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Seagen (SGEN) Completes Enrollment in Colorectal Cancer Study
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Seagen Inc. announced that it has completed patient enrollment in the phase II MOUNTAINEER study evaluating its marketed drug, Tukysa (tucatinib), a tyrosine kinase inhibitor (“TKI”).
The company has completed enrollment in the mid-stage study evaluating Tukysa in combination with Roche’s (RHHBY - Free Report) Herceptin (trastuzumab) and as a single agent for treating patients with HER2-positive metastatic colorectal cancer (mCRC) who were previously treated with first- and second-line standard-of-care therapies.
The primary endpoint of the study is to check objective response rate by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 criteria. The secondary objectives include duration of response, progression-free survival, overall survival, and safety and tolerability of the combination regimen.
The multi-center, open-label phase II MOUNTAINEER study is designed to support registration for Tukysa under accelerated approval regulations in the United States.
Shares of Seagen have declined 7.9% so far this year compared with the industry’s decrease of 2.6%.
Image Source: Zacks Investment Research
We remind investors that in April 2020, the FDA approved Tukysa in combination with Roche's Herceptin and Xeloda (capecitabine) to treat adult patients with locally advanced/metastatic HER2-positive breast cancer, including those with brain metastases, having received one or more prior anti-HER2-based regimens in the metastatic setting. In February 2021, the European Commission granted marketing authorization to the Tukysa combo for the given indication.
In the first six months of 2021, Tukysa generated sales worth $153.3 million, reflecting a significant year-over-year increase.
Seagen’s portfolio primarily comprises of three marketed drugs, namely, Adcetris, Padcev and Tukysa, which are approved for different cancer indications. The company generated net product revenues of $649.9 million in the first six months of 2021, reflecting 48% growth year over year.
Earlier this month, the FDA granted accelerated approval to Tivdak (tisotumab vedotin-tftv) for the treatment of recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy. The drug is being developed in collaboration with Denmark’s Genmab A/S (GMAB - Free Report) .
The approval for Tivdak has now added a fourth drug to Seagen’s portfolio, which should drive growth for the company in 2021 and beyond.
Image: Bigstock
Seagen (SGEN) Completes Enrollment in Colorectal Cancer Study
Seagen Inc. announced that it has completed patient enrollment in the phase II MOUNTAINEER study evaluating its marketed drug, Tukysa (tucatinib), a tyrosine kinase inhibitor (“TKI”).
The company has completed enrollment in the mid-stage study evaluating Tukysa in combination with Roche’s (RHHBY - Free Report) Herceptin (trastuzumab) and as a single agent for treating patients with HER2-positive metastatic colorectal cancer (mCRC) who were previously treated with first- and second-line standard-of-care therapies.
The primary endpoint of the study is to check objective response rate by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 criteria. The secondary objectives include duration of response, progression-free survival, overall survival, and safety and tolerability of the combination regimen.
The multi-center, open-label phase II MOUNTAINEER study is designed to support registration for Tukysa under accelerated approval regulations in the United States.
Shares of Seagen have declined 7.9% so far this year compared with the industry’s decrease of 2.6%.
We remind investors that in April 2020, the FDA approved Tukysa in combination with Roche's Herceptin and Xeloda (capecitabine) to treat adult patients with locally advanced/metastatic HER2-positive breast cancer, including those with brain metastases, having received one or more prior anti-HER2-based regimens in the metastatic setting. In February 2021, the European Commission granted marketing authorization to the Tukysa combo for the given indication.
In the first six months of 2021, Tukysa generated sales worth $153.3 million, reflecting a significant year-over-year increase.
Seagen’s portfolio primarily comprises of three marketed drugs, namely, Adcetris, Padcev and Tukysa, which are approved for different cancer indications. The company generated net product revenues of $649.9 million in the first six months of 2021, reflecting 48% growth year over year.
Earlier this month, the FDA granted accelerated approval to Tivdak (tisotumab vedotin-tftv) for the treatment of recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy. The drug is being developed in collaboration with Denmark’s Genmab A/S (GMAB - Free Report) .
The approval for Tivdak has now added a fourth drug to Seagen’s portfolio, which should drive growth for the company in 2021 and beyond.
Zacks Rank & Stock to Consider
Seagen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex’s earnings estimates have been revised 2.4% upward for 2021 and 3.1% upward for 2022 over the past 60 days.