Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the FDA for a subcutaneous induction regimen of TREMFYA® to treat adults with moderately to severely active ulcerative colitis (UC). The submission is backed by the Phase 3 ASTRO study, which met its primary endpoint of clinical remission at Week 12 and all secondary endpoints. The study demonstrated significant results with a 400 mg subcutaneous induction dose administered at Weeks 0, 4, and 8. If approved, TREMFYA® would be the first IL-23 inhibitor offering both subcutaneous and intravenous induction options for UC treatment.

Johnson & Johnson (NYSE:JNJ) will present over 90 abstracts at the 66th American Society of Hematology Annual Meeting, showcasing data from its blood cancer portfolio and pipeline. The presentations will feature clinical trial and real-world data highlighting the company's expanding portfolio of hematologic therapies, with focus on multiple myeloma, myeloid and B-cell malignancies. Key presentations include data from Phase 3 studies of DARZALEX FASPRO®, CARVYKTI®, and TECVAYLI®, along with research on IMBRUVICA® combinations and the menin inhibitor bleximenib for acute myeloid leukemia. Additional research addresses warm autoimmune hemolytic anemia and fetal/neonatal alloimmune thrombocytopenia.

Johnson & Johnson (NYSE: JNJ) announced positive Phase 3 topline results for icotrokinra (JNJ-2113), a first-in-class oral peptide targeting IL-23 receptor for moderate to severe plaque psoriasis. The drug met its co-primary endpoints, with 64.7% of patients achieving clear/almost clear skin (IGA 0/1) and 49.6% achieving PASI 90 at week 16, compared to 8.3% and 4.4% on placebo. Results improved at week 24, with 74.1% achieving IGA 0/1 and 64.9% reaching PASI 90. Safety profile aligned with Phase 2 studies, showing similar adverse events between treatment and placebo groups.

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.