Amgen’s Strategic Crossroads: Regulatory Wins Offset by Mounting Competition

Amgen Inc. finds itself navigating a complex landscape of significant opportunity and intensifying market pressures. The biotechnology giant has recently secured notable regulatory and financial victories, yet these are counterbalanced by emerging competitive threats to its core products. This mixed fundamental picture leaves investors questioning whether the stock’s performance over the past year can be reversed.

Billion-Dollar Oncology Deal Bolsters Cash Reserves

A landmark transaction in Amgen’s oncology portfolio has provided a substantial and immediate financial boost. Royalty Pharma has entered an agreement to acquire a license participation in the lung cancer treatment, Imdelltra (tarlatamab-dlle), for up to $950 million. A significant portion of this sum, $885 million, was paid upfront to Amgen. In exchange, Royalty Pharma will receive approximately seven percent of the drug’s global net sales. This deal, centered on a therapy that received accelerated FDA approval in May 2024, represents a powerful vote of confidence in its commercial potential.

FDA Broadens Access for Cholesterol Drug Repatha

In a separate development with significant long-term revenue implications, Amgen received expanded U.S. regulatory approval for its cholesterol-lowering drug, Repatha (evolocumab). The FDA has removed a previous restriction, now authorizing its use not only for patients with established cardiovascular disease but also for adults at an increased risk of major cardiovascular events due to uncontrolled LDL cholesterol. This decision substantially widens the drug’s addressable market, particularly catering to the patient population for whom statins are either ineffective or not well-tolerated.

Should investors sell immediately? Or is it worth buying Amgen?

Biosimilar Challenge Emerges for Hematology Drug Nplate

However, the company faces a growing challenge in its hematology segment. Recent study data confirms the efficacy of a biosimilar, known as GP40141, for Amgen’s bleeding disorder medication Nplate (romiplostim). Findings published in July and August demonstrated therapeutic equivalence in treating chronic immune thrombocytopenic purpura (ITP). This advancement signals the imminent arrival of increased pricing pressure in this therapeutic area, potentially eroding Nplate’s market share and long-term profitability.

Market Analysts Maintain Cautious Stance

Equity researchers are reflecting this dual narrative of promise and pressure in their assessments. While Piper Sandler recently reaffirmed its “Overweight” rating on Amgen shares and raised its price target from $328 to $342, the broader analyst consensus remains one of guarded optimism. From a technical perspective, the stock is currently exhibiting a neutral oscillatory pattern, lacking a definitive directional trend—a fitting technical reflection of the opposing fundamental forces at play.

The central question for investors remains: Will the financial firepower from recent deals and the expanded commercial opportunities be sufficient to overcome the stock’s downward trajectory of the last twelve months, or will mounting competitive headwinds stifle a meaningful recovery?