Johnson & Johnson Stock Price, News & Analysis

Johnson & Johnson (NYSE: JNJ) has submitted a Biologics License Application to the FDA for nipocalimab, seeking its first global approval to treat generalized myasthenia gravis (gMG). The application is based on the Phase 3 Vivacity-MG3 study, which demonstrated superior outcomes for antibody-positive participants receiving nipocalimab plus standard of care compared to placebo. The study included anti-AChR+, anti-MuSK+, and anti-LRP4+ antibody positive adults, covering about 95% of the gMG patient population.

Nipocalimab is the first FcRn blocker to show sustained disease control over 24 weeks with consistent dosing every other week. Its high binding affinity and specificity to FcRn's IgG binding site potentially differentiate it in the FcRn blocker class. The drug's safety and tolerability were consistent with previous studies.

Johnson & Johnson (NYSE: JNJ) announced significant presentations at the 2024 World Conference on Lung Cancer (WCLC) and European Society for Medical Oncology (ESMO) 2024 Congress. The company will showcase 11 oral presentations and 27 studies featuring new data in lung, bladder, prostate, and colorectal cancers. Key highlights include:

1. Latest overall survival data from the Phase 3 MARIPOSA study for RYBREVANT® plus LAZCLUZE™ in EGFR-mutated advanced NSCLC.
2. Primary results from the Phase 2 SKIPPirr study on preventing infusion-related reactions with RYBREVANT®.
3. First results from the Phase 1b/2 OrigAMI-1 study evaluating RYBREVANT® plus chemotherapy in metastatic colorectal cancer.
4. Late-breaking interim analysis results from the Phase 2 SunRISe-4 study on TAR-200 in muscle-invasive bladder cancer.

Johnson & Johnson (NYSE: JNJ) announced leadership changes in its Human Resources department. Dr. Peter M. Fasolo, Executive Vice President and Chief Human Resources Officer, will retire at the end of 2023 after 16 years with the company. He will be succeeded by Kristen Mulholland, effective October 1, 2024.

Mulholland, a veteran J&J employee since 2005, will also join the Executive Committee. She has held various HR leadership positions across the company's sectors and most recently served as Head of Human Resources, Global Total Rewards & Enterprise HR Functions.

During his tenure, Fasolo strengthened J&J's global Diversity, Equity & Inclusion outcomes, expanded employee benefits, and transformed the HR function's talent and leadership strategy. The transition period will allow for a smooth handover of responsibilities.

Johnson & Johnson (NYSE: JNJ) has announced its plan to acquire V-Wave , a company developing innovative heart failure treatments, for an upfront payment of $600 million with potential additional payments up to $1.1 billion. V-Wave's key product is the Ventura® Interatrial Shunt (IAS), a minimally invasive device designed to treat heart failure with reduced ejection fraction (HFrEF). This acquisition aims to strengthen J&J MedTech's position in cardiovascular care and address a significant treatment gap for approximately 800,000 HFrEF patients in the U.S. annually. The device has received FDA Breakthrough Device Designation and CE mark. The transaction is expected to close before the end of 2024, subject to regulatory approvals.

Johnson & Johnson (NYSE: JNJ) announced FDA approval of RYBREVANT® plus LAZCLUZE™ as the first chemotherapy-free treatment for EGFR-mutated advanced lung cancer. This combination reduced the risk of disease progression or death by 30 percent compared to osimertinib, with a nine-month-longer median duration of response. The approval is based on the Phase 3 MARIPOSA study results.

Key points:

• First-line treatment for adult patients with locally advanced or metastatic NSCLC with specific EGFR mutations
• Median progression-free survival: 23.7 months vs 16.6 months for osimertinib
• Median duration of response: 25.8 months vs 16.7 months for osimertinib
• Safety profile consistent with individual treatments

A South Carolina jury has awarded $63.4 million to Michael Perry, who sued Johnson & Johnson (NYSE:JNJ) claiming its Baby Powder caused his mesothelioma. The verdict includes $32.6 million in compensatory damages and $30.7 million in punitive damages. The jury found both J&J and co-defendant American International Industries negligent and liable, determining their actions were "willful, wanton or reckless".

Evidence presented showed J&J knew its talc-based products contained asbestos since 1970 but kept them on the market until 2019. This verdict follows a $260 million asbestos-related verdict against J&J in Oregon earlier this year, marking the fourth jury verdict in favor of Dean Omar Branham Shirley's clients in 2024.

Attorneys representing ovarian cancer victims in lawsuits against Johnson & Johnson (NYSE:JNJ) are advocating for the Ending Corporate Bankruptcy Abuse Act (ECBA). This bipartisan legislation aims to prevent solvent companies from using the 'Texas Two-Step' bankruptcy process to avoid lawsuit liabilities. J&J has twice attempted to use this tactic to resolve talc-related ovarian cancer claims.

The ECBA would treat such bankruptcy filings as bad faith and prohibit stays of litigation against non-bankrupt affiliates. Co-lead counsels Michelle Parfitt and Leigh O'Dell emphasize the legislation's importance in protecting justice and fairness. They highlight the financial devastation faced by victims, with average medical costs exceeding $220,000, while J&J earned over $83 billion in 2023.

The legislation has support from both Democratic and Republican lawmakers, who criticize the abuse of the bankruptcy system by wealthy corporations at the expense of harmed individuals. There are currently over 57,000 pending cases in the J&J Talcum Powder Products Liability Litigation.

Johnson & Johnson (NYSE: JNJ) announced promising results from the Phase 2 UNITY study of nipocalimab for treating pregnant individuals at risk of early onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN). The study, published in The New England Journal of Medicine, met its primary endpoint with 54% of participants achieving live birth at or after 32 weeks without needing intrauterine transfusion (IUT).

Key findings include:

• Nipocalimab delayed or prevented severe fetal anemia
• Reduced need for IUTs in high-risk pregnancies
• 92% live births in study pregnancies vs. 38% in qualifying pregnancies
• No incidences of fetal hydrops in study pregnancies

The AZALEA Phase 3 study is currently enrolling patients to further assess nipocalimab's efficacy and safety in severe HDFN treatment.

Johnson & Johnson (NYSE:JNJ) announced FDA approval for DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The approval is based on the Phase 3 PERSEUS study, which showed:

1. 60% reduction in risk of disease progression or death with D-VRd compared to VRd
2. Improved minimal residual disease negativity rates: 57.5% vs 32.5%
3. Deeper responses at the end of consolidation

This quadruplet therapy offers a new frontline treatment option that may significantly improve outcomes for patients. The safety profile was consistent with known profiles for DARZALEX FASPRO® and VRd.