THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN), a prominent player in the biotechnology industry with a market capitalization of $167.88 billion, has announced results from the Phase 3 MINT trial of UPLIZNA® (inebilizumab-cdon) in adults with generalized myasthenia gravis (gMG), revealing sustained efficacy with twice-yearly dosing. The company, which has achieved impressive revenue growth of 18.57% over the last twelve months, continues to demonstrate strong innovation in its drug development pipeline. According to InvestingPro, Amgen maintains robust financial health with a 68.71% gross profit margin. The trial focused on patients with acetylcholine receptor autoantibody-positive (AChR+) gMG, showing continued improvement in daily activities compared to placebo over 52 weeks.
The MINT trial, a randomized-control study, followed AChR+ gMG patients for a year and muscle-specific kinase autoantibody-positive (MuSK+) gMG patients for 26 weeks. Results indicated a significant improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score among AChR+ patients receiving UPLIZNA, with 72.3% experiencing a ≥3 point improvement versus 45.2% in the placebo group.
Additionally, the Quantitative Myasthenia Gravis (QMG) score improvement was greater in the UPLIZNA group at Week 52. The study incorporated a corticosteroid taper, with patients on corticosteroids reducing to prednisone 5 mg per day by Week 24. No new safety signals were identified, and the most common adverse events were consistent with the known safety profile for UPLIZNA’s approved indication.
UPLIZNA is already approved for treating adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) and is under priority FDA review for Immunoglobulin G4-related disease (IgG4-RD). It has also received Orphan Drug Designation for the treatment of gMG, with regulatory filing activities expected to complete in the first half of 2025. Trading at $312.50, InvestingPro analysis suggests Amgen is currently fairly valued, with additional ProTips available for subscribers regarding the company’s dividend history and earnings outlook.
The findings are set to be presented at the American Academy of Neurology (AAN) Annual Meeting on April 8, 2025, in San Diego. Dr. Jay Bradner, executive vice president of Research and Development at Amgen, expressed that the results support the potential of UPLIZNA to set a new standard of care in gMG. Dr. Richard J. Nowak, global principal study investigator, also highlighted the consistent relief of symptoms and improved quality of life for patients. For detailed analysis of Amgen’s financial health and growth prospects, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers over 1,400 top US stocks with expert insights and actionable intelligence.
This news is based on a press release statement from Amgen.
In other recent news, Amgen reported robust fourth-quarter 2024 results, surpassing market expectations with strong revenue performance driven by key products such as Repatha, Evenity, and Tezspire. This positive outcome has led Bernstein analysts to adjust their price target for Amgen shares to $350, despite ongoing uncertainties surrounding the MariTide product. In contrast, Piper Sandler has raised its price target to $329, maintaining an Overweight rating, following enhanced insights into Amgen’s strategy for expanding Tezspire’s applications beyond severe asthma. Meanwhile, TD Cowen has reiterated its Buy rating with a $389 price target, citing positive clinical trial results for Amgen’s atopic dermatitis treatment, ROCA, which demonstrated improved safety and efficacy.
Additionally, Amgen has declared a quarterly dividend of $2.38 per share for the second quarter of 2025, reflecting its ongoing commitment to shareholder returns. The company has also launched a new technology and innovation site in Hyderabad, India, named Amgen India, with a $200 million investment plan through 2025. This site aims to enhance Amgen’s digital capabilities and advance its medicine pipeline, offering opportunities for local talent.
Amgen’s diverse growth opportunities continue to attract analyst attention, with Bernstein expressing optimism about the potential of the rare disease portfolio and the obesity pipeline. Despite challenges such as the anticipated loss of exclusivity for Prolia/Xgeva, analysts remain positive about Amgen’s long-term prospects. These recent developments underscore Amgen’s strategic initiatives and commitment to innovation in the biotechnology sector.
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