Amgen Stock Drops 3.09% Despite FDA Approval for Uplizna

On April 9, 2025, Amgen's stock experienced a 3.09% drop in pre-market trading, marking a significant decline that has drawn considerable attention from investors and analysts alike.

Amgen recently announced that its drug Uplizna (Inebilizumab/伊奈利珠单抗) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with IgG4-related disease (IgG4-RD). This approval is based on a global, multi-center study conducted in 22 countries, which demonstrated that Uplizna significantly reduced the risk of disease flare-ups and decreased patients' dependence on corticosteroids compared to a placebo.

This approval expands the therapeutic indications for Uplizna, which was previously approved in 2020 for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The new indication not only broadens the drug's applicability but also underscores Amgen's commitment to developing innovative therapies.

Despite the positive regulatory news, investors remain cautious about the stock's recent performance. The company's focus on expanding its oncology portfolio and gaining approvals for rare disease treatments is expected to drive future growth. However, short-term market volatility is a common occurrence, and investors are advised to monitor the drug's market performance and further research developments closely.

In this context, investors should maintain a balanced perspective, observing the market's acceptance of Amgen's new drug and its sales performance. For those with a higher risk tolerance, the current market conditions might present an opportunity to buy at a lower price. However, any investment decision should be based on a comprehensive analysis of the company's fundamentals and market conditions, avoiding impulsive actions.