FDA Links Amgen's Tavneos to Dozens of Liver Injuries, 8 Deaths
AMGN sits 33% above its 52-week low of $261.43 on light trading volume (0.2× avg).
Summary
The FDA has publicly stated that Amgen's drug Tavneos, used to treat blood vessel inflammation, has been linked to 76 cases of serious drug-induced liver injuries, including 8 deaths and 54 hospitalizations. The agency explicitly called these "new safety concerns" for the drug, which was the primary asset from Amgen's $3.7 billion acquisition of ChemoCentryx in 2022. This development escalates prior regulatory concerns, as the FDA had previously requested Amgen to withdraw Tavneos from the U.S. market in January due to hepatotoxicity risks, a request the company refused. This explicit link to patient deaths and serious adverse events by a top-tier regulator is a material negative event, likely to impact Tavneos's sales, market access, and Amgen's reputation, potentially leading to further restrictive regulatory actions.
At the time of this announcement, AMGN was trading at $348.74 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $188B. The 52-week trading range was $261.43 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.