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Adicet (ACET) Up as Kidney Cancer Drug Gets FDA's Fast Track Tag
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Adicet Bio (ACET - Free Report) gained 9.4% on Jul 8 and continued to gain another 2.6% during the after-market hours after the FDA granted Fast Track designation to its investigational candidate, ADI-270, for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC). ccRCC is a form of kidney cancer.
The eligible patient population for the candidate includes ccRCC patients who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.
ADI-270 is Adicet’s allogeneic gamma delta CAR T cell therapy targeting CD70 protein, which is highly expressed in both solid and hematologic malignancies. Apart from the RCC indication, the company also plans later to study the candidate for other solid tumor indications.
The FDA’s Fast Track designation intends to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions.
The Fast Track tag enables close communication between the FDA and sponsor to improve the efficiency of product development to get new therapeutics for patients faster. It also makes innovative therapies eligible for potential accelerated approval and priority review if relevant criteria are met.
Year to date, shares of ACET have plunged 38.1% compared with the industry’s 7.9% decline.
Image Source: Zacks Investment Research
Please note that in June 2024, the FDA cleared Adicet’s investigational new drug (IND) application to evaluate ADI-270 for the treatment ofrelapsed/refractory RCC patients. The company is currently gearing up to initiate a phase I study to assess ADI-270 as a monotherapy in adults with relapsed or refractory ccRCC in the second half of 2024.
The study includes dose escalation and dose expansion phases, assessing safety, tolerability, and pharmacokinetics. Additionally, it will evaluate the anti-tumor activity of ADI-270 by measuring overall response rate, duration of response, and disease control rate.
In the first quarter of 2024 SEC filing, Adicet stated that it expects to share clinical data from the phase I ccRCC study in the first half of 2025. The company further anticipates potential expansion into additional CD70+ tumor indications in the first half of 2025, with possible clinical data from such studies in the second half of 2025.
Adicet’s clinical-stage pipeline also comprises its lead product candidate, ADI-001, a first-in-class allogeneic gamma delta T cell therapy expressing a CAR targeting CD20 protein. It is currently being evaluated in an early-stage study for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma.
Additionally, the company is also preparing to initiate soon a phase I study to assess the safety and efficacy of ADI-001 in lupus nephritis, following IND clearance in December 2023. A clinical update from the lupus nephritis study is expected during the fourth quarter of 2024 or the first quarter of 2025, depending on patient enrollment and study site activation. Furthermore, ACET intends to expand the ADI-001 development program into additional autoimmune indications.
It is important to note that Adicet’s lead candidate also enjoys the FDA’s Fast Track designation for the lupus nephritis indication.
In the first quarter of 2024 earnings release, the company reported having cash, cash equivalents and short-term investments worth $247.6 million, which it expects to be sufficient to fund operations into the second half of 2026. This indicates that the company enjoys a favorable cash position.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 62.1%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have lost 17.3%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 13.6%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
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Adicet (ACET) Up as Kidney Cancer Drug Gets FDA's Fast Track Tag
Adicet Bio (ACET - Free Report) gained 9.4% on Jul 8 and continued to gain another 2.6% during the after-market hours after the FDA granted Fast Track designation to its investigational candidate, ADI-270, for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC). ccRCC is a form of kidney cancer.
The eligible patient population for the candidate includes ccRCC patients who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.
ADI-270 is Adicet’s allogeneic gamma delta CAR T cell therapy targeting CD70 protein, which is highly expressed in both solid and hematologic malignancies. Apart from the RCC indication, the company also plans later to study the candidate for other solid tumor indications.
The FDA’s Fast Track designation intends to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions.
The Fast Track tag enables close communication between the FDA and sponsor to improve the efficiency of product development to get new therapeutics for patients faster. It also makes innovative therapies eligible for potential accelerated approval and priority review if relevant criteria are met.
Year to date, shares of ACET have plunged 38.1% compared with the industry’s 7.9% decline.
Image Source: Zacks Investment Research
Please note that in June 2024, the FDA cleared Adicet’s investigational new drug (IND) application to evaluate ADI-270 for the treatment ofrelapsed/refractory RCC patients. The company is currently gearing up to initiate a phase I study to assess ADI-270 as a monotherapy in adults with relapsed or refractory ccRCC in the second half of 2024.
The study includes dose escalation and dose expansion phases, assessing safety, tolerability, and pharmacokinetics. Additionally, it will evaluate the anti-tumor activity of ADI-270 by measuring overall response rate, duration of response, and disease control rate.
In the first quarter of 2024 SEC filing, Adicet stated that it expects to share clinical data from the phase I ccRCC study in the first half of 2025. The company further anticipates potential expansion into additional CD70+ tumor indications in the first half of 2025, with possible clinical data from such studies in the second half of 2025.
Adicet’s clinical-stage pipeline also comprises its lead product candidate, ADI-001, a first-in-class allogeneic gamma delta T cell therapy expressing a CAR targeting CD20 protein. It is currently being evaluated in an early-stage study for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma.
Additionally, the company is also preparing to initiate soon a phase I study to assess the safety and efficacy of ADI-001 in lupus nephritis, following IND clearance in December 2023. A clinical update from the lupus nephritis study is expected during the fourth quarter of 2024 or the first quarter of 2025, depending on patient enrollment and study site activation. Furthermore, ACET intends to expand the ADI-001 development program into additional autoimmune indications.
It is important to note that Adicet’s lead candidate also enjoys the FDA’s Fast Track designation for the lupus nephritis indication.
In the first quarter of 2024 earnings release, the company reported having cash, cash equivalents and short-term investments worth $247.6 million, which it expects to be sufficient to fund operations into the second half of 2026. This indicates that the company enjoys a favorable cash position.
Adicet Bio, Inc. Price and Consensus
Adicet Bio, Inc. price-consensus-chart | Adicet Bio, Inc. Quote
Zacks Rank and Stocks to Consider
Adicet currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industryare ALX Oncology Holdings (ALXO - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) . Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 62.1%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have lost 17.3%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 13.6%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.