Exelixis, Inc. (EXEL - Free Report) and partner Ipsen Biopharmaceuticals received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for the label expansion of Cabometyx (cabozantinib) tablets. The company is seeking approval for Cabometyx tablets as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults, who have been previously treated with Bayer’s (BAYRY - Free Report) Nexavar (sorafenib).
We note that Cabometyx is already approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC), who have received prior anti-angiogenic therapy. It is also approved in Europe for the first-line treatment of adults with intermediate- or poor-risk advanced RCC in the European Union.
The CHMP opinion is supported by data from the phase III CELESTIAL study of Cabometyx in patients with advanced HCC, who received Nexavar previously. In this study Cabometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) against placebo.
Per the collaboration agreement with Ipsen, Exelixis is eligible to receive a milestone payment of $40 million for the approval of the second-line treatment of HCC. This milestone would be paid by Ipsen within 70 days of the European Commission’s approval decision.
Shares of Exelixis decreased 44.9% year to date compared with the industry’s decline of 3.9%.
In September 2018, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include new recommendations for Cabometyx. Following the update, Cabometyx is now recommended by the NCCN for treating advanced RCC, regardless of patient risk status (favorable-, intermediate- and poor-risk).
Moreover, the NCCN in its recent update on the Clinical Practice Guidelines for Hepatobiliary Cancers added Cabometyx as a Category 1 option for the treatment of patients with HCC (Child-Pugh Class A only), who have been previously administered with Nexavar.
However, the drug is not yet approved for this indication. In May 2018, the FDA accepted the supplemental new drug application for Cabometyx in previously treated advanced HCC and assigned it with a Prescription Drug User Fee Act action date of Jan 14, 2019.
We remind investors that last week, the company along with Ipsen also received an approval for Cabometyx tablets in Canada, for the treatment of advanced RCC in adult patients, who have been previously treated with vascular endothelial growth factor targeted therapy.
Cabometyx generated $270 million of net product revenues in the first half of 2018. The company experienced a 14% increase in the drug’s prescriber base during the second quarter of 2018 as compared to the first. Cabometyx sales are expected to rise further this year as the drug is now approved for first-line RCC. This will expand the eligible patient population in the United States.
Zacks Rank & Stocks to Consider
Exelixis is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD - Free Report) and Ligand Pharmaceuticals Inc. (LGND - Free Report) . Both of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.54 to $6.58 for 2018 and from over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 4.5% so far this year.
Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 89.8% year to date.
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