SPRING HOUSE, Pa. - Johnson & Johnson (NYSE: JNJ (NYSE:JNJ)) disclosed today that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation (BTD) to nipocalimab for the treatment of moderate-to-severe Sjögren's disease (SjD). This marks the second BTD for nipocalimab, with the first granted earlier this year for hemolytic disease of the fetus and newborn. The designation was granted based on Phase 2 DAHLIAS study results, which showed a greater than 70 percent relative improvement in systemic disease activity at Week 24 for patients receiving nipocalimab compared to those on placebo.
SjD is a prevalent autoantibody disease that significantly affects quality of life, with symptoms that can interfere with daily activities. The disease is more common in women and can lead to complications such as B-cell lymphomas and increased mortality risk. Currently, there are no approved advanced therapies that address the underlying causes of SjD.
The BTD for nipocalimab is significant as it is the only investigational therapy to receive this status for SjD. The FDA's BTD program aims to expedite the development and review of drugs intended to treat serious or life-threatening conditions, which show potential for substantial improvement over existing therapies based on preliminary clinical evidence.
Johnson & Johnson's Vice President, Terence Rooney, emphasized the importance of this milestone, highlighting the need for innovative treatments that directly address the underlying causes of autoantibody-driven diseases like SjD. The company is committed to developing novel therapies that could improve patient outcomes.
The Phase 3 study of nipocalimab is currently underway, further evaluating the investigational treatment's efficacy and safety. Nipocalimab has also received several key designations from the FDA and EMA for other conditions, indicating its potential across various autoantibody-mediated diseases.
This news is based on a press release statement and does not constitute an endorsement of the drug's efficacy or safety. Further clinical trials and regulatory reviews will determine the future availability of nipocalimab for SjD patients.
In other recent news, Johnson & Johnson has submitted applications to the FDA and EMA for a new indication of DARZALEX FASPRO® in the treatment of high-risk smoldering multiple myeloma. The company has also reported robust Q3 results with operational sales growth of 6.3%, reaching $22.5 billion. In response to these strong results, RBC Capital Markets and Stifel Financial (NYSE:SF) have raised their price targets for Johnson & Johnson to $181.00 and $170.00, respectively.
Johnson & Johnson is also making strides in its Phase 3 GRAVITI study of TREMFYA® for treating Crohn's disease, with promising results indicating the drug could become the first IL-23 treatment for the condition. However, the company faces legal challenges, including a recent order to pay $15 million in a talc cancer case. These developments are part of recent news surrounding Johnson & Johnson, highlighting the company's diverse operational activities and potential growth areas.
InvestingPro Insights
Johnson & Johnson's recent breakthrough in Sjögren's disease treatment aligns well with its strong position in the pharmaceutical industry. According to InvestingPro data, J&J boasts a substantial market capitalization of $373.88 billion, underscoring its significance in the healthcare sector.
An InvestingPro Tip highlights that J&J is a "prominent player in the Pharmaceuticals industry," which is evident from its continued innovation in treatments like nipocalimab. This leadership position is further supported by the company's robust financials, with a reported revenue of $87.7 billion in the last twelve months as of Q3 2023.
Another relevant InvestingPro Tip notes that J&J "has raised its dividend for 54 consecutive years." This long-standing commitment to shareholder returns, coupled with a current dividend yield of 3.19%, may appeal to investors looking for stability alongside growth potential from breakthroughs like the recent FDA designation.
It's worth noting that J&J's P/E ratio (adjusted) stands at 17.17, which could indicate a reasonable valuation considering the company's innovative pipeline and consistent dividend growth. For investors seeking more comprehensive analysis, InvestingPro offers additional tips and metrics to further evaluate J&J's investment potential.
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