What Amgen Found
Amgen said Tuesday that its investigational therapy dazodalibep cleared the primary endpoint in a late-stage study of patients with moderate to severe Sjögren's disease. The company reported a statistically significant effect that it also described as clinically meaningful after 48 weeks of treatment, and noted that some participants began to improve within four weeks.
Common side effects reported were swelling inside the nose, urinary tract infections, increased blood pressure, and infusion-related reactions. Jay Bradner, Amgen's EVP responsible for R&D, AI, and data, said the readout "reinforces our confidence in dazodalibep," adding that it supports the broader program for people living with this autoimmune condition.
What Comes Next and Who's Watching
Analysts say the second pivotal study is vital to gauge the size of the effect, with completion targeted before year end. Should the program hit its goals, Citi analyst Geoff Meacham estimates the drug could ultimately bring in $1.1 billion in annual revenue.
Why It Matters for Patients and Markets
Sjögren's is an autoimmune disorder where the body's defenses attack its own tissues, often the glands that produce tears and saliva, leading to dry eyes, dry mouth, and complications like fatigue and chronic pain. Around 4 million people in the US are affected. Care today centers on easing symptoms with treatments such as eye drops and anti inflammatory medicines because there are no FDA approved therapies for the disease.
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Investors took notice: as of 10:08 a.m. Tuesday in New York, Amgen gained 1.7%, and the shares have risen 22% year to date.
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