Amgen Stock Edges Higher After Uplizna Becomes First FDA-Approved Treatment For Immune-Mediated Disorder – Retail Gets More Bullish

Shares of medicine manufacturer Amgen Inc (AMGN) are in the spotlight on Friday after it announced that the U.S. Food and Drug Administration (FDA) has approved its drug Uplizna to reduce the risk of flares in adults living with a certain immune-mediated inflammatory condition.

The FDA granted Uplizna a Breakthrough Therapy Designation for treating Immunoglobulin G4-related disease (IgG4-RD), a chronic condition that can affect multiple organs and pose the risk of fibrosis and permanent organ damage.

Uplizna is now the first FDA-approved treatment for IgG4-RD, affecting an estimated 20,000 people in the U.S.

Jay Bradner, executive vice president of Research and Development at Amgen, said that the drug targets a key driver of the disease and reduces reliance on long-term steroid use.

"We are proud to deliver a therapy that has the potential to significantly improve care for patients with IgG4-RD and remain encouraged by Uplizna's broader potential in other immune-mediated diseases, including neuromyelitis optica spectrum disorder and generalized myasthenia gravis,” he added.

The approval was based on data from a placebo-controlled trial that showed the drug reduced the risk of IgG4-RD flare by 87% compared to a placebo.

The drug is administered by infusion. After two initial infusions, patients need one dose of Uplizna every six months.

The FDA previously approved it for the treatment of adult patients with an autoimmune disease called Neuromyelitis Optica Spectrum Disorder (NMOSD).

On Stocktwits, retail sentiment around Amgen jumped within ‘bullish’ territory (63/100) while message volume remained ‘high’ over the past 24 hours.

Investors on the platform are also relieved that pharmaceutical products were excluded from the sweeping tariffs President Donald Trump announced on Wednesday.

Amgen shares are up by over 18% this year and by over 14% over the past 12 months.

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