Candel Therapeutics Receives EMA Orphan Designation for CAN-2409 for the Treatment of Pancreatic Cancer
Candel Therapeutics' Regulatory Milestone: Candel Therapeutics announced that the European Medicines Agency has granted Orphan Designation for their investigational therapy CAN-2409 for pancreatic cancer, complementing existing FDA designations and highlighting the urgent need for effective treatments in this area.
Mechanism and Clinical Trial Results: CAN-2409 is designed to induce an immune response against tumors by delivering a gene that converts prodrugs into active agents, showing promising survival benefits in clinical trials, particularly for patients with borderline resectable pancreatic ductal adenocarcinoma.
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Candel Therapeutics to Hold Online R&D Event on December 5, 2025
Candel Therapeutics R&D Event: Candel Therapeutics will host a virtual Research and Development Day on December 5, 2025, featuring presentations and discussions on their viral immunotherapy approach and oncology pipeline, including insights from leading experts in the field.
Focus on CAN-2409 and CAN-3110: The event will highlight Candel's lead product candidates, CAN-2409 and CAN-3110, which are designed to treat various cancers through innovative immunotherapy methods, with promising results from ongoing clinical trials.
Regulatory Designations: CAN-2409 has received multiple regulatory designations from the FDA, including Fast Track and Orphan Drug Designations, indicating its potential in treating difficult-to-treat solid tumors like localized prostate cancer and non-small cell lung cancer.
Forward-Looking Statements: The company cautions that the information shared includes forward-looking statements that are subject to risks and uncertainties, which may affect the actual outcomes of their development programs and regulatory approvals.
Citigroup Upholds Buy Rating for Candel Therapeutics (CADL)
Analyst Recommendation: Citigroup has maintained a Buy recommendation for Candel Therapeutics, with a projected one-year price target of $19.38/share, indicating a potential upside of 316.33% from its current price of $4.66/share.
Fund Sentiment: There are 179 funds reporting positions in Candel Therapeutics, with a slight increase in ownership. The average portfolio weight for these funds is 0.07%, and the total shares owned by institutions decreased by 0.41% over the last three months.
Shareholder Activity: Notable shareholders include FBIOX, Acorn Capital Advisors, and IWM, with varying changes in their holdings. Acorn Capital Advisors increased its stake by 16.60%, while Portolan Capital Management decreased its holdings by 17.16%.
Market Outlook: The put/call ratio for Candel Therapeutics is 0.33, suggesting a bullish outlook among investors, while the projected annual revenue is expected to rise significantly by 79,854.84%.
Candel Halts Development of CAN-2409 for Prostate Cancer
Development Pause: Candel Therapeutics is pausing the development of CAN-2409 for borderline resectable pancreatic adenocarcinoma to focus on localized, intermediate/high risk pancreatic cancer and non-small cell lung cancer (NSCLC).
Clinical Trials Update: The company is preparing for a Biologics License Application (BLA) submission for CAN-2409 in localized pancreatic cancer and plans to initiate a phase 3 study in NSCLC by Q2 2026.
Financial Performance: Candel's Q3 financial results fell short of expectations, indicating challenges in their financial performance.
Market Reactions: The stock prices of Candel and other biopharma companies like Erasca and Xencor have declined following a downgrade by BofA due to a perceived lack of near-term catalysts.
Candel Therapeutics Announces Financial Results for Q3 2025 and Key Corporate Updates
Clinical Trial Updates: Candel Therapeutics presented new data from its phase 3 trial of CAN-2409 for localized prostate cancer, showing improved disease-free survival, and plans to initiate a pivotal phase 3 trial for CAN-2409 in metastatic non-small cell lung cancer (NSCLC) in Q2 2026.
Survival Data for CAN-3110: The company reported encouraging survival data from its phase 1b trial of CAN-3110 in recurrent high-grade glioma, with plans for a randomized phase 2 trial based on the findings.
Financial Developments: Candel secured a $130 million term loan facility to strengthen its financial position, allowing for the advancement of its clinical programs, including the upcoming trials for CAN-2409.
Future Milestones: Key upcoming milestones include the submission of a Biologics License Application for CAN-2409 in prostate cancer by Q4 2026 and updated survival data from ongoing trials expected in early to mid-2026.
Candel Therapeutics to Showcase at Jefferies Global Healthcare Conference in London
Company Presentation: Candel Therapeutics will present at the Jefferies Global Healthcare Conference in London on November 18, 2025, with a webcast available for those interested.
Product Development: Candel is focused on developing multimodal viral immunotherapies, with its lead product candidate CAN-2409 recently completing successful phase 2a trials for non-small cell lung cancer and pancreatic cancer.
Regulatory Designations: CAN-2409 has received multiple designations from the FDA, including Fast Track, Regenerative Medicine Advanced Therapy, and Orphan Drug Designation for various cancer treatments.
Ongoing Trials: The company is also advancing its HSV platform with CAN-3110, currently in a phase 1b trial for recurrent high-grade glioma, and has published initial results in prominent scientific journals.
LifeSci Capital Begins Coverage of Candel Therapeutics with Outperform Rating and Sets Price Target at $16
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders, helping them stay informed and make timely decisions in the stock market.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters, enhancing the trading experience for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, fostering a collaborative environment for sharing market intelligence.
Market Winning Tools: Benzinga Pro equips traders with tools and information necessary to succeed in the markets every day.
Candel Therapeutics to Hold Online R&D Event on December 5, 2025
Candel Therapeutics R&D Event: Candel Therapeutics will host a virtual Research and Development Day on December 5, 2025, featuring presentations and discussions on their viral immunotherapy approach and oncology pipeline, including insights from leading experts in the field.
Focus on CAN-2409 and CAN-3110: The event will highlight Candel's lead product candidates, CAN-2409 and CAN-3110, which are designed to treat various cancers through innovative immunotherapy methods, with promising results from ongoing clinical trials.
Regulatory Designations: CAN-2409 has received multiple regulatory designations from the FDA, including Fast Track and Orphan Drug Designations, indicating its potential in treating difficult-to-treat solid tumors like localized prostate cancer and non-small cell lung cancer.
Forward-Looking Statements: The company cautions that the information shared includes forward-looking statements that are subject to risks and uncertainties, which may affect the actual outcomes of their development programs and regulatory approvals.
Citigroup Upholds Buy Rating for Candel Therapeutics (CADL)
Analyst Recommendation: Citigroup has maintained a Buy recommendation for Candel Therapeutics, with a projected one-year price target of $19.38/share, indicating a potential upside of 316.33% from its current price of $4.66/share.
Fund Sentiment: There are 179 funds reporting positions in Candel Therapeutics, with a slight increase in ownership. The average portfolio weight for these funds is 0.07%, and the total shares owned by institutions decreased by 0.41% over the last three months.
Shareholder Activity: Notable shareholders include FBIOX, Acorn Capital Advisors, and IWM, with varying changes in their holdings. Acorn Capital Advisors increased its stake by 16.60%, while Portolan Capital Management decreased its holdings by 17.16%.
Market Outlook: The put/call ratio for Candel Therapeutics is 0.33, suggesting a bullish outlook among investors, while the projected annual revenue is expected to rise significantly by 79,854.84%.
Candel Halts Development of CAN-2409 for Prostate Cancer
Development Pause: Candel Therapeutics is pausing the development of CAN-2409 for borderline resectable pancreatic adenocarcinoma to focus on localized, intermediate/high risk pancreatic cancer and non-small cell lung cancer (NSCLC).
Clinical Trials Update: The company is preparing for a Biologics License Application (BLA) submission for CAN-2409 in localized pancreatic cancer and plans to initiate a phase 3 study in NSCLC by Q2 2026.
Financial Performance: Candel's Q3 financial results fell short of expectations, indicating challenges in their financial performance.
Market Reactions: The stock prices of Candel and other biopharma companies like Erasca and Xencor have declined following a downgrade by BofA due to a perceived lack of near-term catalysts.
Candel Therapeutics Announces Financial Results for Q3 2025 and Key Corporate Updates
Clinical Trial Updates: Candel Therapeutics presented new data from its phase 3 trial of CAN-2409 for localized prostate cancer, showing improved disease-free survival, and plans to initiate a pivotal phase 3 trial for CAN-2409 in metastatic non-small cell lung cancer (NSCLC) in Q2 2026.
Survival Data for CAN-3110: The company reported encouraging survival data from its phase 1b trial of CAN-3110 in recurrent high-grade glioma, with plans for a randomized phase 2 trial based on the findings.
Financial Developments: Candel secured a $130 million term loan facility to strengthen its financial position, allowing for the advancement of its clinical programs, including the upcoming trials for CAN-2409.
Future Milestones: Key upcoming milestones include the submission of a Biologics License Application for CAN-2409 in prostate cancer by Q4 2026 and updated survival data from ongoing trials expected in early to mid-2026.
Candel Therapeutics to Showcase at Jefferies Global Healthcare Conference in London
Company Presentation: Candel Therapeutics will present at the Jefferies Global Healthcare Conference in London on November 18, 2025, with a webcast available for those interested.
Product Development: Candel is focused on developing multimodal viral immunotherapies, with its lead product candidate CAN-2409 recently completing successful phase 2a trials for non-small cell lung cancer and pancreatic cancer.
Regulatory Designations: CAN-2409 has received multiple designations from the FDA, including Fast Track, Regenerative Medicine Advanced Therapy, and Orphan Drug Designation for various cancer treatments.
Ongoing Trials: The company is also advancing its HSV platform with CAN-3110, currently in a phase 1b trial for recurrent high-grade glioma, and has published initial results in prominent scientific journals.
LifeSci Capital Begins Coverage of Candel Therapeutics with Outperform Rating and Sets Price Target at $16
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders, helping them stay informed and make timely decisions in the stock market.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters, enhancing the trading experience for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, fostering a collaborative environment for sharing market intelligence.
Market Winning Tools: Benzinga Pro equips traders with tools and information necessary to succeed in the markets every day.
