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Day One (DAWN) In-Licenses MabCare Cancer Candidate, Stock Up
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Day One Biopharmaceuticals (DAWN - Free Report) signed an exclusive licensing agreement with MabCare Therapeutics for exclusive worldwide rights to develop, manufacture and commercialize the latter’s investigational candidate, MTX-13 (now DAY301), for solid tumor indications. Shares of the company gained 11.3% on Jun 18, in response to the encouraging news.
The addition of this antibody-drug conjugate (ADC) will expand Day One’s clinical-stage oncology pipeline. DAY301 targets PTK7, a transmembrane protein that is highly expressed in a broad range of adult cancers, including esophageal, ovarian, lung and endometrial cancer, as well as in pediatric cancers, such as neuroblastoma, rhabdomyosarcoma and osteosarcoma.
Per Day One, PTK7 has limited expression in normal tissues or organs, making it an attractive target for therapeutic development.
It is important to note that the investigational new drug application for DAY301 received FDA clearance in April 2024 based on positive results from its pre-clinical studies, where the candidate showed antitumor activity in a wide range of solid tumors. Day One aims to dose the first patient in the phase I study of DAY301 to treat solid tumors by late 2024 or early 2025.
Day One believes that the linker-payload technology in DAY301 will surpass the limitations of previous PTK7-targeted ADCs, positioning DAY301 as a potential first-in-class drug against a clinically validated target. DAWN plans to begin clinical studies in the coming months.
Year to date, shares of Day One have lost 8.3% compared with the industry’s 7.1% decline.
Image Source: Zacks Investment Research
Per the terms of the licensing agreement, DAWN is liable to make an upfront payment of $55 million to MabCare for the worldwide rights to DAY301, excluding Greater China. Moreover, Day One remains liable to pay an additional $1.152 billion of potential milestone payments to MabCare, plus royalties on net sales outside of Greater China, if the product gets approval.
Please note that in April 2024, Day One received the FDA’s accelerated approval for its lead candidate, tovorafenib, under the brand name, Ojemda, to treat pediatric patients aged six months and older with relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG). Ojemda, a type II RAF inhibitor, is also the first product in Day One’s commercial portfolio.
Ojemda is currently the only systemic therapy for pLGG in the United States that offers once-weekly dosing, with or without food, as a tablet or oral suspension. The company has already commenced the drug's commercial launch in the region. The initial sales figures of Ojemda are expected to be announced in the second-quarter earnings release.
Day One is also evaluating Ojemda in a pivotal late-stage study as a front-line therapy in patients aged six months to 25 years with pLGG. The potential success of the study will further expand the eligible patient population for treatment with the drug, subject to approval. The phase III front-line pLGG study is currently enrolling patients.
The company’s clinical-stage pipeline comprises another investigational candidate, pimasertib, a MEK 1/2 inhibitor, which is being evaluated in an early-stage study in combination with tovorafenib to treat MAPK-altered solid tumors.
Day One Biopharmaceuticals, Inc. Price and Consensus
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 53.5%.
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 plunged 71.6%.
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 increased from 2 cents to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 6.1%.
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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Day One (DAWN) In-Licenses MabCare Cancer Candidate, Stock Up
Day One Biopharmaceuticals (DAWN - Free Report) signed an exclusive licensing agreement with MabCare Therapeutics for exclusive worldwide rights to develop, manufacture and commercialize the latter’s investigational candidate, MTX-13 (now DAY301), for solid tumor indications. Shares of the company gained 11.3% on Jun 18, in response to the encouraging news.
The addition of this antibody-drug conjugate (ADC) will expand Day One’s clinical-stage oncology pipeline. DAY301 targets PTK7, a transmembrane protein that is highly expressed in a broad range of adult cancers, including esophageal, ovarian, lung and endometrial cancer, as well as in pediatric cancers, such as neuroblastoma, rhabdomyosarcoma and osteosarcoma.
Per Day One, PTK7 has limited expression in normal tissues or organs, making it an attractive target for therapeutic development.
It is important to note that the investigational new drug application for DAY301 received FDA clearance in April 2024 based on positive results from its pre-clinical studies, where the candidate showed antitumor activity in a wide range of solid tumors. Day One aims to dose the first patient in the phase I study of DAY301 to treat solid tumors by late 2024 or early 2025.
Day One believes that the linker-payload technology in DAY301 will surpass the limitations of previous PTK7-targeted ADCs, positioning DAY301 as a potential first-in-class drug against a clinically validated target. DAWN plans to begin clinical studies in the coming months.
Year to date, shares of Day One have lost 8.3% compared with the industry’s 7.1% decline.
Image Source: Zacks Investment Research
Per the terms of the licensing agreement, DAWN is liable to make an upfront payment of $55 million to MabCare for the worldwide rights to DAY301, excluding Greater China. Moreover, Day One remains liable to pay an additional $1.152 billion of potential milestone payments to MabCare, plus royalties on net sales outside of Greater China, if the product gets approval.
Please note that in April 2024, Day One received the FDA’s accelerated approval for its lead candidate, tovorafenib, under the brand name, Ojemda, to treat pediatric patients aged six months and older with relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG). Ojemda, a type II RAF inhibitor, is also the first product in Day One’s commercial portfolio.
Ojemda is currently the only systemic therapy for pLGG in the United States that offers once-weekly dosing, with or without food, as a tablet or oral suspension. The company has already commenced the drug's commercial launch in the region. The initial sales figures of Ojemda are expected to be announced in the second-quarter earnings release.
Day One is also evaluating Ojemda in a pivotal late-stage study as a front-line therapy in patients aged six months to 25 years with pLGG. The potential success of the study will further expand the eligible patient population for treatment with the drug, subject to approval. The phase III front-line pLGG study is currently enrolling patients.
The company’s clinical-stage pipeline comprises another investigational candidate, pimasertib, a MEK 1/2 inhibitor, which is being evaluated in an early-stage study in combination with tovorafenib to treat MAPK-altered solid tumors.
Day One Biopharmaceuticals, Inc. Price and Consensus
Day One Biopharmaceuticals, Inc. price-consensus-chart | Day One Biopharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Day One currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings (ALXO - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. 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 53.5%.
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 plunged 71.6%.
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 increased from 2 cents to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 6.1%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.