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Exelixis (EXEL) Outperforms on Cabometyx and Pipeline Progress
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Exelixis (EXEL - Free Report) has been a consistent outperformer and maintains a solid performance.
Its lead drug, Cabometyx, maintained its status as the leading tyrosine kinase inhibitor (“TKI”) for the treatment of renal cell carcinoma (“RCC”) in 2023. This was mainly attributable to its use in combination with Bristol Myers’ (BMY - Free Report) Opdivo in the first-line setting. The drug also maintained growth in the hepatocellular carcinoma indication.
BMY’s Opdivo is one of the leading immuno-oncology drugs and is approved for various oncology indications.
Shares of EXEL gained 16.8% in the past six months compared with the industry’s growth of 0.9%.
Image Source: Zacks Investment Research
Earlier this month, management outlined pipeline plans for 2024 and released preliminary results.
Management will focus on the label expansion of its lead drug Cabometyx in 2024, accelerate the development of zanzalintinib, XB002 and XL309 and advance three other promising preclinical programs into clinical development.
Exelixis is evaluating the combination of cabozantinib and Tecentriq (atezolizumab) versus a second novel hormonal therapy (“NHT”) in patients with metastatic castration-resistant prostate cancer (“mCRPC”) and measurable extrapelvic soft tissue disease who have been previously treated with one NHT. The company will continue its discussions with the FDA on a potential regulatory path forward for cabozantinib in mCRPC.
A potential regulatory filing for cabozantinib in advanced neuroendocrine tumors (“NET”) based on positive results from the pivotal phase III CABINET study, which evaluates cabozantinib versus placebo in patients with either advanced pancreatic NET or extra-pancreatic NET, is also targeted in 2024.
Zanzalintinib, a third-generation TKI, is being evaluated in three ongoing pivotal trials, STELLAR-303, -304 and -305, in forms of colorectal cancer, non-clear cell RCC and squamous cell carcinoma of the head and neck (SCCHN), respectively.
In December 2023, EXEL initiated STELLAR-305, a phase II/III study evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic SCCHN.
Exelixis has also collaborated with Arcus Biosciences (RCUS - Free Report) to evaluate zanzalintinib in combination with AB521 in patients with advanced RCC.
While Exelixis is sponsoring the study, Arcus is co-funding it and providing AB521 for use.
The oncology-focused company is looking to build a portfolio beyond Cabometyx.
XB002 is a next-generation tissue factor-targeting antibody-drug conjugate (“ADC”) that is being evaluated as a monotherapy and in combination regimens. This year, Exelixis is focused on advancing JEWEL-101, the phase I study of XB002 alone and in combination with immunotherapy in a variety of solid tumor settings, with the goal of prioritizing sensitive tumor types for full development.
XL309, a potentially best-in-class small-molecule inhibitor of USP1, has emerged as a synthetic lethal target in the context of BRCA-mutated tumors. Exelixis’ clinical development priorities for XL309 include accelerating its development as a potential therapy for tumors that have become refractory to PARP inhibitor (“PARPi”) therapy, including forms of ovarian, breast and prostate cancers, pursuing potential PARPi combinations and moving beyond the PARPi market into new areas.
Concurrently, the company will implement a corporate restructuring to prioritize the advancement of its most promising programs. As a result, EXEL will reduce its headcount by approximately 175 employees or 13%.
Separately, its board of directors authorized the repurchase of up to an additional $450 million of the company’s common stock in 2024.
EXEL plans to file an investigational new drug (“IND”) application for the XB010 5T4-MMAE ADC program in the first half of 2024 and expects to file IND applications for the XB628 PD-L1-NKG2A bispecific antibody and XL495 small molecule PKMYT1 inhibitor programs in the second half of 2024 if preclinical data continues to remain supportive.
The strong performance of Cabometyx and encouraging pipeline progress should help Exelixis maintain its solid growth trajectory.
In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.66 per share. REGN’s stock has gained 28.5% in the past year. The company beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.
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Exelixis (EXEL) Outperforms on Cabometyx and Pipeline Progress
Exelixis (EXEL - Free Report) has been a consistent outperformer and maintains a solid performance.
Its lead drug, Cabometyx, maintained its status as the leading tyrosine kinase inhibitor (“TKI”) for the treatment of renal cell carcinoma (“RCC”) in 2023. This was mainly attributable to its use in combination with Bristol Myers’ (BMY - Free Report) Opdivo in the first-line setting. The drug also maintained growth in the hepatocellular carcinoma indication.
BMY’s Opdivo is one of the leading immuno-oncology drugs and is approved for various oncology indications.
Shares of EXEL gained 16.8% in the past six months compared with the industry’s growth of 0.9%.
Image Source: Zacks Investment Research
Earlier this month, management outlined pipeline plans for 2024 and released preliminary results.
Management will focus on the label expansion of its lead drug Cabometyx in 2024, accelerate the development of zanzalintinib, XB002 and XL309 and advance three other promising preclinical programs into clinical development.
Exelixis is evaluating the combination of cabozantinib and Tecentriq (atezolizumab) versus a second novel hormonal therapy (“NHT”) in patients with metastatic castration-resistant prostate cancer (“mCRPC”) and measurable extrapelvic soft tissue disease who have been previously treated with one NHT. The company will continue its discussions with the FDA on a potential regulatory path forward for cabozantinib in mCRPC.
A potential regulatory filing for cabozantinib in advanced neuroendocrine tumors (“NET”) based on positive results from the pivotal phase III CABINET study, which evaluates cabozantinib versus placebo in patients with either advanced pancreatic NET or extra-pancreatic NET, is also targeted in 2024.
Zanzalintinib, a third-generation TKI, is being evaluated in three ongoing pivotal trials, STELLAR-303, -304 and -305, in forms of colorectal cancer, non-clear cell RCC and squamous cell carcinoma of the head and neck (SCCHN), respectively.
In December 2023, EXEL initiated STELLAR-305, a phase II/III study evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic SCCHN.
Exelixis has also collaborated with Arcus Biosciences (RCUS - Free Report) to evaluate zanzalintinib in combination with AB521 in patients with advanced RCC.
While Exelixis is sponsoring the study, Arcus is co-funding it and providing AB521 for use.
The oncology-focused company is looking to build a portfolio beyond Cabometyx.
XB002 is a next-generation tissue factor-targeting antibody-drug conjugate (“ADC”) that is being evaluated as a monotherapy and in combination regimens. This year, Exelixis is focused on advancing JEWEL-101, the phase I study of XB002 alone and in combination with immunotherapy in a variety of solid tumor settings, with the goal of prioritizing sensitive tumor types for full development.
XL309, a potentially best-in-class small-molecule inhibitor of USP1, has emerged as a synthetic lethal target in the context of BRCA-mutated tumors. Exelixis’ clinical development priorities for XL309 include accelerating its development as a potential therapy for tumors that have become refractory to PARP inhibitor (“PARPi”) therapy, including forms of ovarian, breast and prostate cancers, pursuing potential PARPi combinations and moving beyond the PARPi market into new areas.
Concurrently, the company will implement a corporate restructuring to prioritize the advancement of its most promising programs. As a result, EXEL will reduce its headcount by approximately 175 employees or 13%.
Separately, its board of directors authorized the repurchase of up to an additional $450 million of the company’s common stock in 2024.
EXEL plans to file an investigational new drug (“IND”) application for the XB010 5T4-MMAE ADC program in the first half of 2024 and expects to file IND applications for the XB628 PD-L1-NKG2A bispecific antibody and XL495 small molecule PKMYT1 inhibitor programs in the second half of 2024 if preclinical data continues to remain supportive.
The strong performance of Cabometyx and encouraging pipeline progress should help Exelixis maintain its solid growth trajectory.
Zacks Rank and Another Stock to Consider
Exelixis currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the biotech sector is Regeneron Pharmaceuticals (REGN - Free Report) , which presently has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.66 per share. REGN’s stock has gained 28.5% in the past year. The company beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.