Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE: JNJ) announced FDA approval of TREMFYA® (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). TREMFYA® is the first dual-acting interleukin-23 inhibitor approved for UC, showing significant endoscopic remission rates at one year in the QUASAR program. Key findings include:

- 50% of patients on TREMFYA® 200 mg q4w and 45% on 100 mg q8w achieved clinical remission at week 44 vs 19% on placebo.
- 34% (200 mg) and 35% (100 mg) achieved endoscopic remission at one year vs 15% on placebo.

This approval marks TREMFYA®'s third indication, following plaque psoriasis and active psoriatic arthritis. The recommended dosage for UC is 200 mg induction dose at weeks 0, 4, and 8, followed by maintenance doses.

Johnson & Johnson (NYSE:JNJ) announced results from the Phase 2 SKIPPirr study, evaluating strategies to reduce infusion-related reactions (IRRs) with RYBREVANT® in non-small cell lung cancer patients. The study of 40 patients showed that prophylaxis with 8-mg dexamethasone for two days prior to the first infusion resulted in an all-grades IRR rate of 22.5 percent, a significant reduction from the 67.4 percent historically observed.

Key findings:

• All IRRs were Grade 1 or 2, with no hospitalizations required
• No Grade 3 or higher IRR events reported
• Most common IRR-related symptoms: nausea (8%), dyspnea (5%), and hypotension (5%)
• Safety profile consistent with previous studies

The study suggests that incorporating oral dexamethasone into the treatment regimen can help mitigate IRR risks, potentially improving the patient experience with RYBREVANT® treatment.

Johnson & Johnson (NYSE: JNJ) announced promising long-term data from the Phase 3 MARIPOSA study at the 2024 World Conference on Lung Cancer. The study evaluated RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) against osimertinib monotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC).

Key findings at three years follow-up:

• 61% survival rate for RYBREVANT® plus LAZCLUZE™ vs 53% for osimertinib
• Improved central nervous system disease control
• 40% of patients on RYBREVANT® combination still on treatment vs 29% on osimertinib
• Safety profile consistent with individual treatments

The FDA approved this combination therapy for first-line treatment of EGFR-mutated NSCLC in August 2024.

Johnson & Johnson (NYSE: JNJ) has announced an investor conference call to review its third-quarter results on Tuesday, October 15th at 8:30 a.m. Eastern Time. The call will be hosted by Joaquin Duato (Chairman and CEO), Joseph J. Wolk (EVP and CFO), and Jessica Moore (VP of Investor Relations). Additional executive team members will participate in the Q&A session.

Investors can access the webcast and presentation materials at www.investor.jnj.com. The U.S. dial-in number is 877-869-3847, while international participants can call 201-689-8261. A replay will be available until October 29th. The press release will be available at approximately 6:45 a.m. ET on the day of the call.

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