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Wednesday, May 18, 2022

FDA to Consider Additional Use for Amgen Bone Drug

Shares of Amgen Inc. hit a 52-week high Friday morning following the biotech’s announcement that the U.S. Food and Drug Administration advisory committee would consider a new use for the bone drug Xgeva.

The Thousand Oaks company late Thursday said the FDA’s Oncologic Drugs Advisory Committee would meet Feb. 8 to consider approving Xgeva for the treatment of men with some forms of prostate cancer who are at high risk of having their cancer spread to their bones. The FDA is scheduled to make a final decision by April 26.

Approval could significantly boost Xgeva sales, since it would become the first therapy for the prevention or delay of bone cancer, also called metastases, in prostate cancer patients.

Xgeva already is approved to help prevent fractures in cancer patients whose solid tumors have spread to the bone. The drug, whose generic name is denosumab, also is marketed under the trade name Prolia as an osteoporosis treatment.

Amgen shares have risen 17 percent since the beginning of the year. Prior to the Xgeva announcement, equity analysts at Bank of America raised their 12-month price target on the stock $65 on Thursday, and Citigroup analysts earlier this week raised their target to $73.

After earlier trading at a 52-week high of $64.98, Amgen shares were up 19 cents, or less than 1 percent, to $64.93 in Friday midday trading on the Nasdaq.

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