

The Phase 3 clinical trial data supporting this designation demonstrated compelling results. The trial showed a statistically significant 30% reduction in the risk of cancer recurrence or death (HR 0.70, p=0.0155) and a 38% reduction in prostate-specific disease-free survival (HR 0.62, p=0.0046). Additionally, the trial reported a significantly higher pathological complete response rate of 80.4% compared to 63.6% for the placebo group. The achievement of a prostate-specific antigen (PSA) nadir was also better in the CAN-2409 group (67.1%) compared to the placebo group (58.6%), with a consistent safety profile and no new safety concerns.

Despite these positive developments, Candel Therapeutics does not expect to submit a Biologics License Application (BLA) until the end of 2026, indicating a lengthy timeline to potential approval.

Investor Conference Call

In related news, Candel Therapeutics announced that it will host an investor conference call on June 3, 2025, to discuss the positive Phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer. The call will follow Dr. Theodore DeWeese’s oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The discussion will feature insights from leading prostate cancer specialists, including Dr. John E. Sylvester and Dr. Ronald F. Tutrone, Jr., who were principal investigators on the Phase 3 clinical trial.

Company Overview

Candel Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer. The company is listed on the Nasdaq under the ticker symbol CADL. As of May 26, 2025, the close price of Candel Therapeutics stock was $5.6, with a 52-week high of $14.6 on December 10, 2024, and a 52-week low of $3.785 on November 14, 2024. The company’s market capitalization stands at approximately $271.56 million, with a price-to-earnings ratio of -4.05.

These recent developments have significantly boosted investor confidence in Candel Therapeutics, as reflected in the surge of its stock price. The company continues to focus on advancing its pipeline of innovative cancer therapies, with CAN-2409 being a key candidate in its portfolio.