AMGN Jumps After Win In Sjögren’s Disease Trial As Citi Flags ‘Open Questions’

• No U.S. Food and Drug Administration-approved medicine currently treats persistent systemic Sjögren’s disease. 
• Amgen’s second late-stage study in patients with Sjögren’s disease is expected to finish in the fourth quarter. 
• Citi argues that the magnitude of efficacy and competitive profile of dazodalibep “remain open questions” until more “fulsome data” are presented.

Shares of Amgen (AMGN) rallied as much as 5% on Tuesday after the company said its experimental autoimmune drug dazodalibep reduced disease intensity in patients with moderate-to-severe systemic Sjögren’s disease in a late-stage study.

At the time of writing, AMGN was trading 4% higher as investors reacted to Amgen’s first late-stage win for a potential systemic treatment in a disease that still has no approved disease-modifying therapy. However, Citi is awaiting more details on the study.

Positive Trial Results

The OASIZ 301 trial enrolled about 621 adults with meaningful whole-body disease activity. After 48 weeks, dazodalibep produced a statistically significant and clinically meaningful improvement on a standard score of how the disease affects organs and systems. The company said gains appeared as early as week 4 and lasted through the study.

Sjögren’s is a common autoimmune illness that attacks moisture-producing glands and can spread to joints, nerves and major organs. Patients often live with dry eyes and mouth, severe fatigue and chronic pain. No U.S. Food and Drug Administration-approved medicine currently treats persistent systemic disease.

Side effects were generally mild to moderate in the trial, Amgen said. The most common events seen more often with the drug than placebo included colds, urinary tract infections, higher blood pressure and infusion reactions. Few patients stopped treatment, and rates were similar across groups. No imbalance in blood clots or opportunistic infections was observed.

Amgen gained dazodalibep through its 2023 purchase of Horizon Therapeutics. A second late-stage study in patients with heavy symptoms but lower systemic activity is expected to finish in the fourth quarter.

Citi Still Wants The Full Picture

Citi said Amgen’s dazodalibep delivered “positive” late-stage results in systemic Sjögren’s, which reduces clinical risk for “a potentially underappreciated I&I (Immunology and Inflammation) asset.” However, several details that matter are absent from the topline release, so the firm argues that the magnitude of efficacy and competitive profile “remain open questions” until more “fulsome data” are presented. Citi has a Neutral rating and a $405 price target on Amgen shares, implying a potential upside of 3% from the stock’s Monday close.

Other firms developing Sjögren’s treatments include Novartis and Johnson & Johnson.

How Did AMGN Retail Traders React?

On Stocktwits, retail sentiment around AMGN stock stayed in ‘bearish’ territory over the past 24 hours, while message volume remained ‘low.’

AMGN stock has gained 25% year-to-date. 

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