Shares of Exelixis Inc. (EXEL) jumped 22.1% to $30.24 in morning trading on Monday, Oct. 16, after the South San Francisco, Calif.-based firm said its Phase 3 study of cabozantinib achieved its primary endpoint of overall survival in patients that have advanced hepatocellular carcinoma. Exelixis said plans to submit a supplemental new drug application to the U.S. Food and Drug Administration in the first quarter of next year.
The FDA approved Cabometyx in April 2016 for patients with advanced RCC that have received prior anti-angiogenic therapy.
Also on Monday, Exelixis said the FDA has granted priority review for its supplemental new drug application for Cabometyx (cabozantinib) for patients with previously untreated advanced renal cell carcinoma. The agency gave a Prescription Drug User Fee Act (PDUFA) action date of Feb. 15, 2018. The PDUFA date is the date by which the FDA plans to complete its review of the application.
Meanwhile, shares of Aratana Therapeutics Inc. (PETX) were up 9.1% to $6.82 after the Leawood, Kan.-based firm on Friday said it was making Entyce available to veterinarians to stimulate appetite in dogs.
Among the other biotech stock movers was Cara Therapeutics Inc. (CARA) . Shares rose nearly 8% to $13.44 after the Stamford, Conn.-based firm said it has recently completed its end-of-Phase 2 meeting with the FDA for I.V. CR845 in chronic kidney disease-associated pruritus in hemodialysis patients.
"We expect to initiate our pivotal Phase 3 program of I.V. CR845 for the treatment of CKD-aP in hemodialysis patients in the U.S. by the end of 2017, and will continue working closely with the agency to develop CR845 as a potential new therapeutic option for this highly debilitating aspect of CKD as quickly as possible," said Cara president and CEO Derek Chalmers in a statement.