Onyx shares rose 12% to $76.47 in late Friday trading.
Kyprolis will be used to treat patients with multiple myeloma that is no longer responding to other therapies, including Celgene's (CELG) Revlimid or Thalomid and Takeda's Velcade.
Onyx will be ready to launch the drug on Aug. 1. One 28-day treatment cycle of Kyprolis therapy will cost $9,950, higher than what the Street was expecting. Patients in the Kyprolis clinical trial were on drug about 4.4 months, Onyx said."The approval of Kyprolis provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies," said FDA's cancer drug chief Richard Pazdur, in a statement. "We are encouraged by the continued progress in the development of drugs for multiple myeloma over the past decade, offering improved treatment of this disease." "Today's approval is a significant milestone for Onyx and, most importantly, for patients with advanced myeloma who have few treatment options available to them," said Onyx CEO Tony Coles, in a statement. Ligand Pharmaceuticals (LGND) will receive a royalty on Kyprolis sales. Ligand shares were down 11 cents to $17.42 in recent trading. --Written by Adam Feuerstein in Boston.
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