Amgen Shares Rise on Positive Phase 3 Data for Sjögren’s Disease Drug

Shares of Amgen (AMGN) surged in morning trading after the biopharmaceutical company announced positive results from a late-stage clinical trial for its drug candidate, dazodalibep. The stock climbed 3.5% to a session high of $407, significantly outperforming the broader market.

Key Trial Results

Amgen reported that its Phase 3 OASIZ 301 study of dazodalibep for adults with moderate-to-severe systemic Sjögren’s disease met its primary endpoint. The company stated the drug delivered a statistically significant and clinically meaningful improvement in systemic disease activity at Week 48.

Key findings from the announcement include:

• Measurable benefits were observed as early as Week 4 and were sustained throughout the trial.
• Dazodalibep is a potential first-in-class CD40L antagonist designed to disrupt the immune response driving the disease.
• The results are particularly notable as there are currently no FDA-approved disease-modifying therapies for this high-unmet-need autoimmune indication.

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Market Impact and Outlook

The positive data prompted a strong investor response, with Amgen's stock gain far outpacing the S&P 500's modest 0.1% rise. The development provides a boost to Amgen's late-stage pipeline, a key focus for investors in the large-cap biotechnology sector.

Analyst commentary remained measured. According to the source, Citi reaffirmed a Hold rating with a $405 price target, while Barclays also maintained its Hold stance. Another unnamed analyst reportedly kept a Buy rating, citing the company's fundamentals and pipeline potential. Amgen also noted that a companion Phase 3 study is expected to complete in the fourth quarter of this year, providing another potential catalyst for the program.