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Will Exelixis (EXEL) be Able to Carry '17 Momentum in 2018?
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Shares of Exelixis, Inc. (EXEL - Free Report) have rallied a massive 106.6% year to date compared with the industry’s gain of 5.2%.
Exelixis’ lead product, Cometriq, the capsule form of cabozantinib, was approved in the United State in 2012 for the treatment of progressive, metastatic medullary thyroid cancer. In April 2016, a tablet formulation of cabozantinib, Cabometyx was approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
Cabometyx posted strong sales in the first nine months of 2017 thereby underlying the increasing demand for the drug. New patient market share in the second-line plus setting increased to 38%.
The recent FDA approval of Cabometyx for the treatment previously untreated advanced RCC should further boost demand.
The approval comes two months ahead of schedule. We note that Cabometyx (cabozantinib), a tyrosine kinase inhibitor, or TKI, was already approved for the treatment of RCC in patients who have already received anti-angiogenic therapy. Cabozantinib inhibits the activity of tyrosine kinases, including MET, AXL, VEGF receptors, and RET. The approval came on the back of results from the randomized phase II, trial CABOSUN. The results demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus the current standard of care, Pfizer Inc.’s (PFE - Free Report) Sutent. Importantly, Cabometyx demonstrated a clinically meaningful and statistically significant 52% reduction in the rate of disease progression or death. Median PFS for Cabometyx was 8.6 months versus 5.3 months for Sutent corresponding to a 3.3 month (62%) improvement.
RCC is the most common form of kidney cancer in adults. Per statistics, approximately 30,000 patients in the United States and 68,000 around the world need a first-line treatment for advanced kidney cancer. As many as 14,000 patients need the same annually in the United States.
Sutent is widely used as a first-line treatment for RCC. Hence, we expect Cabometyx will pose a challenge to Sutent’s market share for first line RCC in 2018.
In addition, the drug is also being evaluated for advanced hepatocellular carcinoma (HCC) in the CELESTIAL study. In October 2017, Exelixis announced that the CELESTIAL trial met its primary endpoint of overall survival (OS) with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared with placebo in patients with advanced HCC. The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. Exelixis plans to submit an sNDA to the FDA in the first quarter of 2018. HCC is the most common form of primary liver cancer, accounting for more than 90% of cases in the United States. reflecting the demand for therapies. Hence, a potential approval of the drug for liver cancer will further boost the growth potential of the drug.
In early 2017, Exelixis inked agreements with Bristol-Myers Squibb (BMY - Free Report) and Roche Holdings (RHHBY - Free Report) to jointly develop cabozantinib in combination with immunotherapy agents. Exelixis collaborated with Bristol-Myers to evaluate cabozantinib in combination with Opdivo alone or in combination with Yervoy in a phase III trial in first-line RCC, and potentially in other tumor types including (HCC and bladder cancer). Both companies have initiated a phase III trial, CheckMate 9ER in July 2017 to evaluate Opdivo in combination with Cabometyx or Opdivo and Yervoy in combination with Cabometyx versus Sutent in patients with previously untreated, advanced or metastatic RCC. Exelixis has also collaborated with Roche to evaluate Cabometyx in combination with Tecentriq, an anti-PD-L1 antibody, in patients with advanced RCC or bladder cancer. In June 2017, Exelixis initiated the dose-escalation stage of a phase Ib trial of cabozantinib in combination with Tecentriq. The drug will be evaluated in patients suffering from locally advanced or metastatic urothelial carcinoma or RCC.
While competition might stiffen up a bit in 2018 as the the FDA accepted Bristol-Myers’ supplemental Biologics License Application for priority review of Opdivo plus Yervoy to treat intermediate- and poor-risk patients with advanced RCC with an action date of Apr 16, 2018, we expect Exelixis to ride high on the performance of Cabometyx in 2018.
Hence, this is a must-have stock for investors in their biotech portfolio in 2018.
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Will Exelixis (EXEL) be Able to Carry '17 Momentum in 2018?
Shares of Exelixis, Inc. (EXEL - Free Report) have rallied a massive 106.6% year to date compared with the industry’s gain of 5.2%.
Exelixis’ lead product, Cometriq, the capsule form of cabozantinib, was approved in the United State in 2012 for the treatment of progressive, metastatic medullary thyroid cancer. In April 2016, a tablet formulation of cabozantinib, Cabometyx was approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
Cabometyx posted strong sales in the first nine months of 2017 thereby underlying the increasing demand for the drug. New patient market share in the second-line plus setting increased to 38%.
The recent FDA approval of Cabometyx for the treatment previously untreated advanced RCC should further boost demand.
The approval comes two months ahead of schedule. We note that Cabometyx (cabozantinib), a tyrosine kinase inhibitor, or TKI, was already approved for the treatment of RCC in patients who have already received anti-angiogenic therapy. Cabozantinib inhibits the activity of tyrosine kinases, including MET, AXL, VEGF receptors, and RET. The approval came on the back of results from the randomized phase II, trial CABOSUN. The results demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus the current standard of care, Pfizer Inc.’s (PFE - Free Report) Sutent. Importantly, Cabometyx demonstrated a clinically meaningful and statistically significant 52% reduction in the rate of disease progression or death. Median PFS for Cabometyx was 8.6 months versus 5.3 months for Sutent corresponding to a 3.3 month (62%) improvement.
RCC is the most common form of kidney cancer in adults. Per statistics, approximately 30,000 patients in the United States and 68,000 around the world need a first-line treatment for advanced kidney cancer. As many as 14,000 patients need the same annually in the United States.
Sutent is widely used as a first-line treatment for RCC. Hence, we expect Cabometyx will pose a challenge to Sutent’s market share for first line RCC in 2018.
In addition, the drug is also being evaluated for advanced hepatocellular carcinoma (HCC) in the CELESTIAL study. In October 2017, Exelixis announced that the CELESTIAL trial met its primary endpoint of overall survival (OS) with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared with placebo in patients with advanced HCC. The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. Exelixis plans to submit an sNDA to the FDA in the first quarter of 2018. HCC is the most common form of primary liver cancer, accounting for more than 90% of cases in the United States. reflecting the demand for therapies. Hence, a potential approval of the drug for liver cancer will further boost the growth potential of the drug.
In early 2017, Exelixis inked agreements with Bristol-Myers Squibb (BMY - Free Report) and Roche Holdings (RHHBY - Free Report) to jointly develop cabozantinib in combination with immunotherapy agents. Exelixis collaborated with Bristol-Myers to evaluate cabozantinib in combination with Opdivo alone or in combination with Yervoy in a phase III trial in first-line RCC, and potentially in other tumor types including (HCC and bladder cancer). Both companies have initiated a phase III trial, CheckMate 9ER in July 2017 to evaluate Opdivo in combination with Cabometyx or Opdivo and Yervoy in combination with Cabometyx versus Sutent in patients with previously untreated, advanced or metastatic RCC. Exelixis has also collaborated with Roche to evaluate Cabometyx in combination with Tecentriq, an anti-PD-L1 antibody, in patients with advanced RCC or bladder cancer. In June 2017, Exelixis initiated the dose-escalation stage of a phase Ib trial of cabozantinib in combination with Tecentriq. The drug will be evaluated in patients suffering from locally advanced or metastatic urothelial carcinoma or RCC.
While competition might stiffen up a bit in 2018 as the the FDA accepted Bristol-Myers’ supplemental Biologics License Application for priority review of Opdivo plus Yervoy to treat intermediate- and poor-risk patients with advanced RCC with an action date of Apr 16, 2018, we expect Exelixis to ride high on the performance of Cabometyx in 2018.
Hence, this is a must-have stock for investors in their biotech portfolio in 2018.
Zacks Rank
Exelixis carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>