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Candel (CADL) Up as Pancreatic Cancer Drug Gets Orphan Drug Tag
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Candel Therapeutics, Inc. (CADL - Free Report) announced that the FDA has granted orphan drug designation to its lead investigational adenovirus immunotherapy candidate, CAN-2409, for the treatment of pancreatic ductal adenocarcinoma (PDAC). Shares of the company rallied 42.8% on Apr 12, following the news.
The FDA grants the orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 patients in the United States. The orphan drug designation will grant Candel market exclusivity for CAN-2409 in the treatment of PDAC for a predefined time period, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval.
Per management, the orphan designation grant reaffirms the potential of Candel’s CAN-2409 to treat rare and difficult-to-treat forms of cancer. Please note that last year, the FDA also granted the Fast Track designation to CAN-2409 for the same indication.
The Fast Track designation facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
Year to date, shares of Candel have skyrocketed 395.2% against the industry’s 6% decline.
Image Source: Zacks Investment Research
We remind the investors that earlier this month, CADL reported positive interim data from the phase II study evaluating CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable PDAC.
The updated interim data from the ongoing mid-stage study showed that experimental treatment with CAN-2409 led to notable improvements (more than doubled) in the estimated median overall survival of 28.8 months compared with only 12.5 months in the control group in the PDAC patient population.
If successfully developed, followed by a potential approval for CAN-2409, it could present a significant commercial opportunity for Candel. There is a high unmet medical need for effective new treatments, given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC.
Apart from pancreatic cancer, CADL expects key data readouts for CAN-2409 in non-small cell lung cancer later in the second quarter of 2024, while top-line data in prostate cancer is expected in the fourth quarter of 2024.
In the absence of a marketed product, the successful development of its pipeline candidates remains the key focus for this clinical-stage biopharmaceutical company.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 37.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have rallied 53.4%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 34.8%.
ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
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Candel (CADL) Up as Pancreatic Cancer Drug Gets Orphan Drug Tag
Candel Therapeutics, Inc. (CADL - Free Report) announced that the FDA has granted orphan drug designation to its lead investigational adenovirus immunotherapy candidate, CAN-2409, for the treatment of pancreatic ductal adenocarcinoma (PDAC). Shares of the company rallied 42.8% on Apr 12, following the news.
The FDA grants the orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 patients in the United States. The orphan drug designation will grant Candel market exclusivity for CAN-2409 in the treatment of PDAC for a predefined time period, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval.
Per management, the orphan designation grant reaffirms the potential of Candel’s CAN-2409 to treat rare and difficult-to-treat forms of cancer. Please note that last year, the FDA also granted the Fast Track designation to CAN-2409 for the same indication.
The Fast Track designation facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
Year to date, shares of Candel have skyrocketed 395.2% against the industry’s 6% decline.
Image Source: Zacks Investment Research
We remind the investors that earlier this month, CADL reported positive interim data from the phase II study evaluating CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable PDAC.
The updated interim data from the ongoing mid-stage study showed that experimental treatment with CAN-2409 led to notable improvements (more than doubled) in the estimated median overall survival of 28.8 months compared with only 12.5 months in the control group in the PDAC patient population.
If successfully developed, followed by a potential approval for CAN-2409, it could present a significant commercial opportunity for Candel. There is a high unmet medical need for effective new treatments, given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC.
Apart from pancreatic cancer, CADL expects key data readouts for CAN-2409 in non-small cell lung cancer later in the second quarter of 2024, while top-line data in prostate cancer is expected in the fourth quarter of 2024.
In the absence of a marketed product, the successful development of its pipeline candidates remains the key focus for this clinical-stage biopharmaceutical company.
Candel Therapeutics, Inc. Price and Consensus
Candel Therapeutics, Inc. price-consensus-chart | Candel Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Candel currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Annovis Bio (ANVS - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ANVS carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 37.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have rallied 53.4%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 34.8%.
ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.