Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE: JNJ) announced positive results from the Phase 2 DAHLIAS study of nipocalimab in treating moderate-to-severe Sjögren's disease. The investigational FcRn blocker demonstrated significant clinical improvements, with patients showing over 77% reduction in IgG levels and meeting primary endpoints in ClinESSDAI scores at 24 weeks. Key secondary endpoints were also met, showing reduced disease activity across multiple organ systems. The treatment showed particular effectiveness in patients with high baseline anti-Ro and anti-La autoantibodies. Notably, more than twice as many patients in the high-dose group (15 mg/kg) showed improved salivary flow compared to placebo (32.7% vs. 16%) at Week 24.

Johnson & Johnson announced that the FDA has granted Breakthrough Therapy Designation (BTD) for nipocalimab to treat adults with moderate-to-severe Sjögren's disease. This marks nipocalimab's second BTD, following its February designation for hemolytic disease of the fetus and newborn. The designation is supported by Phase 2 DAHLIAS study results, which showed over 70% relative improvement in systemic disease activity at Week 24 in participants receiving nipocalimab 15 mg/kg compared to placebo. Notably, nipocalimab is the first and only investigational therapy to receive this designation for Sjögren's disease, a condition currently lacking approved advanced treatments.

Johnson & Johnson (NYSE:JNJ) has submitted regulatory applications to the FDA and EMA seeking approval for DARZALEX FASPRO® as the first treatment for high-risk smoldering multiple myeloma. The applications are supported by the Phase 3 AQUILA study data. Smoldering multiple myeloma, an early precursor to active multiple myeloma, affects 15% of newly diagnosed multiple myeloma cases, with half of high-risk patients progressing to active disease within two years. Currently, the standard approach is observation until active disease develops. The first data from the AQUILA study will be presented at the 2024 ASH Annual Meeting in December.

Johnson & Johnson (NYSE: JNJ) will present 43 abstracts at the American College of Rheumatology (ACR) 2024 Annual Meeting, featuring new data across their rheumatology portfolio. Key highlights include results from the Phase 2 DAHLIAS study of nipocalimab in Sjögren's Disease, showing >70% relative average improvement compared to placebo, and findings from the PsABIOnd study demonstrating TREMFYA® (guselkumab) effectiveness in psoriatic arthritis. The presentations include three oral sessions and a plenary session, showcasing the company's continued innovation in rheumatic disease treatments.

Johnson & Johnson (NYSE: JNJ) announced positive Phase 3 GRAVITI study results for TREMFYA® (guselkumab), showing significant effectiveness in treating Crohn's disease through subcutaneous administration. At Week 12, 56.1% of TREMFYA-treated patients achieved clinical remission versus 21.4% for placebo. By Week 48, clinical remission rates were 60.0% for the 100mg dose and 66.1% for the 200mg dose, compared to 17.1% for placebo. Endoscopic response rates at Week 48 reached 44.3% and 51.3% for the two TREMFYA doses respectively, versus 6.8% for placebo. The drug maintained its established safety profile and could become the first IL-23 inhibitor offering both subcutaneous and intravenous options for Crohn's disease treatment.

Johnson & Johnson (NYSE: JNJ) announced positive results from the Phase 3b SPECTREM study of TREMFYA® in treating low body surface area plaque psoriasis with special site involvement. The study showed that 74.2% of TREMFYA®-treated patients achieved clear or almost clear skin compared to 12.4% for placebo. Significant clearance was demonstrated across all special sites including scalp, face, intertriginous areas, and genitals. The company also launched the TREMFYA® Clearance Photo Library, featuring before and after treatment photographs from the Phase 3b VISIBLE study to enhance clinical decision-making for patients across all skin tones.

Johnson & Johnson (NYSE: JNJ) announced the presentation of 23 abstracts featuring new real-world and clinical trial data from its neuropsychiatry portfolio at Psych Congress. Key highlights include five-year safety data from 35,000 adults treated with SPRAVATO®, insights into anhedonia in major depressive disorder (MDD), and an analysis of over 30,000 adults with schizophrenia examining the link between symptom relapse and mortality risk. The presentations cover treatment-resistant depression, MDD, and schizophrenia, showcasing data on SPRAVATO®'s long-term safety and efficacy, as well as insights from the company's long-acting injectable portfolio.

A Bridgeport jury has awarded $15 million to Evan Plotkin and his wife Martha Barry-Plotkin in a verdict against Johnson & Johnson (NYSE:JNJ) and several subsidiaries for damage linked to asbestos in the company's talc-based Baby Powder. Mr. Plotkin, diagnosed with mesothelioma in 2021, was exposed to J&J's product through personal use beginning in the 1950s and his children's use through the 2000s.

The jury awarded $15 million in compensatory damages and affirmed that punitive damages were justified, potentially increasing the final verdict amount. J&J subsidiaries Kenvue, Holdco, Pecos River, LLT, and LTL were also defendants in the lawsuit. J&J withdrew its talc powder from North American sales in 2020.

Mr. Plotkin, an artist and father of three, is recognized for his transformative work in downtown Springfield, Mass., as founder of City Mosaic, a nonprofit dedicated to fostering the area's visual arts community.

Johnson & Johnson (NYSE: JNJ) announced positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChR positive adolescents (aged 12-17) with generalized myasthenia gravis (gMG). The study showed that nipocalimab plus standard of care achieved sustained disease control over 24 weeks, with a 70% reduction in IgG and improvements in MG-ADL and QMG scores. Notably, 4 out of 5 patients achieved minimum symptom expression.

Nipocalimab was well-tolerated with no serious adverse events or discontinuations. These results are consistent with findings from the pivotal study in adult gMG patients. Johnson & Johnson has submitted applications to the FDA and EMA for nipocalimab's approval in gMG treatment.