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Gilead Sciences, Inc. (GILD - Free Report) recently announced that the FDA has accepted the supplemental biologics license application (sBLA) for the oncology drug Trodelvy (sacituzumab govitecan-hziy).
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.
The sBLA is seeking label expansion of Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
The regulatory body has granted Priority Review to the application, which is generally for therapies that, upon approval, would lead to significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to standard applications. The FDA has currently set a target action date for February 2023.
The sBLA is based on statistically significant and clinically meaningful overall survival and progression-free survival results from the phase III TROPiCS-02 Study.
A potential label expansion will boost the sales potential of the drug.
Trodelvy is approved in 35 countries with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The drug is also approved in the United States under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Gilead’s stock has lost 8.8% so far in the year compared with the industry's decline of 27.8%.
Image Source: Zacks Investment Research
Trodelvy is also being evaluated for use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including HR+/HER2- metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer and endometrial cancer.
With Trodelvy and its CAR T franchise, Gilead is making efforts to strengthen its oncology business to diversify its revenue base.
The breast cancer space is lucrative but saturated, and hence gaining market share will be tough.
Although the HIV business maintains momentum on the back of Biktarvy and the approval of new treatments, competition is stiff in the HIV business from the likes of GSK plc (GSK - Free Report) .
GSK’s HIV franchise recorded 7% growth in the second quarter. Growth was driven by new HIV products like Dovato, Cabenuva, Rukobia, Juluca and Apretude, and a favorable U.S. pricing mix.
Loss estimates for BOLT have narrowed to $2.31 from $2.87 in the past 90 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 90 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
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Gilead (GILD) Trodelvy Label Expansion sBLA Gets Priority Review
Gilead Sciences, Inc. (GILD - Free Report) recently announced that the FDA has accepted the supplemental biologics license application (sBLA) for the oncology drug Trodelvy (sacituzumab govitecan-hziy).
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.
The sBLA is seeking label expansion of Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
The regulatory body has granted Priority Review to the application, which is generally for therapies that, upon approval, would lead to significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to standard applications. The FDA has currently set a target action date for February 2023.
The sBLA is based on statistically significant and clinically meaningful overall survival and progression-free survival results from the phase III TROPiCS-02 Study.
A potential label expansion will boost the sales potential of the drug.
Trodelvy is approved in 35 countries with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The drug is also approved in the United States under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Gilead’s stock has lost 8.8% so far in the year compared with the industry's decline of 27.8%.
Image Source: Zacks Investment Research
Trodelvy is also being evaluated for use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including HR+/HER2- metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer and endometrial cancer.
With Trodelvy and its CAR T franchise, Gilead is making efforts to strengthen its oncology business to diversify its revenue base.
The breast cancer space is lucrative but saturated, and hence gaining market share will be tough.
Although the HIV business maintains momentum on the back of Biktarvy and the approval of new treatments, competition is stiff in the HIV business from the likes of GSK plc (GSK - Free Report) .
GSK’s HIV franchise recorded 7% growth in the second quarter. Growth was driven by new HIV products like Dovato, Cabenuva, Rukobia, Juluca and Apretude, and a favorable U.S. pricing mix.
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.31 from $2.87 in the past 90 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 90 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.