UK Regulator Suspends Amgen's Tavneos for New Patients Over Unreliable Data
AMGN sits 61% above its 52-week low of $269.77 on light trading volume (0.2× avg).
Summary
The UK's MHRA has suspended Tavneos for new patients, citing unreliable data from the main trial, and plans to revoke approval on March 1, 2027. This follows the FDA's proposed withdrawal and the European Commission's revocation in August. The FDA has linked Tavneos to 76 cases of serious liver injury, including 8 deaths. Amgen disputes the decision, citing real-world studies, but the drug's global regulatory standing is deteriorating. Tavneos was acquired via the $3.7B ChemoCentryx deal in 2022, and this adds to the existing overhang from the FDA proposal and the $10.7B IRS tax dispute.
At the time of this announcement, AMGN was trading at $433.69 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $234.5B. The 52-week trading range was $269.77 to $447.03. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Reuters.