Amgen stock skidded late Tuesday after the biotech behemoth said the Food and Drug Administration placed one of its obesity treatments on clinical hold.
This means Amgen can't run testing of the drug it calls AMG 513 in patients. The company didn't specify the reason for the clinical hold, only saying "discussions are underway on a path forward to reopen the study."
Amgen stock fell more than 1% in after-hours trading, hitting 283.79.
The disclosure isn't related to Amgen's leading weight-loss drug, MariTide. Amgen says it expects to have the results of a midstage study of MariTide in patients with type 2 diabetes in the latter half of the year. The study will focus on patients living with and without obesity.
Amgen Stock: Guidance Mixed
The most important numbers for Amgen are in its guidance, Mizuho Securities analyst Salim Syed said in a client note.
For the year, Amgen guided to adjusted earnings of $20 to $21.20 per share. The midpoint of the outlook, $20.60, lagged analysts' call for $20.92, according to FactSet. But the middle of Amgen's sales guidance for $34.3 billion to $35.7 billion came in ahead of the Street's call for $34.63 billion.
The fourth quarter, though, represented a beat for Amgen.
Across all products, sales increased 11% to $9.09 billion, beating expectations for $8.88 billion. The company also had 13% growth in adjusted earnings, bringing in $5.31 per share. Analysts called for a lower $5.08 per share.
Amgen's biggest moneymaker, osteoporosis drug Prolia, generated $1.17 billion in sales. Sales rose 5% year over year, but missed forecasts for $1.19 billion. Repatha, on the other hand, generated $606 million in sales, growing 45% and beating expectations for $558 million. Repatha is a cholesterol drug.
Mizuho's Syed kept his neutral rating on Amgen stock.
Shares have run more than 12% after hitting a recent bottom at 257.05 on Jan. 6. Amgen stock is involved in a lengthy consolidation with a buy point at 346.85, according to MarketSurge.
