Amgen stock reversed higher Wednesday 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."
"Despite the current clinical hold, management still expects to develop AMG 513 and believes that the issue is not drug-related," Mizuho Securities analyst Salim Syed said in a report.
Amgen stock jumped 6.5% to 307.81 on today's stock market.
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, Syed said.
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.
Edward Jones analyst John Boylan pointed out Amgen is spending a lot of money to develop MariTide.
That "may explain 2025 EPS guidance being modestly lower than the current consensus view," he said in a note to clients. "In the meantime, MariTide speculation is overshadowing its progress on new products and its pipeline, although there are some upcoming patent expirations as well."
Boylan rates Amgen stock a hold.
Beyond MariTide, investors are also closely watching olpasiran. Amgen is developing it for patients with elevated lipoprotein A, or Lp(a). Like cholesterol, elevated Lp(a) can lead to an increased risk of heart attack, strokes and other cardiovascular problems. Amgen expects to begin an additional Phase 3 study of olpasiran in the second half of 2025 or first half of 2026.
Fourth-Quarter Metrics Topped
The fourth quarter 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% higher 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.
