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Investing.com - H.C. Wainwright has initiated coverage on Candel Therapeutics Inc. (NASDAQ:CADL) with a Buy rating and a price target of $23.00, highlighting the company’s lead immunotherapy candidate for prostate cancer. Trading at $4.90, the stock sits well below analyst targets ranging from $15 to $25. According to InvestingPro data, CADL maintains a strong financial position with more cash than debt on its balance sheet.
The firm’s analysis focuses on CAN-2409, an off-the-shelf, multimodal immunotherapy designed to destroy tumor cells locally while triggering systemic T-cell responses. Phase 3 data for the treatment showed a 30% reduction in disease recurrence or death and a 38% improvement in prostate-specific disease-free survival in patients with localized intermediate/high-risk prostate cancer. With a market capitalization of $245.5 million and a "Fair" overall financial health score from InvestingPro, the company shows promising development potential despite current unprofitability.
The 745-patient randomized trial was conducted under an FDA Special Protocol Assessment, which H.C. Wainwright notes enhances regulatory confidence ahead of the planned Biologics License Application submission in Q4 2026. CAN-2409 has received both Regenerative Medicine Advanced Therapy designation and Fast Track status from the FDA.
H.C. Wainwright points to the treatment’s administration advantages, requiring only three ultrasound-guided intraprostatic injections spaced 2-6 weeks apart during a 20-minute outpatient procedure, alongside short-course valacyclovir. The therapy demonstrated favorable tolerability with lower rates of serious adverse events and treatment discontinuations compared to placebo.
The firm identifies a potential $10 billion-plus U.S. market opportunity in localized prostate cancer, with emerging payor support driven by the drug’s potential to delay or avoid long-term androgen deprivation therapy, which presents significant cost and quality-of-life challenges for patients. CADL’s strong liquidity position, evidenced by a current ratio of 4.64, suggests adequate resources to pursue this substantial market opportunity. Unlock more insights and 6 additional ProTips with InvestingPro.
In other recent news, Candel Therapeutics announced a $15 million capital raise through a registered direct offering, selling approximately 3.2 million shares to accredited investors. The proceeds are earmarked for pre-commercialization and launch readiness activities for CAN-2409, their lead product candidate for prostate cancer, pending regulatory approval. Additionally, Candel Therapeutics has appointed Charles Schoch as its permanent Chief Financial Officer, following his interim tenure that included a significant capital raise of approximately $86 million. The company also named Maha Radhakrishnan, M.D., to its Board of Directors to aid in strategic initiatives as it prepares for a Biologics License Application submission for CAN-2409.
The U.S. FDA granted CAN-2409 Regenerative Medicine Advanced Therapy (RMAT) designation for treating newly diagnosed localized prostate cancer, expediting its development and review process. This follows a successful phase 3 clinical trial that showed a 30% reduction in the risk of prostate cancer recurrence or death, meeting primary and secondary endpoints. The trial results, which will be presented at the American Society of Clinical Oncology Annual Meeting, also demonstrated a higher pathological clinical response rate in two-year biopsies. Candel Therapeutics is advancing regulatory preparations for a Biologics License Application, aiming to address unmet needs in prostate cancer treatment.
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