Exelixis Inc Stock Price, News & Analysis

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.

Sairopa B.V. has achieved a significant milestone in its partnership with Exelixis (NASDAQ: EXEL) regarding ADU-1805, an anti-SIRPα antibody for cancer treatment. The collaboration has generated substantial payments, including a $40 million upfront payment, $35 million for IND clearance, and an additional $35 million in clinical development milestones. The agreement grants Exelixis an exclusive option for worldwide development and commercialization rights following phase 1 clinical studies data review.

ADU-1805 is currently in a first-in-human phase 1 study across the U.S. and Europe, evaluating both monotherapy and combination treatment with pembrolizumab. The partnership combines Exelixis' oncology expertise with Sairopa's immunotherapy capabilities.