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Thursday, Nov 30, 2023

Update: Amgen Announces Trial Setback, Recall

Shares of Thousand Oaks pharmaceuticals firm Amgen Inc. rebounded Thursday following a double dose of bad news the day before in the form of a trial setback and a recall. The company disclosed that Phase III trials for the myeloma treatment Kypolis did not show the drug led to superior survival rates among patients with relapses or who did not respond to previous treatments. Myeloma cancer affects the plasma cells. The drug 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. Amgen separately announced a voluntary recall outside the United States of nine lots of prefilled syringes of Aranesp after a quality check found signs of foreign materials in the products. Aranesp is used for the treatment of anemia associated with kidney failure and the recalled products were not known to be blamed for any health problems at the time of Amgen’s disclosure. Aranesp’s sales totaled about $490 million last year. News of the setbacks sent Amgen shares down 2 percent in after-hours trading on Wednesday, but on Thursday the stock closed up $4.52, or 3.5 percent, to $131.86 on the New York Stock Exchange. Piper Jaffray’s analyst Joshua Schimmer told Barron’s that the 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. Onyx Pharmaceuticals President Pablo J. Cagnoni noted in an Amgen press release that a Kypolis trial earlier this month showed positive results for patients in early stages of the disease, a result that “ will be sufficient to support regulatory submissions around the world.”

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