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Shares of Exelixis, Inc. EXEL have surged 50% in a year against the industry’s decline of 16.1%. The stock has also outperformed the sector and the S&P 500 Index in this timeframe.
The company's stellar performance can be attributed to the strong growth of its lead drug, Cabometyx, raised guidance and encouraging pipeline progress.
EXEL Outperforms Industry, Sector & S&P 500
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Cabometyx Boosts EXEL
Cabometyx maintained its status as the leading tyrosine kinase inhibitor (TKI) for the treatment of renal cell carcinoma (RCC) in 2024. This was mainly due to its use in combination with Bristol Myers’ BMY Opdivo in the first-line setting. The drug also maintained growth in the hepatocellular carcinoma indication.
BMY’s Opdivo is one of the leading immuno-oncology drugs, approved for various oncology indications.
Management is also focused on the label expansion of Cabometyx. The FDA accepted EXEL’s supplemental new drug application (sNDA) for cabozantinib for patients with previously treated advanced pancreatic neuroendocrine tumors (pNET) and those with previously treated advanced extra-pancreatic NET (epNET). The FDA assigned a standard review with a target action date of April 3, 2025. The FDA also granted the orphan drug designation to cabozantinib for the treatment of pNET.
The FDA recently notified the company that the sNDA for cabozantinib for the treatment of adults with previously treated advanced pNET and advanced epNET will be discussed at an Oncologic Drugs Advisory Committee meeting in March 2025.
A potential label expansion should further propel its growth prospects.
Exelixis also intends to submit an sNDA with the FDA for cabozantinib, in combination with Tecentriq (atezolizumab), for metastatic castration-resistant prostate cancer.
EXEL Raises 2024 Revenue Guidance
While reporting third-quarter results in October 2024, the company raised its annual revenue gudiance. Total revenues are projected to be between $2.150 billion and $2.2 billion (previous guidance: $1.975-$2.075 billion). Product revenues are estimated to be in the band of $1.775-$1.825 billion (previous guidance: $1.65-$1.75 billion).
EXEL Strives to Develop Other Pipeline Candidates
The pipeline progress has also been impressive as Exelixis looks to expand its oncology portfolio beyond Cabometyx.
Another promising candidate in Exelixis’ pipeline is zanzalintinib, a next-generation oral TKI. Enrollment has been completed in the late-stage STELLAR-303 study evaluating zanzalintinib, in combination with Tecentriq, compared with regorafenib in patients with metastatic refractory colorectal cancer that is not microsatellite instability-high or mismatch repair-deficient. Preliminary results from the study are expected in 2025.