Core Insights - Exelixis' lead drug, Cabometyx, has received FDA approval for label expansion to treat adult and pediatric patients aged 12 and older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (NET) in March 2025, marking a significant advancement for the company [1][10] Product Overview - Cabometyx is the first and only systemic treatment FDA approved for previously treated NET, applicable regardless of primary tumor site, grade, somatostatin receptor expression, and functional status [2] - The drug is noted as the first broadly applicable new oral small molecule therapy for NET in nine years [2] Market Demand and Performance - Initial uptake for Cabometyx's new indication is strong, capturing 35% of the new patient share for oral therapies in this indication, with demand just over 4% of total demand for cabozantinib in Q2 [3][10] - Exelixis expects Cabometyx to be widely used across various patient and tumor characteristics, including those with NET from the pancreas, GI tract, and lung [5] Regulatory Approvals - In July, Exelixis announced that its partner Ipsen received regulatory approval for Cabometyx for adult patients with unresectable or metastatic well-differentiated extra-pancreatic and pancreatic NET in the EU [4] Competitive Landscape - Cabometyx faces competition from Novartis' Lutathera, which is also used for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [6] - In the renal cell carcinoma (RCC) space, Cabometyx competes with Merck's Keytruda and Inlyta, as well as Merck's Welireg [7][8] Financial Performance - Exelixis shares have gained 13.8% year-to-date, outperforming the industry growth of 4% [9][10] - The company's valuation is considered high, with a price/sales ratio of 4.07x forward sales, above its mean of 3.64x and the biotech industry's 1.58x [11] Earnings Estimates - The bottom-line estimate for 2025 has increased from $2.65 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.08 over the past 30 days [12]