Johnson & Johnson (JNJ) Stock News

Johnson & Johnson (NYSE:JNJ) has submitted a supplemental New Drug Application (sNDA) to the FDA for CAPLYTA® (lumateperone) based on impressive Phase 3 trial results in schizophrenia relapse prevention. The study demonstrated a 63% reduction in relapse risk compared to placebo, with significantly longer time to relapse during the 26-week double-blind treatment phase (p=0.0002).

The trial's safety profile remained consistent with existing clinical data, with headache being the most common adverse event. CAPLYTA® is already FDA-approved for schizophrenia treatment and is the first approved therapy for both bipolar I and II depression. The drug's mechanism involves high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy at therapeutic doses.

Johnson & Johnson (JNJ) announced new data showing IMAAVY (nipocalimab-aahu) demonstrated superior sustained disease control compared to other FcRn blockers in treating generalized myasthenia gravis (gMG). The indirect treatment comparison (ITC) revealed IMAAVY achieved comparable symptom relief at Week 1 and showed greater or statistically significant improvement in MG-ADL scores versus competitors over 24 weeks. IMAAVY, which received FDA approval for treating both adult and pediatric gMG patients aged 12 and older, features a predictable biweekly dosing regimen. The drug showed significantly greater mean improvements versus one comparator at Weeks 8-24 and another at Weeks 10-14, with population-adjusted ITCs showing favorable results for IMAAVY. This data strengthens IMAAVY's position as a treatment option for gMG patients, particularly given its broad approval for both anti-AChR and anti-MuSK antibody positive patients.

A Suffolk County jury has ordered Johnson & Johnson (NYSE:JNJ) to pay $8 million in damages to Janice Paluzzi, an 84-year-old Massachusetts woman who developed mesothelioma after long-term use of J&J's talcum powder products. The jury found J&J liable for negligence and breach of warranty, concluding that the company's asbestos-contaminated talc products caused Paluzzi's terminal cancer. Evidence presented during the trial revealed that J&J had internal knowledge of asbestos contamination in its talc supply for decades but continued marketing the products as safe. The company discontinued talc-based products in the US in 2020. Paluzzi, who used J&J's Baby Powder on herself and her seven children, was diagnosed with mesothelioma in 2021.

Johnson & Johnson announced promising results from Phase 2 RedirecTT-1 study evaluating the combination of TALVEY and TECVAYLI in multiple myeloma patients with extramedullary disease (EMD). The study showed a high overall response rate (ORR) of 78.9% in heavily pretreated patients, with 54.4% achieving complete response or better. The trial, involving 90 patients, demonstrated durable responses with 61% of patients progression-free at one year and 74.5% survival rate. The combination therapy showed efficacy even in patients previously treated with BCMA CAR-T therapy (83.3% ORR) or anti-FcRH5 bispecific antibodies (75% ORR). The safety profile aligned with previous monotherapy results, with manageable side effects and low discontinuation rates.

Johnson & Johnson announced promising first clinical data from a Phase 1b study of JNJ-90014496, a novel dual-targeting CD19/CD20 CAR T-cell therapy for relapsed/refractory large B-cell lymphoma. The therapy showed impressive efficacy with 80% complete response rate in patients with one prior treatment line and 75% in those with two or more prior treatments. At the recommended Phase 2 dose of 75 million CAR+ T-cells, the therapy demonstrated a favorable safety profile with no Grade 3/4 cytokine release syndrome observed. The study involved 22 patients for efficacy assessment, achieving 100% objective response rate in single prior therapy patients and 92% in multiple prior therapy patients. This development represents a potential advancement over current single-antigen CAR T therapies, which typically achieve only 40% long-term remission rates.

Johnson & Johnson announced promising Phase 1b data for bleximenib (JNJ-75276617), an investigational selective menin inhibitor, in combination with venetoclax and azacitidine for acute myeloid leukemia (AML). The study evaluated 125 patients with KMT2A gene rearrangements or NPM1 gene mutations. At the recommended Phase 2 dose of 100mg twice daily, relapsed/refractory AML patients showed an 82% overall response rate and 59% complete response rate, while newly diagnosed patients achieved 90% and 75% respectively. The safety profile was favorable, with only 4% of patients experiencing differentiation syndrome and no significant QTc prolongation. Common adverse events included nausea (65%), thrombocytopenia (61%), neutropenia (59%), and anemia (49%).

Johnson & Johnson announced significant findings from their Phase 3b APEX study for TREMFYA (guselkumab) in treating active psoriatic arthritis (PsA). The study demonstrated TREMFYA's superior efficacy in inhibiting joint structural damage compared to placebo, with mean vdH-S score changes of 0.55 (Q4W) and 0.54 (Q8W) versus 1.35 for placebo. The drug showed impressive results with over 40% of treated patients achieving ACR50 at Week 24, and approximately 67-68% achieving ACR20. Notably, 63-67% of TREMFYA-treated patients experienced no radiographic progression compared to 53% in the placebo group. The drug also demonstrated significant skin clearance benefits, with 68-73% of treated patients achieving clear or almost clear skin (IGA score 0/1) versus 31% for placebo. TREMFYA maintains its established safety profile with no new safety concerns identified.

Johnson & Johnson (NYSE: JNJ) has announced the election of Daniel Pinto, President of JPMorganChase, to its Board of Directors. Pinto brings extensive financial expertise and deep understanding of global capital markets to JNJ's board. CEO Joaquin Duato emphasized that Pinto's unique perspective and experience will be valuable as the company continues to invest in healthcare innovation. Pinto expressed admiration for JNJ's commitment to scientific innovation and improving health outcomes, stating his honor in joining the board to serve alongside members dedicated to improving global health and well-being.

Johnson & Johnson (JNJ) announced promising Phase 1 trial results for JNJ-79635322 (JNJ-5322), a novel trispecific antibody for treating relapsed or refractory multiple myeloma. The trial showed an impressive 86.1% overall response rate among 36 patients at the recommended Phase 2 dose, with 100% response in BCMA and GPRC5D therapy-naive patients. JNJ-5322 uniquely targets three distinct proteins: BCMA and GPRC5D on myeloma cells and CD3 on T-cells. The study involved 126 patients with 8.2 months median follow-up. While cytokine release syndrome occurred in 59% of patients, no cases were Grade 3 or higher. However, 28% experienced Grade 3+ infections, and four treatment-related deaths were reported, including one from adenoviral encephalitis.