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2026-10-25 01:01 23h ago
2026-10-24 19:00 1d ago
FDA odložila rozhodnutí o zanzalintinibu na březen 2027
EXEL Exelixis
FMP Stock News 92
Original source text
Exelixis (EXEL -1.19%) has crushed the broader market this year, with its shares climbing 49%. However, the drugmaker recently hit a roadblock. The U.S. Food and Drug Administration (FDA) decided to extend the review period for Exelixis' zanzalintinib, an investigational medicine for colorectal cancer. The health regulatory agency requested more data before it can decide whether to approve the drug. A decision is now expected by March 3, 2027, pushed back from the original deadline of Dec. 3, 2026. That's not great news for Exelixis, but despite this setback, the company's prospects look attractive. Here are three reasons why.

Image source: The Motley Fool.

1. Winning the Cabometyx patent battle Exelixis' most important driver of revenue and earnings growth is Cabometyx, a medicine approved for various cancers, including liver and kidney cancers. Cabometyx is a tyrosine kinase inhibitor -- tyrosine kinase is a protein that plays a role in cell growth and division, a mechanism that is sometimes hijacked by cancer cells to promote rapid growth. Cabometyx has been one of the top-prescribed medicines of its kind in renal cell carcinoma (RCC, the most common form of kidney cancer) for years.

It has also continued to grind out new indications, including as a combination therapy. Exelixis' financial results have been strong thanks to this drug. In the second quarter, the company's revenue increased by 10.6% year over year to $628.7 million. Exelixis' earnings per share grew by about 26% year over year to $0.82.

Exelixis has done its best to delay the entry of cheaper Cabometyx generics in the U.S., and so far, it has been successful. Thanks to a patent lawsuit it won, it should not face generic competition in the U.S. at least until January 2030, perhaps even later if the company wins another patent case that starts in November. That should give Exelixis enough time to develop newer medicines to replace its crown jewel.

EXEL Exelixis$64.53-$0.78 (-1.19%)

NASDAQ · As of 4:00 PM ET 10/23/26

2. Zanzalintinib could be a pipeline-in-a-drug The most promising drug Exelixis is developing is zanzalintinib, and that's despite the recent regulatory setback. Consider the medicine's potential in colorectal cancer. It is the second leading cause of cancer death worldwide, which implies that there is a large opportunity in the market, particularly for the indication Exelixis is targeting: once it has metastasized. Further, Exelixis won't stop at this indication.

The biotech company will seek to follow the same blueprint it used for Cabometyx. Exelixis is testing zanzalintinib across several other forms of cancer. The list includes RCC, some kinds of lung cancer, and more. Of course, zanzalintinib won't earn every indication it targets. Cabometyx didn't either. But even a handful or so could make the medicine a massive commercial success and help usher in the next phase of growth for Exelixis.

Some analysts have estimated that zanzalintinib could generate $4.5 billion in U.S. sales by 2033 across various indications. Note that last year, the company made $2.3 billion in revenue, mostly from Cabometyx. Provided the sales estimates for zanzalintinib are accurate, this drug could eventually more than offset the loss of Cabometyx.

3. Exelixis' deep pipeline Even if zanzalintinib alone isn't enough to replace Cabometyx once the latter starts facing generic competition, Exelixis has a plan. The company boasts several other pipeline candidates that could eventually contribute. Although these are mostly still in early stage studies, they could make significant progress over the next five years. Most early stage candidates never make it to the market, but there is a decent chance that at least a couple of Exelixis' brand-new therapies will.

And even if none does, the company has research collaborations in place that could supply additional, oncology-focused drug candidates to its pipeline. Exelixis' ability to carve out a niche in the ruthlessly competitive oncology market, which is typically dominated by pharmaceutical giants, is fairly impressive. And over the medium term, the company could, once again, launch one or two brand-new cancer drugs that will help it sustain strong financial results and deliver competitive stock market returns.
2026-10-22 16:13 3d ago
2026-10-22 11:02 3d ago
Exelixis čeká růst zisku i tržeb
EXEL Exelixis
FMP Stock News 78
Original source text
Exelixis (EXEL - Free Report) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.

The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on October 29. On the other hand, if they miss, the stock may move lower.

While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.

Zacks Consensus EstimateThis drug developer is expected to post quarterly earnings of $0.89 per share in its upcoming report, which represents a year-over-year change of +14.1%.

Revenues are expected to be $653.06 million, up 9.3% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Exelixis?For Exelixis, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +2.44%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination indicates that Exelixis will most likely beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Exelixis would post earnings of $0.86 per share when it actually produced earnings of $0.91, delivering a surprise of +5.81%.

Over the last four quarters, the company has beaten consensus EPS estimates four times.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Exelixis appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

Expected Results of an Industry PlayerAmong the stocks in the Zacks Medical - Biomedical and Genetics industry, Biogen Inc. (BIIB - Free Report) , is soon expected to post earnings of $2.08 per share for the quarter ended September 2026. This estimate indicates a year-over-year change of -56.8%. This quarter's revenue is expected to be $2.59 billion, up 2% from the year-ago quarter.

Over the last 30 days, the consensus EPS estimate for Biogen has been revised 1.8% down to the current level. Nevertheless, the company now has an Earnings ESP of 0.00%, reflecting an equal Most Accurate Estimate.

When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Biogen will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
2026-09-17 16:24 1mo ago
2026-09-17 11:05 1mo ago
Exelixis chystá zanzalintinib, cabozantinib překonal 3 miliardy USD
EXEL Exelixis
FMP Stock News 86
Original source text
Exelixis Reports Solid Earnings—Are New Highs Back on the Table?Exelixis NASDAQ: EXEL President and CEO Michael Morrissey said the company is focused on expanding its oncology franchises through internal development, selective business development and potential collaborations, while preparing for a planned launch of zanzalintinib in metastatic colorectal cancer.

Speaking at Morgan Stanley’s Global Healthcare Conference, Morrissey said innovation originating in China has become an important consideration for the biotechnology industry. Exelixis is evaluating external opportunities, including assets from outside the United States, but is prioritizing novel programs over “fast followers” or “me-too” products.

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3 Stocks to Buy for a Soft Landing, If There Is One“We are open for business and looking very clearly at trying to expand our portfolio of franchises,” Morrissey said. He added that collaborative arrangements generally make the most sense for the company, though it may also consider acquisitions or partnerships.

AI Use Focused on Curated Data Morrissey said Exelixis is adopting artificial intelligence in a measured way rather than broadly increasing spending across its operations. The company is targeting uses of AI where it has highly curated data sets, including data from discovery, clinical development and commercial activities.

3 Strong Biotech Performers To Watch As Sector Nears BreakoutHe said the company has accumulated decades of longitudinal data and is using AI to improve the speed, depth and utility of its analyses. Commercial applications may be particularly valuable, he said, while security remains a core consideration alongside speed and data quality.

“I do not think we’re spending a lot of money, but I think we’re doing the right level of investments and the right focusing in terms of priorities to maximize impact,” Morrissey said.

On policy, Morrissey said drug pricing and most-favored-nation issues are among the leading concerns for Exelixis and the broader industry. He said the regulatory and political environment remains highly dynamic, with potential changes in Congress and future administrations creating uncertainty. The company maintains a policy team in Washington and engages with lawmakers on pricing, regulatory issues and competitive threats, he said.

Cabozantinib Remains a Major Growth Driver Morrissey said Exelixis’ cabozantinib business remains strong, with a global annualized run rate above $3 billion based on the company’s second-quarter 2026 results. Cabozantinib has been evaluated in numerous pivotal trials and has approvals across eight indications, he said.

The company recently added neuroendocrine tumors, or NET, to the cabozantinib franchise. Morrissey said growth in the indication has been somewhat slower than expected but does not change Exelixis’ long-term outlook.

Exelixis has settled with several generic manufacturers on a Jan. 1, 2031, entry date for cabozantinib. The company continues to litigate with other challengers and said a recent appellate decision supported its position. Morrissey said the company is not particularly concerned about potential 505(b)(2) competitors, which he said would face difficulty gaining adoption without significant clinical investment and data.

Zanzalintinib Launch Preparation Continues Exelixis is preparing to launch zanzalintinib in metastatic colorectal cancer following the STELLAR-303 study. Morrissey said the regulatory review timeline was extended, with the company setting the PDUFA date to March 3, as disclosed in a recent filing. He did not provide additional details beyond the company’s 8-K filing.

The delay has not changed Exelixis’ confidence in the opportunity or its resource allocation, Morrissey said. The company considers itself launch-ready and had previously expanded its gastrointestinal sales force in anticipation of a colorectal cancer launch.

Morrissey said STELLAR-303 was the only successful study among five recent trials testing checkpoint-based platform therapies in third-line or later non-MSI-high colorectal cancer. The trial evaluated zanzalintinib in combination with atezolizumab.

He said the company believes zanzalintinib’s kinase inhibition profile can affect multiple components of the tumor microenvironment, including tumor vasculature and immune cells. Exelixis views the STELLAR-303 results and its STELLAR-316 maintenance-focused trial as complementary parts of a broader colorectal cancer franchise strategy.

The late-line colorectal cancer setting represents approximately 23,000 patients and a $1.5 billion opportunity, according to the Morgan Stanley moderator. Morrissey said Exelixis has substantial overlap with its existing commercial infrastructure and is using sales, marketing and analytics capabilities to support the expected launch.

Broader Development Programs In renal cell carcinoma, Morrissey said STELLAR-304 is the first global randomized pivotal trial in non-clear-cell disease, an area he described as understudied. The trial uses sunitinib as a control arm. Exelixis is also conducting studies of zanzalintinib with belzutifan through its collaboration with Merck.

Morrissey said Exelixis is exploring additional frontline combinations, including possible bispecific antibodies and cancer vaccines. The company has an investigator-sponsored trial with Dana-Farber evaluating zanzalintinib alongside a peptide vaccine program.

For NET, he said STELLAR-311 is comparing zanzalintinib directly with everolimus, unlike the placebo-controlled CABINET trial for cabozantinib. Morrissey said the study is enrolling ahead of schedule and could expand the NET opportunity rather than simply transition existing cabozantinib patients.

Exelixis also has early-stage antibody-drug conjugate, small-molecule and bispecific programs advancing toward development decisions. Morrissey said the company will remain data-driven in determining whether to advance or discontinue programs, regardless of whether an asset originated internally or through business development.

“We just need a small number of winners,” Morrissey said. “We don’t need a big pipeline of unknowns.”

About Exelixis (NASDAQ:EXEL)Exelixis, Inc NASDAQ: EXEL is a biopharmaceutical company focused on discovering, developing and commercializing medicines for cancer and other serious diseases. The company's research and development activities center on targeted therapies designed to address biological pathways involved in tumor growth and progression.

Exelixis' principal product is cabozantinib, marketed in the United States as CABOMETYX tablets for certain patients with advanced renal cell carcinoma, hepatocellular carcinoma and radioactive iodine-refractory differentiated thyroid cancer.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

Should You Invest $1,000 in Exelixis Right Now?Before you consider Exelixis, you'll want to hear this.

MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Exelixis wasn't on the list.

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2026-09-15 12:57 1mo ago
2026-09-15 07:03 1mo ago
Exelixis chystá zanzalintinib, CABOMETYX brzdí NET
EXEL Exelixis
FMP Stock News 86
Original source text
Exelixis Reports Solid Earnings—Are New Highs Back on the Table?Exelixis NASDAQ: EXEL executives outlined plans to continue expanding the CABOMETYX franchise while preparing for a potential launch of zanzalintinib, or zanza, in colorectal cancer later this year.

Speaking at a Wells biotech session, Chief Financial Officer Chris Senner said the company is working to deepen penetration for CABOMETYX in renal cell carcinoma, or RCC, and in neuroendocrine tumors, or NET, following the NET indication launch last year. He said zanza development remains central to the company’s outlook heading into 2027.

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3 Stocks to Buy for a Soft Landing, If There Is OneAndrew Peters, senior vice president of strategy, described 2026 as a transition period in which Exelixis is seeking to grow its CABOMETYX business while investing in zanza and earlier-stage pipeline programs. The company is also considering external business-development opportunities and share repurchases as part of its capital-allocation strategy.

CABOMETYX Growth Outlook and NET Launch Dynamics Senner said Exelixis continues to view a $3 billion CABOMETYX franchise as achievable, with RCC and NET contributing to growth through 2027, 2028 and 2029. The company has described the NET opportunity as roughly a $1 billion oral-drug market at contemporary pricing.

3 Strong Biotech Performers To Watch As Sector Nears BreakoutHowever, executives said the company’s reduced CABOMETYX guidance and second-quarter revenue performance reflected a slower-than-expected ramp in NET. Senner attributed the pace to the relatively indolent nature of the disease, where patients may have longer intervals between scans and between treatment decisions than patients with other solid tumors.

Peters said CABOMETYX was capturing approximately 47% of new-patient market share in NET, characterizing that measure as a leading indicator of long-term adoption. He said the issue was primarily “a temporal dynamic” between new-patient share and overall market share, rather than a change in the underlying market opportunity.

The company said it expanded its sales force earlier this year, with the team largely in place by the end of the first quarter. Senner said the expansion began affecting NET performance in the second quarter and is expected to continue supporting commercialization efforts.

Patent Planning and Competitive Landscape Peters said Exelixis does not view 505(b)(2) products, including a tentatively approved CABOMETYX-like therapy from Handa Pharmaceuticals, as a meaningful commercial risk to its CABOMETYX business. He said such products have historically faced commercial challenges when they lack clinical data, are not AB-rated, and are not interchangeable or substitutable with the reference product.

Exelixis is focused on patient safety and enforcing its intellectual-property rights where appropriate, Peters said.

For planning purposes, the company assumes CABOMETYX generics will enter the market on Jan. 1, 2031, based on announced settlements with Teva, Cipla and others. Peters said litigation and legal challenges can continue before then, but described the 2031 date as the most appropriate assumption for company planning.

Zanza Launch Preparation and Clinical Programs Exelixis said it is preparing to launch zanza immediately if it receives approval in colorectal cancer following its PDUFA date. Senner said launch expenses are included in company guidance and the commercial organization is preparing through advisory boards and market work.

Peters said the company’s regulatory filing for zanza in colorectal cancer was based on the intent-to-treat population from the STELLAR-303 study, including patients with and without liver metastases. He said data presented at ESMO and subsequently published showed consistent benefit across subpopulations.

The company has described the third-line-and-beyond colorectal cancer market as an approximately $1.5 billion opportunity. Peters said Exelixis aims to reach as much of that market as possible, citing interest in a chemotherapy-free, checkpoint-containing treatment option and the potential benefit regardless of prior Avastin use.

Exelixis has not disclosed specific pricing plans for zanza. Senner said pricing would be “contemporary” with more recent market practices and would be determined using multiple metrics.

In RCC, Exelixis is developing zanza combinations in the LITESPARK-033 and LITESPARK-034 studies with partner Merck. Peters said the programs target areas of unmet need, including patients who progress after adjuvant pembrolizumab and later-line RCC treatment. The company also sees an opportunity in non-clear cell RCC through STELLAR-304, which excludes the chromophobe subpopulation and seeks to establish level-one evidence in a setting where treatment decisions have often relied on smaller, unrandomized studies.

Pipeline and Capital Allocation Exelixis continues to view NET as a core franchise and is investing in zanza through the STELLAR-311 first-line NET study. Peters said the slower commercial kinetics in second-line NET have not changed the company’s view of the broader NET opportunity or its approach to STELLAR-311 enrollment.

In meningioma, Peters said a phase 2 study could potentially support an accelerated-approval path if it produces a robust response rate, though he emphasized that any regulatory strategy would be data-dependent. The study’s primary endpoint is response rate, with duration of response, progression-free survival and overall survival among secondary measures.

Senner said capital allocation remains focused on three areas:

Annual research and development spending of $1 billion or less; Business-development opportunities, primarily in gastrointestinal and genitourinary areas; and Share repurchases. Through the second quarter of 2026, Exelixis had repurchased approximately $2.9 billion of stock since the second quarter of 2023, retiring about 90 million shares. The company had approximately $600 million remaining under its current repurchase authorization as of the end of the last quarter, Senner said.

About Exelixis (NASDAQ:EXEL)Exelixis, Inc NASDAQ: EXEL is a biopharmaceutical company focused on discovering, developing and commercializing medicines for cancer and other serious diseases. The company's research and development activities center on targeted therapies designed to address biological pathways involved in tumor growth and progression.

Exelixis' principal product is cabozantinib, marketed in the United States as CABOMETYX tablets for certain patients with advanced renal cell carcinoma, hepatocellular carcinoma and radioactive iodine-refractory differentiated thyroid cancer.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

Should You Invest $1,000 in Exelixis Right Now?Before you consider Exelixis, you'll want to hear this.

MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Exelixis wasn't on the list.

While Exelixis currently has a Hold rating among analysts, top-rated analysts believe these five stocks are better buys.

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2026-09-14 14:59 1mo ago
2026-09-14 04:41 1mo ago
Exelixis překonala odhady EPS i tržeb
EXEL Exelixis
FMP Stock News 78
Original source text
Integrated Wealth Concepts LLC reduced its position in shares of Exelixis, Inc. (NASDAQ:EXEL – Free Report) by 25.7% in the 2nd quarter, according to the company in its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The institutional investor owned 58,636 shares of the biotechnology company’s stock after selling 20,265 shares during the period. Integrated Wealth Concepts LLC’s holdings in Exelixis were worth $3,190,000 at the end of the most recent reporting period.

Several other institutional investors and hedge funds have also recently added to or reduced their stakes in EXEL. BlackRock Inc. bought a new position in shares of Exelixis in the 2nd quarter valued at $1,581,991,000. California State Teachers Retirement System lifted its position in shares of Exelixis by 4,875.6% during the 2nd quarter. California State Teachers Retirement System now owns 14,785,373 shares of the biotechnology company’s stock worth $804,472,000 after buying an additional 14,488,217 shares during the last quarter. AQR Capital Management LLC lifted its position in shares of Exelixis by 48.8% during the 4th quarter. AQR Capital Management LLC now owns 13,658,388 shares of the biotechnology company’s stock worth $598,647,000 after buying an additional 4,477,029 shares during the last quarter. Invesco Ltd. boosted its stake in Exelixis by 1.6% in the fourth quarter. Invesco Ltd. now owns 6,054,743 shares of the biotechnology company’s stock valued at $265,379,000 after buying an additional 94,218 shares in the last quarter. Finally, Dimensional Fund Advisors LP boosted its stake in shares of Exelixis by 0.9% in the 1st quarter. Dimensional Fund Advisors LP now owns 4,299,597 shares of the biotechnology company’s stock valued at $184,391,000 after purchasing an additional 39,920 shares in the last quarter. 85.27% of the stock is currently owned by institutional investors.

Exelixis Stock Performance EXEL stock opened at $56.12 on Monday. The stock has a market cap of $13.91 billion, a P/E ratio of 17.65, a P/E/G ratio of 1.67 and a beta of 0.42. The stock’s fifty day simple moving average is $55.35 and its two-hundred day simple moving average is $50.02. Exelixis, Inc. has a 1-year low of $33.76 and a 1-year high of $59.72.

Exelixis (NASDAQ:EXEL – Get Free Report) last announced its quarterly earnings data on Wednesday, August 5th. The biotechnology company reported $0.91 EPS for the quarter, topping the consensus estimate of $0.85 by $0.06. Exelixis had a net margin of 35.33% and a return on equity of 42.17%. The business had revenue of $628.69 million for the quarter, compared to analyst estimates of $636.40 million. During the same quarter in the previous year, the firm posted $0.75 earnings per share. The company’s revenue for the quarter was up 10.6% on a year-over-year basis. As a group, analysts forecast that Exelixis, Inc. will post 3.19 earnings per share for the current fiscal year. Insiders Place Their Bets In related news, Director Mary Beckerle sold 9,812 shares of the business’s stock in a transaction dated Monday, August 10th. The stock was sold at an average price of $53.66, for a total value of $526,511.92. Following the sale, the director directly owned 16,079 shares in the company, valued at approximately $862,799.14. The trade was a 37.90% decrease in their position. The sale was disclosed in a legal filing with the SEC, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Company insiders own 2.60% of the company’s stock.

Analyst Ratings Changes Several equities research analysts recently weighed in on the company. Barclays boosted their price objective on Exelixis from $45.00 to $49.00 and gave the stock an “equal weight” rating in a research report on Tuesday, July 14th. HC Wainwright reaffirmed a “buy” rating and issued a $56.00 price objective on shares of Exelixis in a research note on Thursday, July 2nd. BMO Capital Markets initiated coverage on Exelixis in a research note on Tuesday, August 18th. They set a “market perform” rating and a $54.00 target price for the company. William Blair restated an “outperform” rating on shares of Exelixis in a report on Friday. Finally, Wall Street Zen downgraded Exelixis from a “strong-buy” rating to a “buy” rating in a report on Saturday, August 8th. One analyst has rated the stock with a Strong Buy rating, seven have issued a Buy rating, twelve have issued a Hold rating and one has given a Sell rating to the company’s stock. According to MarketBeat.com, the company currently has a consensus rating of “Hold” and an average price target of $50.07.

Get Our Latest Research Report on Exelixis

Exelixis News Summary Here are the key news stories impacting Exelixis this week:

Neutral Sentiment: The FDA extended its review of Exelixis’ application for zanzalintinib in combination with atezolizumab for patients with metastatic colorectal cancer by three months. The new decision target is March 2027. The extension does not indicate a rejection, but it delays regulatory clarity. U.S. FDA extends review of Exelixis’ cancer drug Negative Sentiment: The delayed decision pushes back the potential launch and commercial ramp of zanzalintinib in colorectal cancer, reducing near-term visibility for investors and contributing to concern about Exelixis’ revenue outlook. Analysts are also assessing the effect of the announcement on stock volatility. Exelixis Stock Slips as FDA Delays Cancer Drug Review, Analyst Weighs In Neutral Sentiment: The FDA action follows Exelixis’ broader investor presentation and legal developments, but the reports provide no new change to the company’s existing earnings outlook or indication of a problem with its currently marketed products. Exelixis Presents at Citigroup’s Biopharma Back to School Summit 2026 Exelixis Company Profile (Free Report)

Exelixis, Inc (NASDAQ: EXEL) is a biopharmaceutical company focused on discovering, developing and commercializing medicines for cancer and other serious diseases. The company’s research and development activities center on targeted therapies designed to address biological pathways involved in tumor growth and progression.

Exelixis’ principal product is cabozantinib, marketed in the United States as CABOMETYX tablets for certain patients with advanced renal cell carcinoma, hepatocellular carcinoma and radioactive iodine-refractory differentiated thyroid cancer.

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2026-09-11 13:55 1mo ago
2026-09-11 07:30 1mo ago
FDA prodloužila přezkum kombinace Exelixis o tři měsíce
EXEL Exelixis
FMP Stock News 92
Original source text
The U.S. Food and Drug Administration ​has extended the review of Exelixis' (EXEL.O) experimental colorectal cancer drug ‌combination by three months, the company said in a filing on Friday.

The regulator will now make its decision by March 3, 2027.

Shares of the company slipped ​about 3.5% before the bell.

In response to an FDA information ​request, Exelixis submitted updated safety and efficacy data, which the ⁠health regulator classified as a major amendment, the filing showed.

The drugmaker ​did not immediately respond to a Reuters request for further details.

The company ​is seeking approval for zanzalintinib in combination with Roche's (ROPC.S) immunotherapy Tecentriq for the treatment of a subset of adult patients with metastatic colorectal cancer who have been ​previously treated.

Analysts see zanzalintinib as a key growth driver for Exelixis, ​extending the company's cancer franchise beyond its older drug Cabometyx.

"While we are surprised by ‌the ⁠three-month delay... we believe the risk of rejection remains low," said William Blair analyst Andy Hsieh.

Zanzalintinib is an oral drug belonging to the class known as tyrosine kinase inhibitors that selectively inhibit protein kinases ​that regulate cell ​growth.

In June, the ⁠combination failed to achieve statistical significance in a late-stage trial on one of two main goals measuring ​overall survival in patients without active liver metastases.

In another ​trial reported ⁠in June 2025, the combo showed statistically significant improvement in overall survival compared to Bayer's (BAYGn.DE) Stivarga in the intent-to-treat population of patients.

Intent-to-treat patients represent the ⁠largest ​commercial opportunity within the target population, William ​Blair analysts wrote in a note last month.

The company is also studying zanzalintinib in other ​types of cancer.
2026-09-04 17:08 1mo ago
2026-09-04 12:37 1mo ago
Exelixis snižuje výhled tržeb kvůli pomalejšímu růstu u NET
EXEL Exelixis
FMP Stock News 78
Original source text
A month has gone by since the last earnings report for Exelixis (EXEL - Free Report) . Shares have added about 13.3% in that time frame, outperforming the S&P 500.

Will the recent positive trend continue leading up to its next earnings release, or is Exelixis due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.

EXEL Tops Q2 Earnings Estimates, Misses on Sales, Lowers '26 View

Exelixis reported adjusted earnings per share (EPS) of 91 cents in the second quarter, which comfortably beat the Zacks Consensus Estimate of 86 cents. The company posted adjusted EPS of 75 cents in the year-ago quarter. Adjusted earnings excluded the impact of stock-based compensation expenses.

Including stock-based compensation expense, EPS was 82 cents compared with 65 cents in the year-ago period.

The bottom-line growth can be attributed to higher operating income and a decrease in shares outstanding due to ongoing buybacks.

Revenues rose 10.6% year over year to $628.7 million but missed the Zacks Consensus Estimate of $635 million.

EXEL's Product Sales Maintain Growth

Net product revenues increased to $573.03 million from $520.01 million in the year-ago quarter, primarily due to higher sales volume.

Cabometyx (cabozantinib) generated revenues of $570.6 million, which missed the Zacks Consensus Estimate of $578 million and our model estimate of $575 million. The drug is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma.

Cabometyx remained the leading prescribed tyrosine kinase inhibitor (TKI) in RCC. Its total prescription share within the company’s tracked oral TKI market basket increased to 47% from 45% a year earlier, while prescription volume rose 12%, outpacing the market basket’s 6% growth.

In March 2025, Exelixis obtained FDA approval for the label expansion of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (pNET). The drug was also approved for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).  

However, the neuroendocrine tumor indication expanded more gradually than management had projected. Exelixis attributed the slower ramp-up to the relatively indolent nature of NET, less frequent patient scans and longer transitions between therapies.

Cometriq (cabozantinib capsules) generated $2.4 million in net product revenues for treating medullary thyroid cancer.  

Collaboration revenues rose 15.4% to $55.7 million. The improvement reflected higher royalties on cabozantinib sales outside the United States by partner Ipsen, partly offset by lower development cost reimbursements. Exelixis earned $53.2 million in royalty revenues from partners Ipsen and Takeda during the quarter.

EXEL's Costs Rise as Operating Income Expands

Research and development expenses increased 5.8% year over year to $211.99 million due to higher clinical trial, manufacturing and collaboration costs as Exelixis continued investing in zanzalintinib and other pipeline candidates.

Selling, general and administrative expenses rose 9.5% to $147.63 million, reflecting higher marketing and personnel costs. Despite the increased spending, operating income climbed 16.3% to $248.41 million, and the operating margin expanded to 39.5% from 37.6%.

Exelixis Lowers Its 2026 Revenue Outlook

Management lowered its 2026 total revenue guidance to $2.50-$2.55 billion from $2.525-$2.625 billion. Net product revenue guidance was lowered to $2.30-$2.35 billion from $2.325-$2.425 billion, primarily because of the slower-than-expected NET ramp-up.

The revised outlook excludes potential revenues from zanzalintinib in previously treated metastatic colorectal cancer. Exelixis also lowered its R&D expense forecast to $825-$875 million from $875-$925 million. Its SG&A expense projection remained unchanged at $575-$625 million.

EXEL Advances Share Repurchase Program

Exelixis repurchased $311.6 million of the company’s shares in the second quarter, completing the $750 million share repurchase program (SRP) launched in October 2025.

The company also began repurchases under a new $750 million SRP authorized in May 2026, which runs through Dec. 31, 2027. Since launching its first SRP in March 2023, Exelixis has repurchased $2.9 billion of stock, retiring 93.3 million shares at an average price of $31.12 per share as of the end of the second quarter of 2026.

EXEL Advances Its Zanzalintinib Pipeline

The FDA is reviewing zanzalintinib in combination with Roche’s Tecentriq for previously treated metastatic colorectal cancer, with a target action date of Dec. 3, 2026. Its approval would establish zanzalintinib as Exelixis’ second commercial oncology franchise and broaden its portfolio beyond cabozantinib.

In June 2026, Exelixis reported final phase III STELLAR-303 results showing a non-statistically significant overall survival trend favoring zanzalintinib plus Tecentriq over regorafenib in the non-liver metastases (NLM) subgroup of previously treated non-MSI-high metastatic colorectal cancer. The study had previously met its other dual primary endpoint of overall survival in the intent-to-treat population, which included all randomized patients regardless of the presence of active liver metastases, as reported in June 2025.

Roche’s Tecentriq is a cancer immunotherapy that is approved around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various types of cancer.

EXEL has collaborated with Merck to evaluate zanzalintinib, in combination with subcutaneous Keytruda Qlex in the planned phase III STELLAR-316 study for resected stage II/III colorectal cancer (CRC).

Under the agreement, Exelixis will sponsor the STELLAR-316 study, while Merck will provide Keytruda Qlex for use in the same. Keytruda is approved for several types of cancer.

Exelixis expects to initiate STELLAR-316 shortly, which will evaluate zanzalintinib with and without Keytruda Qlex in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease — a high-risk population with substantial unmet need.

Earlier this year, Exelixis partnered with Natera, a global leader in cell-free DNA and precision medicine, for this study.

Natera will supply its Signatera assay to identify eligible MRD-positive patients for enrollment, further integrating precision medicine into the program.

The Merck partnership extends beyond colorectal cancer. In April 2026, Merck initiated the phase III LITESPARK-034 trial evaluating zanzalintinib plus Welireg versus Welireg and placebo in previously treated advanced RCC patients who progressed after PD-1/L1 and VEGFR-TKI therapies.

This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy.

In May 2026, Exelixis announced the initiation of STELLAR-201, a phase II study evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies.
 

How Have Estimates Been Moving Since Then?It turns out, estimates revision have trended upward during the past month.

VGM ScoresAt this time, Exelixis has a strong Growth Score of A, though it is lagging a lot on the Momentum Score front with an F. However, the stock has a score of B on the value side, putting it in the second quintile for value investors.

Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in.

OutlookEstimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Exelixis has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.

Performance of an Industry PlayerExelixis is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Biogen Inc. (BIIB - Free Report) , a stock from the same industry, has gained 8.8%. The company reported its results for the quarter ended June 2026 more than a month ago.

Biogen reported revenues of $2.74 billion in the last reported quarter, representing a year-over-year change of +3.4%. EPS of $3.60 for the same period compares with $5.47 a year ago.

For the current quarter, Biogen is expected to post earnings of $2.31 per share, indicating a change of -52% from the year-ago quarter. The Zacks Consensus Estimate has changed -4.6% over the last 30 days.

The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Biogen. Also, the stock has a VGM Score of C.
2026-08-17 00:29 2mo ago
2026-08-16 18:24 2mo ago
Exelixis čelí vyšetřování po slabých tržbách a snížení výhledu
EXEL Exelixis
FMP Stock News 78
Original source text
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LOS ANGELES--(BUSINESS WIRE)--Schall, Brown & Schwartz LLP (“SBS”), a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Exelixis, Inc. (“Exelixis” or “the Company”) (NASDAQ: EXEL) for violations of the securities laws.

INVESTIGATION DETAILS: The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Exelixis missed analyst consensus estimates with its Q2 revenue and also lowered its full-year 2026 revenue guidance.

The revenue shortfall came alongside an adjusted EPS beat of $0.91 per share. Investors sold on the top-line number. The Company attributed the reduced full-year outlook to a slower-than-expected ramp in its neuroendocrine-tumor business -- a franchise Exelixis had described to investors as a market-leading position for CABOMETYX in the oral second-line plus segment.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall or David Schwartz of Schall, Brown & Schwartz LLP, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected]

WHY SBS? Schall, Brown & Schwartz LLP represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. Bringing together the extensive experience and diverse skillsets of founding partners Brian Schall, Andrew Brown, and David Schwartz, SBS is dedicated to aggressively advocating for every investor.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

More News From Schall, Brown & Schwartz LLP

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2026-08-05 23:44 2mo ago
2026-08-05 19:11 2mo ago
Exelixis překonal odhad zisku na akcii, tržby mírně zaostaly
EXEL Exelixis
FMP Stock News 78
Original source text
Exelixis (EXEL - Free Report) came out with quarterly earnings of $0.91 per share, beating the Zacks Consensus Estimate of $0.86 per share. This compares to earnings of $0.75 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +5.81%. A quarter ago, it was expected that this drug developer would post earnings of $0.75 per share when it actually produced earnings of $0.87, delivering a surprise of +16%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Exelixis, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $628.69 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 0.99%. This compares to year-ago revenues of $568.26 million. The company has topped consensus revenue estimates two times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Exelixis shares have added about 27.8% since the beginning of the year versus the S&P 500's gain of 13%.

What's Next for Exelixis?While Exelixis has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Exelixis was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.87 on $659.3 million in revenues for the coming quarter and $3.53 on $2.59 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Arcturus Therapeutics (ARCT - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 6.

This pharmaceutical company is expected to post quarterly loss of $1.07 per share in its upcoming report, which represents a year-over-year change of -214.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Arcturus Therapeutics' revenues are expected to be $2.51 million, down 91.1% from the year-ago quarter.
2026-07-09 19:45 3mo ago
2026-07-09 15:26 3mo ago
Exelixis čeká na rozhodnutí FDA o zanzalintinibu
EXEL Exelixis
FMP Stock News 78
Original source text
Key Takeaways Exelixis awaits an FDA decision on zanzalintinib for metastatic colorectal cancer by Dec. 3, 2026.EXEL expanded zanzalintinib studies with Merck across colorectal and renal cell cancer programs.Zanzalintinib is also advancing in lung and prostate cancer studies, broadening its potential use. Shares of Exelixis, Inc. (EXEL - Free Report) have surged 26.8% in three months, outperforming the industry’s gain of 4.5%.  The stock touched a high of $57.57 on July 7.

The stock has outperformed the sector and the S&P 500 Index during this time frame.

EXEL Outperforms Industry, Sector & S&P 500 Index
Image Source: Zacks Investment Research

The broader market recovery and investors' optimism about the company's pipeline momentum are most likely contributing to the rally, notwithstanding the recent pipeline setback. In such a scenario, a deeper assessment of the company's growth drivers and potential risks will be essential to determine whether current levels represent an attractive entry point.

EXEL’s Progress With Lead Candidate ZanzalintinibZanzalintinib is Exelixis' most important late-stage pipeline asset and represents the company's key growth driver as it seeks to diversify beyond its flagship cancer therapy, cabozantinib (marketed as Cabometyx). The next-generation oral investigational tyrosine kinase inhibitor (TKI) targets multiple pathways, giving it potential across several difficult-to-treat cancers.

The company's near-term investment thesis hinges on the regulatory outcome for zanzalintinib.

EXEL’s new drug application seeking approval of zanzalintinib in combination with Roche’s (RHHBY - Free Report) Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC) is under review in the United States. The targeted population includes patients who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if they are RAS wild-type, an anti-epidermal growth factor receptor therapy.

The agency has set a target action date of Dec. 3, 2026.

A positive decision would mark the first approval for zanzalintinib and establish a new commercial growth platform beyond Cabometyx.

The company's recent disappointment stemmed from the final analysis of the dual primary endpoint of overall survival (OS) in the subset of patients without active liver metastases (non-liver metastases, NLM) in the late-stage STELLAR-303 study, evaluating zanzalintinib plus Tecentriq versus regorafenib in previously treated non-microsatellite instability (MSI)-high mCRC.

This showed a non-statistically significant trend in OS favoring the combination in the NLM subpopulation. Median OS was 15.9 months for patients treated with the combination therapy compared with 12.7 months for those receiving regorafenib.    
The disappointing results are a setback in the company’s efforts to get approval for zanzalintinib.

Meanwhile, Exelixis continues to aggressively expand zanzalintinib's development program through strategic partnerships and multiple late-stage clinical studies.

The company recently broadened its collaboration with Merck (MRK - Free Report) to evaluate zanzalintinib in combination with subcutaneous Keytruda Qlex in the planned phase III STELLAR-316 study in patients with resected stage II/III colorectal cancer (CRC).

Exelixis will sponsor the study, while Merck will supply Keytruda Qlex. The study will evaluate zanzalintinib with and without Keytruda Qlex in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease.

Exelixis has also partnered with Natera, a global leader in cell-free DNA and precision medicine, whose Signatera molecular residual disease assay will be used to identify eligible patients for STELLAR-316.

The Merck partnership extends beyond colorectal cancer. In April 2026, Merck initiated the phase III LITESPARK-034 trial evaluating zanzalintinib plus Welireg versus Welireg and placebo in previously treated advanced renal cell carcinoma (RCC) patients who progressed after PD-1/L1 and VEGFR-TKI therapies.

This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy.

These studies highlight Merck's confidence in zanzalintinib's potential across multiple RCC treatment settings while substantially expanding Exelixis' long-term growth opportunities.Beyond CRC and RCC, Exelixis is advancing additional indications for zanzalintinib through the planned phase II STELLAR-202 study in squamous non-small cell lung cancer and an expansion cohort in the ongoing phase Ib/II STELLAR-002 trial in metastatic castration-resistant prostate cancer. Success in any of these indications could significantly broaden the drug's commercial opportunity.

Roche’s Tecentriq is a cancer immunotherapy that is approved around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various types of cancer.

EXEL’s Cabometyx Maintains MomentumLead drug Cabometyx is approved for advanced RCC and previously treated hepatocellular carcinoma.

In March 2025, Exelixis obtained FDA approval for the label expansion of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (pNET). The drug was also approved for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).  

The Cabometyx franchise continued to gain momentum in 2026, maintaining its position as the leading prescribed TKI in renal cell carcinoma, the top TKI plus immunotherapy combination in first-line RCC, and the leading oral option in second-line and later neuroendocrine tumors.

Invest in EXEL StockWhile the STELLAR-303 results have tempered near-term expectations, zanzalintinib remains Exelixis' most most significant near-term catalyst. The upcoming FDA decision, multiple late-stage trials, and deepening collaborations with Merck and Natera provide several value-creating catalysts.

Positive regulatory and clinical outcomes could meaningfully diversify Exelixis' revenue base beyond Cabometyx and support the company's long-term growth trajectory.

We remain bullish on the stock's prospects and believe it offers additional upside potential. Accordingly, we view the shares favorably for prospective investors, while existing shareholders may consider maintaining their positions to capitalize on further growth opportunities.

EXEL’s Zacks Rank