Amgen Reports Strong Q4/FY25 Results, Advances MariTide, Faces FDA Challenge on TAVNEOS

summarizeSummary

Amgen reported robust Q4 and full-year 2025 financial results with double-digit revenue and EPS growth, provided positive 2026 guidance, and announced significant progress for its obesity drug MariTide, but also disclosed an FDA request to withdraw TAVNEOS from the market, which Amgen refused.

check_boxKey Events

• Strong Q4 & FY25 Financials

  Total revenues increased 9% in Q4 to $9.9 billion and 10% for the full year to $36.8 billion. GAAP EPS rose 111% in Q4 to $2.45 and 88% for the full year to $14.23.

• Positive 2026 Guidance

  The company projects total revenues between $37.0 billion and $38.4 billion, and non-GAAP EPS in the range of $21.60 to $23.00.

• MariTide Advances

  Positive long-term Phase 2 data for the obesity drug MariTide showed sustained weight loss and cardiometabolic improvements, with Phase 3 studies for Type 2 Diabetes expected in 2026.

• TAVNEOS Regulatory Challenge

  The FDA requested Amgen voluntarily withdraw TAVNEOS from the U.S. market due to concerns over clinical trial data, but Amgen refused, asserting confidence in the drug's benefit-risk profile.

auto_awesomeAnalysis

Amgen's latest earnings report showcases robust financial performance for the fourth quarter and full year 2025, exceeding expectations with double-digit revenue and GAAP EPS growth, and provides a positive outlook for 2026. A significant highlight is the promising long-term Phase 2 data for MariTide, its differentiated GLP-1/GIPR agonist for obesity, which demonstrated sustained weight loss and cardiometabolic improvements, positioning it as a potential blockbuster. The company also secured new approvals for UPLIZNA and full FDA approval for IMDELLTRA. However, the filing also reveals a critical regulatory challenge: the FDA requested Amgen to voluntarily withdraw TAVNEOS from the U.S. market due to concerns over clinical trial data re-adjudication and hepatotoxicity. Amgen's refusal to comply signals a potential dispute with the agency, introducing significant uncertainty and risk for the product and the company's regulatory standing. Additionally, Amgen confirmed the termination of the rocatinlimab collaboration with Kyowa Kirin, an event previously disclosed on January 30, 2026, and will not pursue regulatory approval for bemarituzumab in first-line gastric cancer, indicating pipeline rationalization. Investors will closely monitor the resolution of the TAVNEOS situation and the continued development of MariTide.