FDA Approves Amgen's UPLIZNA® (inebilizumab-cdon) for Generalized Myasthenia Gravis (gMG), Expanding Treatment Options for Patients Living with Autoimmune Neuromuscular Disease [Yahoo! Fin...
Amgen Inc. (AMGN)
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Source: Yahoo! Finance
Food and Drug Administration (FDA) approval of Amgen's UPLIZNA ® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. This is the first and only CD19-Targeted B-Cell therapy approved for gMG. The approval offers patients a new treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses. Read the Amgen press release here Uplizna is already FDA-approved for neuromyelitis optica spectrum disorder (NMOSD) and IgG4-related disease (IgG4-RD) — two immune-mediated disorders in which B cell depletion has shown meaningful clinical benefit. Myasthenia gravis (MG) shares similar B cell-driven autoimmune mechanisms, making Uplizna a strong therapeutic candidate for patients whose symptoms are caused by pathogenic autoantibodies. Myasthenia gravis (MG) shares similar B cell-driven auto
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News
- Amgen (NASDAQ:AMGN) was given a new $304.00 price target on by analysts at Morgan Stanley.MarketBeat
- FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS [Yahoo! Finance]Yahoo! Finance
- FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVISPR Newswire
- Amgen (NASDAQ:AMGN) had its price target raised by analysts at Wells Fargo & Company from $300.00 to $325.00. They now have an "equal weight" rating on the stock.MarketBeat
- Amgen (NASDAQ:AMGN) had its "buy" rating reaffirmed by analysts at HSBC Holdings plc.MarketBeat
AMGN
Earnings
- 11/4/25 - Beat
AMGN
Sec Filings
- 11/21/25 - Form 4
- 11/20/25 - Form 144
- 11/13/25 - Form 4
- AMGN's page on the SEC website