Shares of Exelixis, Inc. EXEL have rallied 15.2% in the year so far, while the performance of the industry remained flat.
Exelixis’ lead drug Cabometyx (a tablet formulation of cabozantinib), which was approved in the United States in April 2016 for the treatment of patients with advanced renal cell carcinoma (RCC), who have received prior anti-angiogenic therapy, continues to maintain momentum despite competition.
The company also expanded the drug’s label for the treatment of previously-untreated advanced RCC in December 2017. Cabometyx received another FDA approval for the treatment of patients with hepatocellular carcinoma (HCC) in January 2019.
Cabometyx generated $189 million of net product revenues in the second quarter of 2019. The drug gained market share throughout the second quarter for the RCC indication. The initial traction for the HCC indication in the second and third-line settings was encouraging as well. In the recently reported quarter, patient demand rose 26% year over year and 9% sequentially, driven by both RCC and HCC. Prescriber base grew 45%.
The company ended the quarter with 34% market share, backed by its broad label for advanced RCC. The company's stellar performance in the first half of 2019 has created a solid platform for growth in the second half as well.
Concurrently, Exelixis is working to expand the drug’s label further. It has collaboration agreements with Bristol-Myers Squibb BMY and Roche RHHBY to evaluate cabozantinib in combination with immunotherapy agents.
In May, CheckMate 9ER, the phase III trial evaluating the combination of cabozantinib and Opdivo versus Pfizer’s PFE Sutent in patients with previously-untreated advanced or metastatic RCC, completed enrollment. The study was sponsored by Bristol-Myers Squibb Company (BMY) and co-funded by Exelixis, and partners Ipsen and Takeda. Results are expected by early 2020. Exelixis also initiated a multi-center, randomized, double-blinded, controlled phase III study, COSMIC-313, to evaluate Cabometyx in combination with Opdivo and Yervoy versus Opdivo and Yervoy in patients with previously-untreated advanced RCC.
Meanwhile, the company made amendments to its multi-center, open-label, phase Ib study, COSMIC-021, evaluating Cabometyx in combination with Roche’s Tecentriq in patients with locally-advanced or metastatic solid tumors.
Exelixis is looking to strengthen its pipeline as well. It inked an exclusive option and license agreement with Aurigene, a biotechnology company from India focusing on oncology and inflammatory disorders, to in-license up to six oncology programs from the latter. Per the terms, Exelixis will make an upfront payment of $10.0 million for exclusive options to license three pre-existing programs.
Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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