Exelixis Inc Stock Price, News & Analysis

Exelixis (NASDAQ: EXEL) reported detailed Phase 3 STELLAR-303 results for zanzalintinib + atezolizumab in previously treated non‑MSI‑high metastatic colorectal cancer presented at ESMO 2025 and published in The Lancet. In the ITT population the combination reduced risk of death by 20% (stratified HR 0.80; 95% CI 0.69–0.93; P=0.0045) with median OS 10.9 months versus 9.4 months for regorafenib at 18.0‑month follow‑up. PFS trended favorably (HR 0.68; median 3.7 vs 2.0 months). Safety showed higher grade 3/4 AEs (59% vs 37%) and modestly higher discontinuations. Exelixis plans a U.S. NDA submission in 2025.

Exelixis (NASDAQ: EXEL) reported subgroup results from the CABINET phase 3 trial showing CABOMETYX (cabozantinib) markedly improved outcomes in previously treated advanced lung or thymic neuroendocrine tumors (NET).

In 49 patients with lung or thymic NET, CABOMETYX reduced risk of progression or death by 81% vs placebo (HR 0.19; 95% CI 0.06-0.54; one-sided P=0.0003) with median PFS 8.2 months vs 2.7 months. Confirmed objective response rates were 6% vs 0%. Safety was consistent with known profile; most frequent grade 3/4 events: fatigue 24%, hypertension 18%, diarrhea 9%, palmar plantar erythrodysesthesia 9%.

U.S. FDA approvals in March 2025 and European Commission approval in July 2025 were noted.

Exelixis (Nasdaq: EXEL) has appointed Dana T. Aftab, Ph.D. as Executive Vice President, Research and Development. Dr. Aftab, a 25-year veteran of the company, will oversee all aspects of drug discovery, translational research, product development, and medical affairs activities.

Dr. Aftab has been instrumental in the discovery and development of CABOMETYX® (cabozantinib), the leading tyrosine kinase inhibitor in the U.S. for advanced renal cell carcinoma and advanced neuroendocrine tumors. Previously serving as Executive Vice President, Discovery and Translational Research and Chief Scientific Officer since December 2022, he will now lead the development of zanzalintinib and the company's early-stage pipeline.

Exelixis (Nasdaq: EXEL) announced its participation in five major investor conferences during September 2025. The company will present at the Wells Fargo Healthcare Conference, Citi's Biopharma Back to School Conference, Morgan Stanley Global Healthcare Conference, H.C. Wainwright Global Investment Conference, and Bernstein's Healthcare Forum.

All presentations will be accessible via webcast on the company's website, with replays available for at least 30 days following each event. The conferences are scheduled between September 3-24, 2025, with events taking place in various locations including Boston, New York City, and Everett, MA.

Exelixis (Nasdaq: EXEL) reported strong Q2 2025 financial results with total revenues of $568.3 million, including $520.0 million in Cabozantinib franchise U.S. net product revenues. The company achieved GAAP diluted EPS of $0.65 and Non-GAAP diluted EPS of $0.75.

Key highlights include positive reception of CABOMETYX in advanced neuroendocrine tumors (NET) following March approval, positive topline results from STELLAR-303 pivotal study in colorectal cancer, and completion of STELLAR-304 enrollment in non-clear cell renal cell carcinoma. The company maintains its 2025 guidance with projected total revenues of $2.25-2.35 billion.

The pipeline is advancing with ongoing Phase 1 studies for XL309, XB010, and XB628 programs, while XB371 is moving into clinical investigation. The company has discontinued the STELLAR-305 study in head and neck cancer and plans to announce additional zanzalintinib pivotal trials.

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.