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Seagen's (SGEN) Late-Stage Cervical Cancer Study Meets Goals
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Seagen Inc. and partner Genmab A/S (GMAB - Free Report) together announced that the late-stage innovaTV 301 global study of Tivdak (tisotumab vedotin-tftv) in the treatment of recurrent or metastatic cervical cancer patients met its primary endpoint of overall survival (OS).
The phase III innovaTV 301 global study is evaluating the efficacy of Tivdak in comparison with chemotherapy alone. Per an independent data monitoring committee, the OS data from the interim analysis of the study crossed the pre-specified efficacy boundary at interim analysis.
The late-stage study also achieved its secondary endpoints of investigator-assessed progression-free survival and objective response rate, with statistical significance. Furthermore, the safety profile of Tivdak was found to be consistent with previously conducted studies with no new safety signals observed.
Seagen and Genmab are also planning to submit and discuss the study results with regulatory authorities.
Year to date, shares of Seagen have shot up 61.8% against the industry’s 11.9% fall.
Image Source: Zacks Investment Research
Tivdak received the FDA’s accelerated approval in September 2021 for the treatment of recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy. The accelerated approval was based on the positive results from the company’s innovaTV 204 study on Tivdak in the same indication.
Per SEGN and GMAB, the positive results from the phase III innovaTV 301 global study add to the results from the innovaTV 204 study on Tivdak. The companies expect the late-stage study on Tivdak to serve as the pivotal confirmatory study for the continued approval of the drug in the United States and support global regulatory applications, which are subject to discussions with respective regulatory authorities.
Tivdak is being co-developed and co-commercialized by Seagen and Genmab, sharing all costs and profits for the drug equally. In September 2022, SGEN also signed a licensing agreement with Zai Lab Limited (ZLAB - Free Report) , granting ZLAB the right to develop and commercialize Tivdak in mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Seagen is eligible to receive commercial milestone payments from Zai Lab and tiered royalty payments on net sales of Tivdak in Zai Lab territory.
Any such future payments received from Zai Lab will be shared equally with Genmab, per SGEN’s existing agreement with GMAB.
In the press release, Seagen also reported that it is continuing to enroll patients in an innovaTV 301 extension study of Tivdak in the cervical cancer indication, in China, in collaboration with Zai Lab.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 51 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of Dynavax have risen by 36.7%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
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Seagen's (SGEN) Late-Stage Cervical Cancer Study Meets Goals
Seagen Inc. and partner Genmab A/S (GMAB - Free Report) together announced that the late-stage innovaTV 301 global study of Tivdak (tisotumab vedotin-tftv) in the treatment of recurrent or metastatic cervical cancer patients met its primary endpoint of overall survival (OS).
The phase III innovaTV 301 global study is evaluating the efficacy of Tivdak in comparison with chemotherapy alone. Per an independent data monitoring committee, the OS data from the interim analysis of the study crossed the pre-specified efficacy boundary at interim analysis.
The late-stage study also achieved its secondary endpoints of investigator-assessed progression-free survival and objective response rate, with statistical significance. Furthermore, the safety profile of Tivdak was found to be consistent with previously conducted studies with no new safety signals observed.
Seagen and Genmab are also planning to submit and discuss the study results with regulatory authorities.
Year to date, shares of Seagen have shot up 61.8% against the industry’s 11.9% fall.
Image Source: Zacks Investment Research
Tivdak received the FDA’s accelerated approval in September 2021 for the treatment of recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy. The accelerated approval was based on the positive results from the company’s innovaTV 204 study on Tivdak in the same indication.
Per SEGN and GMAB, the positive results from the phase III innovaTV 301 global study add to the results from the innovaTV 204 study on Tivdak. The companies expect the late-stage study on Tivdak to serve as the pivotal confirmatory study for the continued approval of the drug in the United States and support global regulatory applications, which are subject to discussions with respective regulatory authorities.
Tivdak is being co-developed and co-commercialized by Seagen and Genmab, sharing all costs and profits for the drug equally. In September 2022, SGEN also signed a licensing agreement with Zai Lab Limited (ZLAB - Free Report) , granting ZLAB the right to develop and commercialize Tivdak in mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Seagen is eligible to receive commercial milestone payments from Zai Lab and tiered royalty payments on net sales of Tivdak in Zai Lab territory.
Any such future payments received from Zai Lab will be shared equally with Genmab, per SGEN’s existing agreement with GMAB.
In the press release, Seagen also reported that it is continuing to enroll patients in an innovaTV 301 extension study of Tivdak in the cervical cancer indication, in China, in collaboration with Zai Lab.
Seagen Inc. Price and Consensus
Seagen Inc. price-consensus-chart | Seagen Inc. Quote
Zacks Rank and Stock to Consider
Seagen currently has a Zacks Rank #4 (Sell).
A better-ranked stock from the same industry is Dynavax Technologies (DVAX - Free Report) , 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 Dynavax’s 2023 loss per share has narrowed from 51 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of Dynavax have risen by 36.7%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.