Amgen Releases Results; FDA Approves XGEVA

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Amgen Inc. has released detailed positive results from a study on cancer treatment Kyprolis, a key drug for the biopharmaceutical company that disappointed investors with earlier trial results.

New data from the Thousand Oaks company show the drug met expectations for patient survival rate, overall response rate and health-related quality of life measures for patients suffering from myeloma, a cancer of plasma blood cells.

In August, the company announced that the Phase 3 study showed patients with multiple myeloma who used Kyprolis did not have a longer lifespan than patients using treatments currently on the market.

However, at the time, Piper Jaffray’s analyst Joshua Schimmer said concerns about Kypolis were overstated given other positive trial results for the drug. “There is a risk in over-interpreting the implications of a missed trial,” he said.

Kyprolis was acquired by Amgen last year when it paid $10.4 billion for Onyx Pharmaceuticals in South San Francisco. With many of Amgen’s legacy drugs expected to face stiff competition from so-called “biosimilar” versions by rival firms, analysts have said Kyprolis is important to the company’s growth.

Also on Monday, the Food and Drug Administration approved a new use for XGEVA, an Amgen drug for bone cancer. The FDA approval means XGEVA can be used for hypercalcemia of malignancy, a lack of calcium in the blood caused by certain cancers.

Amgen shares closed up 42.40 or 1.4 percent to $171.64 on the Nasdaq.

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