FDA Proposes Withdrawing Amgen's Tavneos From U.S. Market
AMGN sits 38% above its 52-week low of $269.77.
Summary
The FDA has formally proposed withdrawing Amgen's rare-disease drug Tavneos from the U.S. market, escalating a safety saga that began with Japanese warnings in May and a NEJM trial retraction in early July. Amgen strongly disagrees and has submitted data seeking a hearing — a direct challenge that sets up a high-stakes regulatory fight. Tavneos generated $200M+ in annual sales; losing U.S. approval would erase a meaningful revenue stream and dent the pipeline's credibility. This follows the CFO's planned retirement and a $10.7B IRS dispute, adding to a growing list of headwinds. The hearing outcome will be the next major catalyst — no date yet set.
At the time of this announcement, AMGN was trading at $373.15 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $200.5B. 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 9 out of 10. Source: Reuters.