Amgen's Tavneos Trial Retracted Over FDA-Found Altered Data; Company Sues Colorado Over Enbrel Price Cap
AMGN sits 38% above its 52-week low of $269.77.
Summary
Amgen faces a dual blow with the retraction of its 2021 Tavneos trial from NEJM after the FDA found altered data and unblinding. This serious regulatory issue follows previous warnings and prescribing halts for Tavneos in Japan due to adverse events. Separately, Amgen is suing Colorado over a $600 weekly price cap on its blockbuster drug Enbrel, threatening to halt sales in the state. While a federal judge recently blocked Colorado's price cap attempt, the ongoing legal battle highlights significant revenue protection efforts. The Tavneos data integrity issues are a major concern for the drug's future and Amgen's regulatory credibility. An FDA hearing for Tavneos re-adjudication is scheduled for July 29.
At the time of this announcement, AMGN was trading at $373.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $201.9B. The 52-week trading range was $269.77 to $391.29. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Wiseek News.