Johnson & Johnson Stock Price, News & Analysis

Johnson & Johnson (NYSE: JNJ) announced interim data from the Phase 2 SunRISe-4 study, showing that neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) nearly doubled the pathological complete response (pCR) rate compared to CET alone in patients with muscle-invasive bladder cancer (MIBC). Key findings include:

- 42% pCR rate for TAR-200 plus CET vs. 23% for CET alone
- 60% pathological overall response rate for combination vs. 36% for CET alone
- In patients with organ-confined disease, 48% pCR rate for combination vs. 23% for CET alone
- 68% of patients with organ-confined disease were downstaged at radical cystectomy

The treatment showed a manageable safety profile, with mostly Grade 1-2 adverse events. These results suggest TAR-200 plus cetrelimab could potentially alter bladder cancer treatment approaches.

Johnson & Johnson (NYSE: JNJ) announced promising results from the Phase 2b SunRISe-1 study of TAR-200 for treating high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Key findings include:

- 83.5% complete response rate in the pivotal Cohort 2 (TAR-200 monotherapy)
- 82% of patients maintained response after a median 9-month follow-up
- Estimated 12-month complete response rate of 57.4%
- Low discontinuation rates due to treatment-resistant adverse events (6% in Cohort 2)

The study also evaluated TAR-200 plus cetrelimab (Cohort 1) and cetrelimab monotherapy (Cohort 3), but results favor TAR-200 monotherapy. These findings support TAR-200's potential as a novel treatment for patients unresponsive to BCG immunotherapy, offering an alternative to radical cystectomy.

Johnson & Johnson (NYSE:JNJ) announced promising results from the Phase 1b/2 OrigAMI-1 study at ESMO 2024. RYBREVANT® (amivantamab-vmjw) combined with chemotherapy showed a 49% overall response rate in RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients who hadn't received anti-EGFR therapy. Key findings include:

- Median duration of response: 7.4 months
- Median progression-free survival: 7.5 months
- Disease control rate: 88%
- 21% of patients proceeded to curative-intent surgery

The safety profile was manageable, with no new safety signals observed. These results suggest RYBREVANT®'s potential beyond lung cancer, particularly in EGFR inhibitor-naïve mCRC patients. Pivotal Phase 3 trials for RYBREVANT®-based regimens in colorectal cancer are planned.

Johnson & Johnson (NYSE:JNJ) announced updated results from the Phase 3 MARIPOSA-2 study at ESMO 2024, showing RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefits in post-progression outcomes for previously treated EGFR-mutated non-small cell lung cancer (NSCLC) patients. The data revealed a favorable trend toward improved overall survival (OS) compared to chemotherapy alone.

Key findings include:

• 50% of patients treated with RYBREVANT® plus chemotherapy were alive at 18 months vs 40% with chemotherapy alone
• Median OS: 17.7 vs 15.3 months (HR: 0.73, P=0.039)
• 22% of patients remained on RYBREVANT® plus chemotherapy at 18 months vs 4% on chemotherapy alone
• Significant improvements in treatment discontinuation rates, time to symptomatic progression, and time to subsequent therapy

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.