On Wednesday, H.C. Wainwright adjusted its outlook on Candel Therapeutics Inc. (NASDAQ: CADL), raising the stock's price target to $19.00 from the previous $11.00, while reaffirming a Buy rating. The stock has shown remarkable momentum, with a 464% return over the past year and a 349% gain year-to-date, according to InvestingPro data. This change follows the announcement of successful results from a critical Phase 3 clinical trial involving Candel's CAN-2409 for the treatment of localized prostate cancer.
The trial, which included 745 participants, achieved its primary endpoint by showing a statistically significant improvement in disease-free survival (DFS) for patients using CAN-2409 in combination with standard of care therapies, compared to standard care alone. The data indicated a 14.5% relative improvement in DFS at 54 months.
The study was conducted under a Special Protocol Assessment (SPA) with the FDA, which had already agreed to the primary endpoint in 2023. The positive outcome of the trial could potentially be sufficient for Candel to seek regulatory approval for CAN-2409 as an immunotherapy for patients with intermediate-to-high risk localized prostate cancer.
The analyst from H.C. Wainwright noted the increased likelihood of CAN-2409 receiving regulatory approval, now estimated at 85% compared to the previous 35%. This optimism is based on the expectation of favorable discussions between Candel Therapeutics and the FDA regarding the recent trial results.
Candel Therapeutics' shares are expected to respond to the company's enhanced prospects for CAN-2409's approval and commercialization as an off-the-shelf immunotherapy option for prostate cancer patients. The revised price target reflects the analyst's confidence in the drug's path forward.
In other recent news, Candel Therapeutics, Inc. has been making significant strides in the biopharmaceutical sector.
The company has announced the pricing of an $80 million public offering, consisting of 10 million shares of common stock and pre-funded warrants for over 3.3 million shares. This move follows a positive outcome from a phase 3 clinical trial evaluating CAN-2409, a viral immunotherapy, in combination with radiation therapy for treating intermediate-to-high risk localized prostate cancer.
The study achieved its primary endpoint by showing a significant improvement in disease-free survival. Additionally, Candel disclosed the commencement of a public offering with Citigroup (NYSE:C), BofA Securities, and Canaccord Genuity serving as joint bookrunning managers, and H.C. Wainwright & Co. acting as the lead manager.
The company also shared insights from a phase 2 clinical trial of CAN-2409 as a monotherapy in patients with low-to-intermediate risk localized prostate cancer.
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