Welcome to our dedicated page for Exelixis news (Ticker: EXEL), a resource for investors and traders seeking the latest updates and insights on Exelixis stock.
Exelixis Inc. (symbol: EXEL) is a leading biopharmaceutical company that specializes in the discovery, development, and commercialization of small molecule therapies aimed at improving cancer treatment. Founded in the early 1990s, Exelixis has dedicated the past decade to establishing a robust development platform to bring new, effective cancer therapies to patients in need.
Exelixis’s flagship product, Cometriq® (cabozantinib), received its initial regulatory approval in late 2012 and has since been a cornerstone in the company’s portfolio. Cometriq is prescribed for the treatment of metastatic medullary thyroid cancer, while its variant Cabometyx is used for treating kidney and liver cancers.
Another significant achievement is the development and commercialization of Cotellic in partnership with Roche, targeted at melanoma treatment. These therapies have not only enhanced Exelixis’s market presence but also brought substantial improvements in patient outcomes.
Exelixis remains steadfast in its commitment to clinical excellence and patient care, consistently exploring new avenues for innovative cancer treatments. The company continues to engage in rigorous research and development activities, underpinned by strategic partnerships and collaborations.
Financially, Exelixis has shown solid performance with steady revenue growth driven by its commercial products and a promising pipeline of new therapies under development. The company’s dedication to research, patient care, and financial prudence makes it a notable entity in the biopharmaceutical landscape.
For more information about Exelixis and potential job opportunities, please visit their official website at www.exelixis.com.
Exelixis (NASDAQ: EXEL) has announced a new $500 million stock repurchase program authorized by its Board of Directors, to be completed by December 31, 2025. The company plans to initiate this program after completing its current $500 million repurchase program, which is expected to conclude in Q2 2025.
This marks Exelixis' fourth stock repurchase program since March 2023, with the company having already returned over $1.2 billion to shareholders through these initiatives as of the end of fiscal year 2024. The repurchases may be executed through various methods, including open market purchases, block trades, and accelerated share repurchase transactions. The timing and volume of repurchases will be determined by factors including capital needs, alternative investments, stock price, and market conditions.
Exelixis (EXEL) announced final five-year follow-up results from the CheckMate -9ER trial evaluating CABOMETYX combined with Opdivo versus sunitinib in advanced kidney cancer patients. After 67.6 months median follow-up, the combination showed improved progression-free survival (PFS; HR: 0.58) and overall survival (OS; HR: 0.79) compared to sunitinib.
Key findings include median PFS of 16.4 vs 8.3 months and median OS of 46.5 vs 35.5 months for the combination vs sunitinib, respectively. The objective response rate was 55.7% for the combination versus 27.4% for sunitinib. The efficacy benefits were observed across different patient subgroups, including those with organ metastases and different risk classifications.
Safety profile remained manageable with no new safety signals reported, though Grade 3/4 adverse events were higher in the combination group (68%) versus sunitinib (55%).
Exelixis (NASDAQ: EXEL) has announced its participation in the upcoming Citi 2025 Virtual Oncology Leadership Summit. The company's management will engage in a fireside chat scheduled for Wednesday, February 19 at 2:00 p.m. ET / 11:00 a.m. PT.
The presentation will be accessible via webcast on www.exelixis.com under the Investors & News section's Event Calendar page. For those unable to attend live, a replay of the session will remain available on the same platform for a minimum of 30 days following the event.
Exelixis (EXEL) reported strong financial results for Q4 and FY 2024. Total revenues reached $567M for Q4 and $2.17B for FY 2024. The cabozantinib franchise achieved $1.81B in U.S. net product revenues for FY 2024, including $515M in Q4.
Key financial metrics include GAAP diluted EPS of $0.48 for Q4 and $1.76 for FY 2024, while non-GAAP diluted EPS was $0.55 and $2.00 respectively. The company maintains its 2025 guidance with total revenues projected at $2.15B-$2.25B.
Notable developments include a pending FDA decision for CABOMETYX in advanced neuroendocrine tumors with a PDUFA date of April 3, 2025, and anticipated zanzalintinib pivotal data milestones in 2025. The company also continues its stock repurchase program, having bought back $205.6M of common stock at an average price of $33.62 per share.
Exelixis (NASDAQ: EXEL) has announced it will release its fourth quarter and full year 2024 financial results on Tuesday, February 11, 2025, after market close. The company's management will host a conference call and webcast at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and provide a business update.
Investors can access the conference call by registering through a provided link, which will generate a unique PIN and dial-in number. The webcast will be available on the company's website under the Investors & News section's Event Calendar page, with a replay accessible for one year.
Exelixis (NASDAQ: EXEL) has released results from the phase 1b/2 STELLAR-001 trial evaluating zanzalintinib alone or combined with atezolizumab in previously-treated metastatic colorectal cancer patients. The study included 107 patients randomized 1:1, with median prior therapy lines of 3.0 and 2.5 respectively.
Key findings show improved progression-free survival (PFS) and overall survival (OS) when combining the treatments, particularly in patients without liver metastases. In this subgroup, median PFS increased from 3.3 to 8.2 months, and the 6-month survival rate reached 87.8% for the combination versus 64.7% for zanzalintinib alone.
Regarding safety, Grade 3/4 treatment-related adverse events occurred in 40% of patients on zanzalintinib alone and 48% on the combination therapy. Common side effects included nausea, diarrhea, fatigue, and hypertension. The company expects data from the related STELLAR-303 trial in the second half of 2025.
Exelixis (NASDAQ: EXEL) has announced positive results from a subgroup analysis of the phase 3 CABINET study evaluating cabozantinib in patients with gastrointestinal neuroendocrine tumors (GI NET). The analysis showed that cabozantinib reduced the risk of disease progression or death by 50% compared to placebo.
The study included 116 patients, with primary tumor locations predominantly in the ileum/cecum (54%) and small intestine (20%). Median progression-free survival was 8.5 months with cabozantinib versus 5.6 months with placebo. One patient achieved partial response with cabozantinib, while 48 patients achieved stable disease compared to 30 with placebo.
The FDA is currently reviewing Exelixis's supplemental New Drug Application for cabozantinib in advanced neuroendocrine tumors, with a target action date of April 3, 2025. Common grade 3/4 adverse events included hypertension (19%), diarrhea (13%), and fatigue (10%).
Exelixis (NASDAQ: EXEL) has announced preliminary fiscal year 2024 results and 2025 guidance. The company achieved approximately $1.805 billion in preliminary U.S. net product revenues for FY2024 from its cabozantinib franchise, with total revenues reaching ~$2.165 billion.
For FY2025, Exelixis projects net product revenues between $1.95-$2.05 billion and total revenues of $2.15-$2.25 billion. The guidance includes a 2.8% price increase for CABOMETYX effective January 2025 but excludes potential revenues from NET indication pending FDA approval.
The company expects key developments in 2025, including a potential FDA approval for CABOMETYX in neuroendocrine tumors (NET) with a PDUFA date of April 3, 2025, and multiple data readouts for zanzalintinib. R&D expenses are projected at $925-975 million for 2025, with SG&A expenses estimated at $475-525 million.
Exelixis (EXEL) announced that the FDA has removed the supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) from discussion at an upcoming Oncologic Drugs Advisory Committee meeting. The sNDA seeks approval for treating previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET) in adults. The FDA continues to review the application with a Prescription Drug User Fee Act action date of April 3, 2025.
Exelixis (NASDAQ: EXEL) has announced its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference. The company's President and CEO, Michael M. Morrissey, Ph.D., will deliver a corporate overview presentation on Monday, January 13, 2025, at 5:15 p.m. PT / 8:15 p.m. PT.
The presentation will be accessible via webcast through the company's website at www.exelixis.com, specifically on the Event Calendar page under the Investors & News section. For those unable to attend live, replay access will remain available on the same platform for a minimum of 30 days following the presentation.
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