--- title: "Exelixis (EXEL) news: buyback" url: "https://aibio.space/companies/exelixis/" publisher: "aibio.space (Biotech Investor Relations News)" summary: "EXEL buyback news. Exelixis news for investors: Exelixis is a cancer drug company that sells the kidney and liver cancer drug Cabometyx and is developing a…" --- Desk view · Opinion · Updated Oct 22, 2026 ## Exelixis has a profitable base and a delayed successor Exelixis earns about $2.5 billion a year from one drug and is spending on a successor whose first application just hit a three-month review delay. The cash flow and a 2030 patent floor on Cabometyx give it time, but the colorectal data are mixed and the safety profile is heavier than the control arm's. The STELLAR-304 kidney cancer readout is the next test of whether zanzalintinib can stand beyond one indication. Read the full desk view aibio.space Investor Rank · Opinion **7** /10 Positive view Profitable on cabozantinib with patents to at least 2030, but zanzalintinib's colorectal data were mixed, its FDA review slipped, and all product revenue is one drug. - **Technology**: 2/2 - **Odds**: 1/2 - **Balance sheet**: 2/2 - **Risk**: 1/2 - **Momentum**: 1/2 Opinion only. The Investor Rank is aibio.space's opinion of the company's business position, drawn from the public sources on this page. It is not a recommendation to buy, sell or hold any security and it is not investment advice. It does not consider the share price, valuation or your circumstances, and it can change at any time. Payments from companies never affect it. [How the rank works](https://aibio.space/disclosures/#rank). - **Technology**: **One proven drug, one challenger.** Cabozantinib is a commercial success at $573.0 million a quarter in the U.S.; zanzalintinib is a follow-on inhibitor in seven ongoing or soon-to-start phase 3 programs. - **Odds**: **Mixed colorectal data.** The trial met overall survival in all patients (hazard ratio 0.80) but missed the non-liver-metastases endpoint, and the FDA review now runs to March 3, 2027. - **Balance sheet**: **Profitable with a shrinking cushion.** Cash and securities were $1.4 billion at June 30, down from $1.7 billion in six months, as repurchases totaled $2.9 billion since 2023. - **Main risk**: **Single-product concentration.** All product revenue is cabozantinib, and generic filers include six companies, though the court bars MSN's approval before January 2030 for now. - **Watch next**: **Kidney readout, then the FDA.** STELLAR-304 topline is due in the second half of 2026 and the colorectal decision on March 3, 2027. ## Top news on Exelixis 1. 2026-05-05 Financings [Exelixis authorizes another $750 million buyback as first-quarter revenue hits $610.8 million](https://aibio.space/news/exelixis-authorizes-another-750-million-buyback-first-quarter-revenue/) The new program runs through Dec. 31, 2027. First-quarter net product revenue was $555.0 million and 2026 guidance was left unchanged. ## Dates **Second half of 2026** Topline results from phase 3 STELLAR-304 (zanzalintinib + nivolumab vs sunitinib, non-clear cell RCC), depending on event rates [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) **November 2026** Delaware trial on U.S. Patent No. 12,128,039 (expires 2032) in the MSN generic case [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000104/exel-20260831.htm) **March 3, 2027** FDA PDUFA action date for zanzalintinib + atezolizumab in metastatic colorectal cancer [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) ## The money $1.4 billion in cash, cash equivalents and marketable securities at June 30, 2026 (down from $1.7 billion at Dec. 31, 2025). The 10-Q says cash and revenues should fund operations for at least 12 months and thereafter for the foreseeable future. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) Q2 2026 total revenue $628.7 million, including $573.0 million net product revenue and $55.7 million collaboration revenue. 2026 total revenue guidance $2.500 billion to $2.550 billion. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) ## Risks on the record - All product revenue comes from cabozantinib; generic applications are pending from MSN, Teva, Cipla, Biocon, Sun and Accord, and the Federal Circuit ruling bars MSN's final approval before Jan. 15, 2030 only subject to further proceedings. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) - The FDA extended the zanzalintinib review by three months after a major amendment; STELLAR-303 showed 60% grade 3 or higher treatment-related events against 37% for regorafenib and missed its non-liver-metastases endpoint. [Source](https://www.onclive.com/view/zanzalintinib-plus-atezolizumab-misses-os-end-point-in-non-liver-metastases-subgroup-in-refractory-mcrc) - Share repurchases have reduced cash and marketable securities from $1.7 billion to $1.4 billion in the first half of 2026. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) ## Questions investors ask ### What is aibio.space's Investor Rank for Exelixis? 7 out of 10, our positive view. Profitable on cabozantinib with patents to at least 2030, but zanzalintinib's colorectal data were mixed, its FDA review slipped, and all product revenue is one drug. This is opinion only, not a recommendation to buy, sell or hold, and it does not consider the share price or valuation. [Source](https://aibio.space/disclosures/#rank) ### When will the FDA decide on Exelixis's zanzalintinib? The FDA set a new action date of March 3, 2027, after extending the review by three months on Sept. 10, 2026. The earlier date was Dec. 3, 2026. The agency treated updated data as a major amendment. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) ### Why did the FDA extend the zanzalintinib review? Exelixis said it had submitted updated safety and efficacy data in response to an FDA information request, and the FDA deemed it a major amendment. The company's filing does not say what the data covered or what the agency asked. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) ### Is the Cabometyx patent challenge from MSN over? No. On Aug. 31, 2026 the Federal Circuit upheld three patents, which per Exelixis bars final FDA approval of MSN's generic before Jan. 15, 2030, subject to further proceedings. A trial on a separate patent expiring in 2032 is scheduled for November 2026. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000104/exel-20260831.htm) ### How much cash does Exelixis have? Exelixis held $1.4 billion in cash, cash equivalents and marketable securities at June 30, 2026, compared with $1.7 billion at the end of 2025. The 10-Q says its cash and revenues should fund operations for at least 12 months and beyond. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) ### What was Exelixis's 2026 revenue guidance after the second quarter? On Aug. 5, 2026 Exelixis guided to total revenue of $2.500 billion to $2.550 billion and net product revenue of $2.300 billion to $2.350 billion. Both ranges exclude any revenue from a zanzalintinib approval. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) ### What is the latest Exelixis (EXEL) stock news? Our latest story on Exelixis, dated May 5, 2026: "Exelixis authorizes another $750 million buyback as first-quarter revenue hits $610.8 million". The new program runs through Dec. 31, 2027. First-quarter net product revenue was $555.0 million and 2026 guidance was left unchanged. [Source](https://aibio.space/news/exelixis-authorizes-another-750-million-buyback-first-quarter-revenue/) ### What is Exelixis's latest stock offering or financing news? Our latest financing story, dated May 5, 2026: "Exelixis authorizes another $750 million buyback as first-quarter revenue hits $610.8 million". The new program runs through Dec. 31, 2027. First-quarter net product revenue was $555.0 million and 2026 guidance was left unchanged. [Source](https://aibio.space/news/exelixis-authorizes-another-750-million-buyback-first-quarter-revenue/) ### What is Exelixis's market cap? We do not publish live share prices. In its annual report, Exelixis, Inc. put the market value of shares held by non-affiliates (public float) at $9.40 billion as of Jul 4, 2025. Source ### Is Exelixis a smaller reporting company? SEC records list Exelixis, Inc.'s filer category as: Large accelerated filer. Source ### Where is Exelixis headquartered? SEC records list its business address as 1851 HARBOR BAY PARKWAY, ALAMEDA, CA, 94502. Source ### When does Exelixis's fiscal year end? Exelixis, Inc.'s fiscal year ends on January 1, per SEC records. Source ### What did Exelixis last file with the SEC? Its most recent filing in our record is an 8-K filed 2026-09-11. All of its filings are on SEC EDGAR. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) ### What was Exelixis called before? SEC records list these former names: EXELIXIS INC. Source ### What industry is Exelixis in? Its SEC industry code (SIC 2836) is Biological Products, (No Diagnostic Substances). Source ## Legal and investor matters Checked against Exelixis filings and press releases. Allegations are allegations; nothing here is a finding of fault. Reviewed Oct 25, 2026. The legal proceedings disclosure in the 10-Q signed 2026-08-05 (Part II, Item 1, incorporating the Commitments and Contingencies note) describes Cabometyx patent matters and says Exelixis may become party to other proceedings in the ordinary course. It does not mention a securities class action or derivative suit. This covers that filing only. [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) 1. 2026-08-31 Litigation Federal Circuit affirms ruling for Exelixis in Cabometyx patent case against MSN Exelixis said in an 8-K that the U.S. Court of Appeals for the Federal Circuit, in Appeal No. 25-1236, affirmed the Delaware District Court judgment that three Cabometyx patents are not invalid. The court dismissed as moot MSN's appeal on a fourth patent. Under the opinion, final FDA approval of MSN's generic application cannot take effect before January 15, 2030, subject to further appeals and a separate trial set for November 2026. U.S. Court of Appeals for the Federal Circuit · Case 25-1236 [Exelixis 8-K filed 2026-08-31](https://www.sec.gov/Archives/edgar/data/939767/000093976726000104/exel-20260831.htm) 2. 2026-07-06 Litigation Exelixis files patent suits against Handa and Accord over cabozantinib filings In its 10-Q for the quarter ended June 30, 2026, Exelixis reported that on July 6, 2026 it filed patent infringement complaints in the Delaware District Court against Handa Oncology, LLC and against Intas Pharmaceuticals Ltd. and Accord Healthcare, Inc. The complaints follow their filings seeking approval of cabozantinib products. The FDA granted tentative approval to Handa's application on July 29, 2026. The 10-Q says no loss estimate can be made. U.S. District Court for the District of Delaware · Status: filed [Exelixis 10-Q filed 2026-08-05](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) 3. 2025-12-30 Litigation Exelixis settles Cabometyx patent litigation with Sun Exelixis disclosed in its 10-K that it entered into a settlement agreement with Sun in December 2025. Under it, the parties terminated all pending Hatch-Waxman litigation over Cabometyx patents in the Delaware District Court. Those Sun cases were terminated on December 30, 2025, and Sun was dismissed from the consolidated litigation with trial scheduled for November 2, 2026. U.S. District Court for the District of Delaware · Status: settled [Exelixis 10-K filed 2026-02-10](https://www.sec.gov/Archives/edgar/data/939767/000093976726000021/exel-20260102.htm) 4. 2025-07-28 Litigation Exelixis settles Cabometyx patent case with Biocon, license from 2031 In its 10-Q filed July 28, 2025, Exelixis said it entered into a settlement and license agreement with Biocon in July 2025. Exelixis will license Biocon to market a generic Cabometyx in the United States beginning January 1, 2031, if approved by the FDA. The pending Delaware patent litigation is to be terminated. The 10-Q says the agreement is confidential and subject to review by the FTC and DOJ. U.S. District Court for the District of Delaware · Status: settled [Exelixis 10-Q filed 2025-07-28](https://www.sec.gov/Archives/edgar/data/939767/000093976725000113/exel-20250704.htm) 5. 2025-02-20 Financing Exelixis board authorizes additional $500 million share repurchase Exelixis said in an 8-K dated February 21, 2025 that its board authorized the repurchase of up to an additional $500 million of its common stock before December 31, 2025. The company announced the authorization on February 20, 2025 and furnished the press release as an exhibit to the filing. [Exelixis 8-K filed 2025-02-21](https://www.sec.gov/Archives/edgar/data/939767/000093976725000032/exel-20250220.htm) ## Pipeline | Program | Indication | Stage | |---|---|---| | Zanzalintinib + atezolizumab (STELLAR-303) | Previously treated metastatic colorectal cancer | NDA under FDA review; PDUFA date March 3, 2027 after a three-month extension [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) | | Zanzalintinib + nivolumab (STELLAR-304) | First-line advanced non-clear cell renal cell carcinoma | Phase 3; topline results expected in the second half of 2026 [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) | | Zanzalintinib (STELLAR-311) | Advanced neuroendocrine tumors | Phase 2/3, enrolling [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) | | Zanzalintinib +/- Keytruda Qlex (STELLAR-316) | Resected stage II/III colorectal cancer, MRD-positive | Phase 3, initiation planned mid-2026 [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) | | Cabometyx (cabozantinib) | Marketed kidney, liver, thyroid and neuroendocrine tumor indications | Marketed; $573.0 million U.S. net product revenue in Q2 2026 [Source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) | Opinion · Devil's advocate ## Fact-check-o-meter Some gaps Exelixis is mostly candid, but its zanzalintinib story leans on a trial that missed half its primary goal Exelixis's releases match its 10-Q on the numbers, and the company disclosed the FDA review extension quickly. The gaps sit in framing: the August release still pointed to a colorectal approval later this year, the missed non-liver-metastases endpoint is described as a favorable trend, and a claim about atezolizumab's contribution comes from a trial with no zanzalintinib-alone arm. The 10-Q shows a growing list of Cabometyx generic challengers, including an FDA tentative approval for Handa that the results release did not mention. 1. Press release vs filing · weight medium 'Later this year' approval became a March 2027 PDUFA date **The company said:** "advancing preparations for the potential launch of zanzalintinib in metastatic colorectal cancer, pending approval from regulatory authorities later this year." [source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) **The record says:** Five weeks later the 8-K said the FDA "had extended the review period" by three months. "In response to an FDA information request, Exelixis had submitted updated safety and efficacy data, which the FDA has deemed a major amendment. The updated Prescription Drug User Fee Act action date is March 3, 2027." [source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) **Our view:** The August wording was accurate when written, and Exelixis filed the change within a day. Still, a major amendment means the FDA asked for more data, and the 8-K does not say what the request covered. Launch timing for the company's next product has moved into 2027. 2. Science · weight high STELLAR-303 missed its second primary endpoint **The company said:** "The results showed a non-statistically significant trend in OS favoring the combination in the NLM subgroup." [source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) **The record says:** ClinicalTrials.gov lists two primary outcomes, overall survival in "All Randomized Participants" and in "Randomized Non-Liver Metastases (NLM) Participants". The 10-Q gives the NLM result as "stratified HR: 0.83" with "P=0.1185" and a confidence interval that runs from 0.66 to 1.05, against a stratified HR of 0.80 ("P=0.0045") in the full population. The registry lists the trial as open label (masking: none). [source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) **Our view:** Calling a failed primary endpoint a favorable trend is common, but the interval crosses 1, so the trial did not show a survival benefit in patients without liver metastases. The approval case rests on the intent-to-treat result alone, and how the FDA weighs the NLM miss is an open question. 3. Science · weight medium The atezolizumab contribution claim lacks a randomized comparison **The company said:** "The STELLAR-303 data support the contribution of atezolizumab to the previously observed survival benefits of zanzalintinib in combination with atezolizumab for patients with metastatic CRC." [source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) **The record says:** The registry shows two arms only: "XL092 + Atezolizumab" and "Regorafenib". There is no zanzalintinib-alone arm. The same release adds that the poster "demonstrated the importance of generating data around the potential impact of anti-drug antibodies". [source](https://clinicaltrials.gov/api/v2/studies/NCT05425940) **Our view:** Without a zanzalintinib-only arm, any estimate of what atezolizumab adds comes from post hoc or exploratory analysis, not randomization. The claim is better read as supportive analysis than as proof. 4. Legal and disclosure record · weight high MSN appeal won, but more Cabometyx challengers are lined up **The company said:** "the effective date of any final approval by the U.S. Food and Drug Administration of MSN's ANDA shall not be a date earlier than January 15, 2030" [source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000104/exel-20260831.htm) **The record says:** The 10-Q lists further cases in the U.S. District Court for the District of Delaware: a consolidated MSN and Azurity trial "scheduled for November 2, 2026", a July 6, 2026 suit against Handa, and a July 6, 2026 suit against Accord, plus a Paragraph IV notice from Almatica. It adds: "On July 29, 2026, the FDA granted tentative approval to Handa's 505(b)(2) NDA." and "It is not possible at this time to determine the likelihood of an unfavorable outcome". No securities litigation or enforcement action is disclosed in the 10-Q. [source](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) **Our view:** The Federal Circuit ruling protects against MSN until 2030, subject to the November trial on the '039 patent. The Handa tentative approval, which the August 5 results release did not mention, and the Accord and Almatica filings are separate threats to Cabometyx revenue that the MSN win does not resolve. Documents we compared - [Q2 2026 results press release (8-K exhibit 99.1)](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm) 2026-08-05 - [Form 10-Q for the quarter ended July 3, 2026](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) 2026-08-05 - [8-K: FDA extends zanzalintinib NDA review](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) 2026-09-11 - [8-K: Federal Circuit decision in Exelixis v. MSN](https://www.sec.gov/Archives/edgar/data/939767/000093976726000104/exel-20260831.htm) 2026-08-31 - [ClinicalTrials.gov NCT05425940 (STELLAR-303)](https://clinicaltrials.gov/api/v2/studies/NCT05425940) 2026-10-23 This is opinion. We compare the company's own announcements with its filings and the scientific record, and link every source. It is not an allegation of wrongdoing and not investment or legal advice. Legal items list only matters disclosed in filings or by courts and regulators. Checked Oct 23, 2026. Companies can respond through our [right of reply](https://aibio.space/reputation/#reply). ## Stock chart Price chart and quote supplied by TradingView, delayed as the exchange requires. It loads only if you choose to show it. Information only, not investment advice. [Open NASDAQ:EXEL on TradingView](https://www.tradingview.com/symbols/NASDAQ-EXEL/). ## SEC filings and registration - **SEC name**: Exelixis, Inc. - **CIK**: 939767 - **Industry (SIC)**: Biological Products, (No Diagnostic Substances) (2836) - **US tickers**: EXEL (Nasdaq) - **State or country of incorporation**: DE - **Fiscal year ends**: January 1 - **Filer category**: Large accelerated filer - **Business address**: 1851 HARBOR BAY PARKWAY, ALAMEDA, CA, 94502 - **Phone**: 6508377000 - **Shares outstanding**: 247,781,692 as of 2026-07-27 (10-Q filed 2026-08-05) - **Former names**: EXELIXIS INC ### Recent filings (8-K and 6-K are the company's own announcements) - [8-K](https://www.sec.gov/Archives/edgar/data/939767/000093976726000108/exel-20260910.htm) filed 2026-09-11 - [8-K](https://www.sec.gov/Archives/edgar/data/939767/000093976726000104/exel-20260831.htm) filed 2026-08-31 - [10-Q](https://www.sec.gov/Archives/edgar/data/939767/000093976726000098/exel-20260703.htm) filed 2026-08-05 - [8-K](https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel-20260805.htm) filed 2026-08-05 - [8-K](https://www.sec.gov/Archives/edgar/data/939767/000093976726000074/exel-20260526.htm) filed 2026-05-29 - [10-Q](https://www.sec.gov/Archives/edgar/data/939767/000093976726000059/exel-20260403.htm) filed 2026-05-05 - [8-K](https://www.sec.gov/Archives/edgar/data/939767/000093976726000058/exel-20260505.htm) filed 2026-05-05 - [DEF 14A](https://www.sec.gov/Archives/edgar/data/939767/000093976726000046/exel-20260415.htm) filed 2026-04-15 Source: [SEC EDGAR](https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000939767), retrieved October 23, 2026. Shares outstanding is the cover-page figure from the latest periodic report. The SEC does not publish share prices. Who manages this page **This page is managed by aibio.space.** The company does not run, edit or pay for this page. News, desk views and Investor Ranks are written and managed independently by aibio.space under our editorial and analytical judgment. Opinion only, not investment advice. [How we work](https://aibio.space/disclosures/#paid) · [Terms](https://aibio.space/terms/#news) · [Request a correction](https://aibio.space/reputation/#update) --- Source page: https://aibio.space/companies/exelixis/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Exelixis (EXEL) news: buyback", 2026-10-31, https://aibio.space/companies/exelixis/