Bristol Myers Squibb (BMY) and partner Exelixis (EXEL) announced that the U.S. Food and Drug Administration accepted their application and granted priority review for their treatment of a form of advanced kidney cancer. BMY stock and EXEL stock both climbed in premarket trading.


Early Monday, the companies said the FDA accepted their supplemental biologics license application and new drug application for BMY’s Opdivo in combination with EXEL’s Cabometyx for patients with advanced renal cell carcinoma. They said the FDA granted priority review and set a target action date of Feb. 20.

Renal cell carcinoma is the most common type of kidney cancer in adults and accounts for more than 140,000 deaths worldwide each year, the companies said in their announcement. Men are twice as likely as women to get this cancer. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%, the companies said.

The companies said their final-phase clinical trials shows significant improvements in survival rates and progression-free survival vs. the current standard drug therapy sunitinib, made by Pfizer (PFE) under the brand name Sutent.

The cancer therapy Opdivo is Bristol Myers Squibb’s No. 3 drug, behind Revlimid and Eliquis. For the second quarter, BMY reported Opdivo sales of $1.65 billion.

BMY Stock, EXEL Stock Sport High Composite Ratings

On the news, BMY stock rose 1% in premarket trading in the stock market today, near 61.60. BMY stock has flirted with its 50-day and 200-day lines the past three months. Shares have formed a long consolidation, with a possible buy point of 67.90.

Meanwhile, EXEL stock jumped more than 3% in premarket to 24. EXEL stock has a possible buy point of 27.90 out of a consolidation. Shares hit a 32-month of 27.80 in May.

Both BMY stock and EXEL are among top performers, with respective Composite Ratings of 88 and 86. That puts them among the top 14% of all stocks based on a range of key technical and fundamental factors.

Follow Michael Krey on Twitter at @MichaelKrey.


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