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SPRING HOUSE, Pa. - Johnson & Johnson (NYSE: JNJ) shared new data on nipocalimab’s efficacy in treating generalized myasthenia gravis (gMG), an autoimmune disorder. The findings were part of 12 abstracts presented at the American Academy of Neurology (AAN) Annual Meeting held from April 5 to 9 in San Diego, California.
The data includes results from the 24-week Phase 3 Vivacity-MG3 study, which demonstrated significant improvement in muscle strength in gMG patients using the clinician-administered QMG assessment score. The ongoing open-label extension (OLE) study further showed sustained disease control with nipocalimab across a broad population of antibody-positive adult patients. With an impressive gross profit margin of 69.56% and EBITDA of $29.94 billion, Johnson & Johnson demonstrates the financial strength to support its robust drug development pipeline. For deeper insights into J&J’s financial metrics and growth potential, investors can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed research reports.
In addition to the clinical study outcomes, real-world evidence underscored the unmet needs in gMG treatment, particularly among pregnant patients and those on oral corticosteroids. Studies pointed to the necessity for additional targeted treatments with safer profiles to minimize risks associated with current therapies.
Johnson & Johnson’s Vice President, Katie Abouzahr, M.D., expressed the company’s dedication to addressing critical unmet needs and improving patient outcomes through their research and development efforts.
The U.S. Food and Drug Administration (FDA) previously granted nipocalimab Priority Review based on the Biologics License Application filed in August 2024. The medication is designed to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, including autoantibodies and alloantibodies that contribute to various autoimmune conditions.
The company also highlighted the burden of gMG on patients, with around 700,000 people affected worldwide and approximately 100,000 individuals living with the condition in the U.S. alone. The presentations at AAN aimed to foster scientific exchange and drive progress in patient care for those living with gMG.
This article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has announced a significant $55 billion investment in the United States over the next four years, aiming to expand its manufacturing and research capabilities. This investment will include the construction of three new manufacturing facilities, including one in Wilson, North Carolina, and the expansion of existing sites. The company has also reported promising results from its Phase 3 MARIPOSA study for advanced non-small cell lung cancer, showing improved survival outcomes with its RYBREVANT® and LAZCLUZE™ combination therapy. Additionally, the FDA has granted Fast Track designation for Johnson & Johnson’s investigational drug nipocalimab for Sjögren’s disease, highlighting its potential to address unmet medical needs.
RBC Capital Markets has maintained its Outperform rating on Johnson & Johnson, citing the potential of Icotrokinra to generate over $5 billion in annual sales and contribute to the company’s long-term growth. However, Johnson & Johnson has decided not to pursue a licensing deal with Genmab for HexaBody-CD38, despite initial promising data. This decision follows Genmab’s evaluation of the drug’s clinical data and market potential. Despite this, Genmab remains focused on its other assets in late-stage development. These developments underscore Johnson & Johnson’s ongoing efforts to innovate and expand its pharmaceutical and research divisions.
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