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

Candel Therapeutics CADL announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational adenovirus immunotherapy candidate, CAN-2409 (aglatimagene besadenovec), for treating newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk of the disease.

The RMAT tag was granted based on positive data from a phase III study, which evaluated the safety and efficacy of CAN-2409+prodrug (valacyclovir)+standard of care (SOC) radiation therapy in the given patient population.

The RMAT designation is generally granted by the FDA to therapies that are intended to treat or cure a serious or life-threatening disease and have the potential to address unmet medical needs. It enables early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application (“BLA”).

Shares of Candel were up 6.1% yesterday following the announcement of the news.

The sock has lost 31.6% so far this year compared with the industry’s decline of 4.9%.

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CADL Focuses on BLA Submission for CAN-2409

In December 2024, Candel announced positive data from the above-mentioned phase III study on the CAN-2409 combo.

The study met its primary endpoint, demonstrating statistically significant improvement in disease-free survival in patients receiving the combination therapy of CAN-2409+prodrug (valacyclovir)+SOC compared to SOC alone.

Treatment with CAN-2409 was overall well tolerated and demonstrated a safety profile consistent with previous studies. No new safety signals were identified either.

Based on this data, the company plans to submit a BLA for CAN-2409 for treating intermediate-to-high-risk localized prostate cancer patients by the end of 2026. Per management, CAN-2409 has the potential to transform the treatment paradigm in prostate cancer.

The FDA has already granted a Fast Track designation to CAN-2409 for treating localized primary prostate cancer.

Besides prostate cancer, Candel is also evaluating CAN-2409 in separate mid-stage studies for treating pancreatic and non-small cell lung cancer indications.

CADL's Zacks Rank & Other Stocks to Consider

Candel currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are Lexicon Pharmaceuticals LXRX, Chemomab Therapeutics CMMB and Amarin AMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 5.3%.

LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.

In the past 60 days, estimates for Chemomab Therapeutics’ loss per share have narrowed from 70 cents to 60 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 80 cents to 70 cents. Year to date, shares of CMMB have declined 24.3%.

CMMB’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 5.00%.

In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 16.4%.

AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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