Exelixis Inc Stock Price, News & Analysis

Exelixis (NASDAQ:EXEL) announced that its partner Ipsen has received European Commission approval for CABOMETYX® (cabozantinib) to treat adult patients with advanced neuroendocrine tumors (NET) who have progressed after prior therapy. The approval is based on the successful phase 3 CABINET trial and covers all 27 EU member states, Norway, Liechtenstein, and Iceland.

CABOMETYX becomes the first and only systemic therapy approved in the EU for previously treated NET, regardless of tumor site, grade, or previous non-somatostatin analogue-based therapy. This milestone follows the drug's U.S. FDA approval in March 2025 for similar indications in both adult and pediatric patients aged 12 and older.

Exelixis (Nasdaq: EXEL) has scheduled the release of its second quarter 2025 financial results for Monday, July 28, 2025, after market close. The company 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.

Interested parties can access the event through pre-registration to obtain dial-in details, or via webcast through the company's website. A replay of the webcast will be available on www.exelixis.com for one year.

Exelixis (NASDAQ: EXEL) reported positive topline results from the STELLAR-303 phase 3 pivotal trial, showing that zanzalintinib combined with atezolizumab significantly improved overall survival compared to regorafenib in patients with previously treated non-MSI-high metastatic colorectal cancer. The trial met one of its dual primary endpoints in the intent-to-treat population and will continue to analyze overall survival in patients without liver metastases. The safety profile of the combination therapy remained consistent with previous observations, with no new safety concerns identified. The study will evaluate secondary endpoints including progression-free survival, objective response rate, and duration of response.

Exelixis announced that its partner Ipsen received a positive CHMP opinion for CABOMETYX (cabozantinib) to treat adult patients with advanced neuroendocrine tumors (NET) who have progressed after prior therapy. The recommendation covers both extra-pancreatic (epNET) and pancreatic (pNET) tumors. This follows the FDA's March 2025 approval of CABOMETYX for similar indications in the US, including patients 12 years and older. The CHMP recommendation is based on the phase 3 CABINET trial results, which evaluated CABOMETYX against placebo in previously treated NET patients. The European Commission will review the recommendation, with a final decision expected in the coming months.

Exelixis (NASDAQ: EXEL) reported promising results from its phase 1b/2 STELLAR-002 trial evaluating zanzalintinib combinations for advanced kidney cancer. The study tested zanzalintinib with nivolumab (n=40) and with nivolumab-relatlimab (n=40) in previously untreated advanced clear cell RCC patients. Key findings include:

The nivolumab combination showed a 63% objective response rate and 90% disease control rate. At median follow-up of 20.1 months, the 12-month duration of response was 73.4%, with median progression-free survival of 18.5 months.

The nivolumab-relatlimab combination demonstrated a 40% objective response rate and 90% disease control rate. At 15.9 months follow-up, the 12-month duration of response was 74.1%, with median progression-free survival of 13.0 months.

While treatment-emergent adverse events occurred in all patients, the safety profile was manageable. The 100mg dose of zanzalintinib was selected for ongoing expansion cohorts based on preliminary results.

Exelixis (NASDAQ: EXEL) has announced its participation in three upcoming investor conferences in May and June 2025. The company will participate in fireside chats at the TD Cowen 6th Annual Oncology Innovation Summit (May 27), the William Blair 45th Annual Growth Stock Conference (June 3), and the Jefferies Global Healthcare Conference 2025 (June 4).

All presentations will be accessible via webcast on www.exelixis.com under the Investors & News section's Event Calendar page. Replay recordings will remain available for at least 30 days after the events.

Exelixis (NASDAQ: EXEL) has initiated the dose-escalation stage of a Phase 1 clinical trial for XB628, a first-in-class bispecific antibody, in patients with recurrent advanced or metastatic solid tumors. The drug candidate was developed in collaboration with Invenra Inc., targeting NK group 2 member A (NKG2A) and programmed cell death-ligand 1 (PD-L1). XB628 functions as a natural killer (NK) cell engager, representing a novel approach in cancer immunotherapy.

Exelixis (NASDAQ: EXEL) reported strong Q1 2025 financial results with total revenues of $555.4M, up from $425.2M in Q1 2024. The company's CABOMETYX franchise generated $513.3M in U.S. net product revenues. GAAP diluted EPS reached $0.55, while non-GAAP diluted EPS was $0.62. Following strong performance, Exelixis increased its 2025 guidance by $100M for both net product revenues and total revenues. Key highlights include FDA approval for CABOMETYX in advanced neuroendocrine tumors (NET) and promising developments in the zanzalintinib pipeline. The company continues its stock repurchase program, having bought back $494.5M worth of shares at an average price of $34.87 per share.

Exelixis (NASDAQ: EXEL) has announced its participation in two major investor conferences in May 2025. The company will be featured in fireside chats at the BofA Securities 2025 Health Care Conference in Las Vegas on May 14 at 1:40 p.m. ET, and at the RBC Capital Markets 2025 Global Healthcare Conference in New York City on May 20 at 10:30 a.m. ET.

Interested parties can access the webcasts through the Event Calendar page on www.exelixis.com under the Investors & News section. Replay recordings will remain available on the website for a minimum of 30 days after the events.