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SPRING HOUSE, Pa. - Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years and older who are positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies. This approval is based on data from the pivotal Vivacity-MG3 study and its ongoing open-label extension, which demonstrated that IMAAVY, an FcRn-blocking monoclonal antibody, provided long-lasting disease control and symptom relief for gMG patients. With a robust gross profit margin of 68.9%, Johnson & Johnson has demonstrated its ability to effectively commercialize breakthrough treatments while maintaining profitability.
gMG is a chronic autoimmune disorder characterized by muscle weakness, which can lead to difficulties in speech and swallowing, among other daily challenges. The condition affects an estimated 700,000 people globally, with significant unmet needs for effective and sustained treatments.
The FDA’s approval follows a Priority Review designation and is supported by clinical trial data showing that patients treated with IMAAVY experienced substantial and rapid reductions in immunoglobulin G (IgG) levels, which are considered one of the root causes of gMG. The treatment has demonstrated a consistent safety profile across both adult and pediatric studies.
In the Vivacity-MG3 study, participants receiving IMAAVY plus standard of care showed superior disease control over a 24-week period compared to placebo, with maintained improvements lasting up to 20 months. Similarly, results from the ongoing Vibrance Phase 2/3 pediatric study indicated a 69% reduction in total serum IgG over 24 weeks, meeting its primary endpoint.
Johnson & Johnson has emphasized its commitment to patient access by offering a support program, IMAAVY withMe, which may allow commercially insured patients in the United States to start treatment quickly and potentially at no cost per infusion.
The company is also seeking approval for nipocalimab in the treatment of gMG with regulatory authorities worldwide. This news is based on a press release statement. For investors interested in Johnson & Johnson’s growth potential, InvestingPro analysis indicates the stock is currently undervalued, with additional ProTips highlighting the company’s 54-year history of dividend increases and stable price volatility. Access the comprehensive Pro Research Report for deeper insights into JNJ’s investment potential.
In other recent news, Johnson & Johnson reported its Q1 2025 earnings, surpassing Wall Street expectations with an adjusted EPS of $2.77, beating the forecast of $2.58, and revenue of $21.9 billion, exceeding the anticipated $21.57 billion. The company completed its acquisition of Intra-Cellular Therapies for $14.6 billion, further strengthening its neuroscience franchise. S&P Global Ratings maintained Johnson & Johnson’s ’AAA’ credit rating with a stable outlook following this acquisition, highlighting the company’s conservative financial policies and strong cash flows. Analysts from TD Cowen and UBS have maintained a Buy rating on Johnson & Johnson’s stock, with price targets of $185 and $180, respectively, reflecting confidence in the company’s growth strategies. Johnson & Johnson also presented promising clinical data for its bladder cancer treatment, TAR-200, at the American Urological Association 2025 Annual Meeting, indicating potential benefits for patients unresponsive to standard therapies. Additionally, the company announced plans to invest significantly in U.S. operations and new manufacturing facilities, which aligns with its strategy to bolster future performance. Despite facing headwinds such as competition from biosimilars and potential tariff impacts, analysts remain optimistic about Johnson & Johnson’s strategic planning and ability to sustain growth.
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