Exelixis Halt STELLAR-305 Trial, Focusing on CABOMETYX Growth

Exelixis, Inc. (EXEL) has halted its Phase 3 STELLAR-305 trial for squamous cell carcinoma, focusing on more commercially promising opportunities. The biotechnology company's growth is driven by its flagship product CABOMETYX and a promising oncology pipeline. Despite a modest stock decline in Q2 2025, Exelixis remains committed to pipeline development, ongoing studies for XL309, XB010, and XB628, and FDA clearance for an IND application for XB371. Collaborative partnerships, particularly with Bristol-Myers Squibb, support market leadership and strategic growth.

Exelixis, Inc. (EXEL) has announced the halting of its Phase 3 STELLAR-305 trial for squamous cell carcinoma, refocusing on more commercially promising opportunities. The biotechnology company's growth is driven by its flagship product, CABOMETYX, and a promising oncology pipeline. Despite a modest stock decline in Q2 2025, Exelixis remains committed to pipeline development and ongoing studies for XL309, XB010, and XB628, as well as FDA clearance for an IND application for XB371. Collaborative partnerships, particularly with Bristol-Myers Squibb, support market leadership and strategic growth.

CABOMETYX, a multi-targeted tyrosine kinase inhibitor, has seen significant advancements recently. In February 2025, the U.S. FDA approved CABOMETYX for previously treated advanced neuroendocrine tumors (NET), including pancreatic and extra-pancreatic NETs [1]. This approval, based on the phase 3 CABINET trial, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo. CABOMETYX is now the first and only systemic treatment approved for previously treated NETs regardless of primary tumor site, grade, somatostatin receptor expression, and functional status.

The company's strategic shift comes as Exelixis continues to invest in its pipeline, with ongoing studies and collaborations. In 2024, the National Comprehensive Cancer Network (NCCN) updated its guidelines to include cabozantinib as a preferred regimen for advanced NETs, reflecting its clinical efficacy and potential to improve patient outcomes [1].

Exelixis' commitment to pipeline development and strategic partnerships positions it as a leader in the oncology market. Despite the setback with the STELLAR-305 trial, the company's focus on CABOMETYX and other promising therapies indicates a long-term strategy to grow and diversify its revenue streams.

References:
[1] https://www.businesswire.com/news/home/20250219147539/en/Exelixis-Announces-U.S.-FDA-Approval-of-CABOMETYX-cabozantinib-for-Patients-with-Previously-Treated-Advanced-Neuroendocrine-Tumors