UK Suspends Amgen's Tavneos for New Patients, Plans Full Revocation
AMGN sits 60% above its 52-week low of $269.77.
Summary
The UK medicines regulator suspended Tavneos for new patients, citing unreliable pivotal trial data, and plans to revoke approval on March 1, 2027. This follows the European Commission's revocation in August and the FDA's proposed US withdrawal. Amgen is challenging the US action and has submitted over 70 studies involving 2,200+ patients, but an independent review failed to confirm superiority over steroids at 52 weeks. The FDA has also linked Tavneos to 76 serious liver injury cases, including eight deaths. Tavneos was acquired via the $3.7B ChemoCentryx deal in 2022; the drug's global commercial future is now severely impaired. Watch for Amgen's response to the UK decision and any impact on the ongoing US withdrawal proceedings.
At the time of this announcement, AMGN was trading at $430.39 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $232.4B. 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.