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2026-09-04 17:08 5d ago
2026-09-04 12:37 5d 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 23d ago
2026-08-16 18:24 24d 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 1mo ago
2026-08-05 19:11 1mo 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 2mo ago
2026-07-09 15:26 2mo 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