Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE:JNJ) announced positive topline results from the Phase 3 MARIPOSA study for RYBREVANT® plus LAZCLUZE™ as first-line therapy for EGFR-mutated non-small cell lung cancer. The combination demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) versus osimertinib, with median OS improvement expected to exceed one year.

The study, which enrolled 1,074 patients, evaluated the chemotherapy-free combination against the current standard of care. The trial met its final pre-specified secondary endpoint of OS, building upon previously reported positive progression-free survival data. The safety profile was generally consistent with individual treatments, though venous thromboembolic events were observed, which could be managed with prophylactic anticoagulants.

The treatment is already approved in the US and Europe for first-line treatment of EGFR-mutated NSCLC based on the MARIPOSA study. With less than 20% of patients living beyond five years, this improvement in survival represents a significant advancement in treatment options.

Johnson & Johnson (NYSE: JNJ) has announced its quarterly dividend for the first quarter of 2025. The Board of Directors has declared a cash dividend of $1.24 per share on the company's common stock. The dividend will be payable on March 4, 2025, to shareholders of record at the close of business on February 18, 2025. The ex-dividend date is set for February 18, 2025.

Johnson & Johnson (NYSE: JNJ) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The event will take place at the Westin St. Francis in San Francisco, CA, where Joaquin Duato, Chairman and Chief Executive Officer, will represent the company in a session scheduled for 12:00 p.m. (Eastern Time) on Monday, January 13th.

A live audio webcast will be accessible to investors and interested parties through the company's investor website at www.investor.jnj.com. The audio webcast replay will become available approximately 48 hours after the initial broadcast.

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.