Japanese Distributor Halts Amgen Drug Prescriptions After 20 Deaths
AMGN sits 24% above its 52-week low of $264.15.
Summary
Kissei Pharmaceutical, Amgen's licensee in Japan, has instructed doctors to stop prescribing the rare-disease drug Tavneos to new patients following reports of 20 deaths and 22 serious liver injuries, with 13 deaths attributed to vanishing bile duct syndrome. This development escalates prior regulatory concerns; the FDA had already requested Amgen voluntarily pull the drug from the U.S. market in January, identified 76 global cases of serious liver injury (including 8 deaths) in March, and initiated formal withdrawal proceedings in late April. While Tavneos generated $119 million in Q1 sales, representing less than 2% of Amgen's total revenue, the explicit death count, immediate market action in Japan, and ongoing FDA withdrawal process pose significant reputational damage and potential legal liabilities for Amgen. This also casts a shadow on the $3.7 billion acquisition of ChemoCentryx, Tavneos's developer. Investors should monitor the outcome of the FDA's withdrawal proceedings and any further legal or regulatory actions.
At the time of this announcement, AMGN was trading at $327.64 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $176.8B. The 52-week trading range was $264.15 to $391.29. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.