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Exelixis Gains 15.6% YTD: How Should You Play the Stock?
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Key Takeaways
Cabometyx sales grow with strong RCC demand and new NET label expansion.
Zanzalintinib combo met a key endpoint in the STELLAR-303 CRC study.
Q2 revenue miss and RCC competition weigh on EXEL's near-term outlook.
Exelixis’ (EXEL - Free Report) year-to-date performance has been good. Shares of the biotech company have gained 15.6% compared with the industry’s growth of 2.9%. While shares hit a 52-week high of $49.62 on June 23, 2025, it dipped after the company reported second-quarter results on July 28.
Nonetheless, despite the slide, the stock has outperformed the sector and the S&P 500 Index in the said time frame.
EXEL Outperforms Industry, Sector & S&P 500
Image Source: Zacks Investment Research
While positive updates on promising pipeline candidate, zanzalintinib, boosted the stock earlier on, the company’s mixed quarterly results disappointed investors.
In such a scenario, let’s delve deeper and analyze the company’s strengths and weaknesses to make an informed investment decision.
EXEL’s Lead Drug Cabometyx Maintains Momentum
Cabometyx maintains its status as the leading tyrosine kinase inhibitor (TKI) for the treatment of renal cell carcinoma (RCC) in both the frontline immuno-oncology (IO) +TKI market and the second-line monotherapy segment.
The drug is also approved for use in combination with Bristol Myers’ (BMY - Free Report) Opdivoin the first-line setting in RCC. Demand has been strong for this combination, boosting sales.
BMY’s Opdivois one of the leading IO drugs and has been approved for various oncology indications.
The recent label expansion of cabozantinibfor adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) and those with previously treated advanced extra-pancreatic NET should further fuel sales.
Cabometyxis now the first and only systemic treatment that is FDA approved for previously treated NET, regardless of primary tumor site, grade, somatostatin receptor expression and functional status.
Demand for this new indication was just over 4% of the total demand for cabozantinib in the second quarter and EXEL expects that contribution to increase going forward.
In July, Exelixis announced that its partner Ipsen received regulatory approval for Cabometyx for adult patients with unresectable or metastatic, well-differentiated extra-pancreatic and pNET neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues.
Positive Data on Zanzalintinib Boosts EXEL
EXEL is developing zanzalintinib — a next-generation oral investigational tyrosine kinase inhibitor (TKI) — which inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER.
The company recently announced positive top-line results from the late-stage STELLAR-303 study, which is an open-label study that randomized 901 patients equally to receive either Tzanzalintinib (100 mg) in combination with Tecentriq (atezolizumab) or Stivarga (regorafenib). The study includes patients with previously non-microsatellite instability-high metastatic colorectal cancer (CRC).
The STELLAR-303 study met one of its dual primary endpoints, demonstrating a statistically significant improvement in overall survival (OS) for the intent-to-treat (ITT) population when treated with zanzalintinib in combination with Tecentriq compared with the current standard-of-care drug, regorafenib.
Exelixis stated that the trial will continue to a final analysis of the second primary endpoint — OS in the subgroup without liver metastases (non-liver metastases, or NLM).
The positive data from this study represent a pivotal achievement for Exelixis, increasing the likelihood of regulatory success. Zanzalintinib is currently being developed for the treatment of other oncology indications.
However, Exelixis has decided not to proceed to the phase III portion of the STELLAR-305 trial on zanzalintinib. The decision was based on the company’s evaluation of emerging data from the phase II portion of the STELLAR-305 trial in advanced squamous cell carcinoma of the head and neck, emerging competition in this indication, and assessment of other, potentially larger, commercial opportunities.
EXEL Makes Encouraging Pipeline Progress
The pipeline progress is encouraging as well as Exelixis looks to expand its portfolio.
Exelixis now has three ongoing phase I studies — XL309, XB010 and XB628 — for its pipeline programs. Additionally, in July, the FDA cleared Exelixis’ IND application for XB371 and the company plans to initiate the phase I study in the coming months.
EXEL’s Valuation & Estimates
From a valuation standpoint, EXEL is expensive. Going by the price/sales ratio, its shares currently trade at 4.14x forward sales, higher than its mean of 3.64x and the biotech industry’s 1.59x.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has risen from $2.64 to $2.68, while that for 2026 has decreased to $3.09 from $3.13 over the past 30 days.
Image Source: Zacks Investment Research
Stay Invested in EXEL Stock
Exelixis' lead drug, Cabometyx, maintains momentum for the company. The label expansion of Cabometyxshould boost its growth. EXEL’s efforts to expand its portfolio are encouraging as well. The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug.
However, any developmental or regulatory setback for zanzalintinibwill be a hindrance for EXEL. The recent quarterly revenue miss also disappointed investors. Cabometyxfaces stiff competition in the RCC space from the combination of Merck’s (MRK - Free Report) Keytruda (pembrolizumab) and Pfizer’s Inlyta (axitinib).
On a standalone basis, Keytruda is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or nephrectomy and resection of metastatic lesions. Keytruda is currently approved for several types of cancer and alone accounts for around 50% of MRK’s pharmaceutical sales.
We recommend prospective investors to wait for now before turning positive. For existing investors, the company’s efforts to increase shareholder value are impressive and should boost returns.
Image: Bigstock
Exelixis Gains 15.6% YTD: How Should You Play the Stock?
Key Takeaways
Exelixis’ (EXEL - Free Report) year-to-date performance has been good. Shares of the biotech company have gained 15.6% compared with the industry’s growth of 2.9%. While shares hit a 52-week high of $49.62 on June 23, 2025, it dipped after the company reported second-quarter results on July 28.
Nonetheless, despite the slide, the stock has outperformed the sector and the S&P 500 Index in the said time frame.
EXEL Outperforms Industry, Sector & S&P 500
Image Source: Zacks Investment Research
While positive updates on promising pipeline candidate, zanzalintinib, boosted the stock earlier on, the company’s mixed quarterly results disappointed investors.
In such a scenario, let’s delve deeper and analyze the company’s strengths and weaknesses to make an informed investment decision.
EXEL’s Lead Drug Cabometyx Maintains Momentum
Cabometyx maintains its status as the leading tyrosine kinase inhibitor (TKI) for the treatment of renal cell carcinoma (RCC) in both the frontline immuno-oncology (IO) +TKI market and the second-line monotherapy segment.
The drug is also approved for use in combination with Bristol Myers’ (BMY - Free Report) Opdivoin the first-line setting in RCC. Demand has been strong for this combination, boosting sales.
BMY’s Opdivois one of the leading IO drugs and has been approved for various oncology indications.
The recent label expansion of cabozantinibfor adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) and those with previously treated advanced extra-pancreatic NET should further fuel sales.
Cabometyxis now the first and only systemic treatment that is FDA approved for previously treated NET, regardless of primary tumor site, grade, somatostatin receptor expression and functional status.
Demand for this new indication was just over 4% of the total demand for cabozantinib in the second quarter and EXEL expects that contribution to increase going forward.
In July, Exelixis announced that its partner Ipsen received regulatory approval for Cabometyx for adult patients with unresectable or metastatic, well-differentiated extra-pancreatic and pNET neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues.
Positive Data on Zanzalintinib Boosts EXEL
EXEL is developing zanzalintinib — a next-generation oral investigational tyrosine kinase inhibitor (TKI) — which inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER.
The company recently announced positive top-line results from the late-stage STELLAR-303 study, which is an open-label study that randomized 901 patients equally to receive either Tzanzalintinib (100 mg) in combination with Tecentriq (atezolizumab) or Stivarga (regorafenib). The study includes patients with previously non-microsatellite instability-high metastatic colorectal cancer (CRC).
The STELLAR-303 study met one of its dual primary endpoints, demonstrating a statistically significant improvement in overall survival (OS) for the intent-to-treat (ITT) population when treated with zanzalintinib in combination with Tecentriq compared with the current standard-of-care drug, regorafenib.
Exelixis stated that the trial will continue to a final analysis of the second primary endpoint — OS in the subgroup without liver metastases (non-liver metastases, or NLM).
The positive data from this study represent a pivotal achievement for Exelixis, increasing the likelihood of regulatory success. Zanzalintinib is currently being developed for the treatment of other oncology indications.
However, Exelixis has decided not to proceed to the phase III portion of the STELLAR-305 trial on zanzalintinib. The decision was based on the company’s evaluation of emerging data from the phase II portion of the STELLAR-305 trial in advanced squamous cell carcinoma of the head and neck, emerging competition in this indication, and assessment of other, potentially larger, commercial opportunities.
EXEL Makes Encouraging Pipeline Progress
The pipeline progress is encouraging as well as Exelixis looks to expand its portfolio.
Exelixis now has three ongoing phase I studies — XL309, XB010 and XB628 — for its pipeline programs. Additionally, in July, the FDA cleared Exelixis’ IND application for XB371 and the company plans to initiate the phase I study in the coming months.
EXEL’s Valuation & Estimates
From a valuation standpoint, EXEL is expensive. Going by the price/sales ratio, its shares currently trade at 4.14x forward sales, higher than its mean of 3.64x and the biotech industry’s 1.59x.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has risen from $2.64 to $2.68, while that for 2026 has decreased to $3.09 from $3.13 over the past 30 days.
Image Source: Zacks Investment Research
Stay Invested in EXEL Stock
Exelixis' lead drug, Cabometyx, maintains momentum for the company. The label expansion of Cabometyxshould boost its growth. EXEL’s efforts to expand its portfolio are encouraging as well. The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug.
However, any developmental or regulatory setback for zanzalintinibwill be a hindrance for EXEL. The recent quarterly revenue miss also disappointed investors. Cabometyxfaces stiff competition in the RCC space from the combination of Merck’s (MRK - Free Report) Keytruda (pembrolizumab) and Pfizer’s Inlyta (axitinib).
On a standalone basis, Keytruda is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or nephrectomy and resection of metastatic lesions. Keytruda is currently approved for several types of cancer and alone accounts for around 50% of MRK’s pharmaceutical sales.
We recommend prospective investors to wait for now before turning positive. For existing investors, the company’s efforts to increase shareholder value are impressive and should boost returns.
EXEL currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.