Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE: JNJ) has announced its upcoming fourth-quarter results conference call, scheduled for Wednesday, January 22nd at 8:00 a.m. (Eastern Time). The call will be hosted by Chairman and CEO Joaquin Duato, CFO Joseph J. Wolk, and VP of Investor Relations Jessica Moore.

The presentation will be accessible via webcast at www.investor.jnj.com, with a replay available approximately three hours after the call. U.S. participants can dial 877-869-3847, while international participants should use 201-689-8261. The replay will be available until February 5th. The press release will be published at 6:45 a.m. ET on the day of the call.

Johnson & Johnson (NYSE:JNJ) announced new results from the Phase 3 CARTITUDE-4 study showing that CARVYKTI® significantly outperformed standard therapies in treating relapsed or refractory multiple myeloma. The study demonstrated that 89 percent of CARVYKTI-treated patients achieved minimal residual disease (MRD) negativity, compared to 38 percent with standard therapies.

At a median follow-up of 34 months, sustained MRD-negative complete response was five times higher in CARVYKTI patients (52 percent vs 10 percent). The study included 419 patients (208 CARVYKTI, 211 standard therapies) who had received one to three prior lines of therapy. Patient-reported outcomes showed 83 percent of CARVYKTI-treated patients had no worsening of functional impacts after three years, versus 69 percent in the standard therapies group.

Johnson & Johnson (NYSE: JNJ) presented research at ASH 2024 highlighting the significant burden of warm autoimmune hemolytic anemia (wAIHA), a rare condition affecting approximately 50,000 people in the U.S. The research emphasizes the lack of FDA-approved therapies and high unmet need for targeted treatments.

The findings reveal that wAIHA patients experience severe symptoms, including debilitating fatigue and shortness of breath, alongside high healthcare resource utilization. Patient council feedback indicated anxiety about the cyclical nature of the condition and dissatisfaction with current treatments. A sentiment analysis of 22,000 conversations showed negative experiences with rituximab, a common treatment approach.

The company is evaluating nipocalimab as a potential treatment in the Phase 2/3 ENERGY study, with results expected in 2025.

Johnson & Johnson announced positive data for DARZALEX FASPRO®-based regimens in treating newly diagnosed multiple myeloma. The Phase 3 CEPHEUS study showed significantly higher minimal residual disease (MRD) negativity rates with DARZALEX FASPRO® plus VRd versus VRd alone, with 85% of MRD-negative patients remaining progression-free at 4.5 years.

At 58.7 months follow-up, overall MRD-negativity rates were significantly higher with D-VRd versus VRd at both sensitivity thresholds (60.9% vs 39.4% at 10-5; 46.2% vs 27.3% at 10-6). The AURIGA study demonstrated higher MRD-negative conversion rates in specific patient subgroups, including older patients (52.6% vs 17.5%) and Black patients (60% vs 16.7%).

Johnson & Johnson (NYSE:JNJ) announced promising frontline data for TECVAYLI® in treating newly diagnosed multiple myeloma (NDMM) from two studies. The MajesTEC-5 study showed 100% MRD negativity in evaluable patients when TECVAYLI® was combined with existing therapies as induction treatment. The MajesTEC-4 study demonstrated TECVAYLI®'s potential as maintenance therapy post-transplant.

In MajesTEC-5, 49 transplant-eligible NDMM patients were treated, with manageable safety profiles. Key adverse events included Grade 1/2 CRS in 65% of patients, and Grade 3/4 events including lymphopenia (43%), neutropenia (57%), and infections (35%). No ICANS cases were reported.

MajesTEC-4 showed promising results with low rates of non-hematologic Grade 3/4 adverse events and treatment discontinuation at 5.3%. All evaluable patients achieved MRD negativity at their respective assessment points.

Johnson & Johnson (NYSE: JNJ) announced significant results from the Phase 3 AQUILA study of DARZALEX FASPRO® for high-risk smoldering multiple myeloma (SMM). The study showed a 51% reduction in progression risk to active multiple myeloma compared to standard monitoring.

Key findings at 65.2 months median follow-up include: 63.1% versus 40.8% patients remained progression-free at 60 months, 93% versus 86.9% five-year survival rates, and 63.4% versus 2.0% overall response rates for DARZALEX FASPRO® versus active monitoring respectively.

Grade 3/4 adverse events occurred in 40.4% of treated patients versus 30.1% in monitored patients. The company has submitted applications to FDA and EMA for treatment approval in high-risk SMM patients.

Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the FDA for TREMFYA® (guselkumab), seeking approval for treating children aged 6+ with moderate-to-severe plaque psoriasis and children aged 5+ with active juvenile psoriatic arthritis. The submissions are based on data from the Phase 3 PROTOSTAR study, along with pharmacokinetic data from adult studies VOYAGE 1 and 2 for psoriasis, and DISCOVER 1 and 2 for psoriatic arthritis. TREMFYA® is the first approved monoclonal antibody that selectively targets the p19 subunit of IL-23.

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.