Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE: JNJ) has published new data in mAbs journal about nipocalimab, their investigational neonatal Fc receptor (FcRn) blocker. The research highlights the drug's selective and high-affinity binding properties in treating IgG-driven alloantibody and autoantibody diseases.

The studies demonstrate that nipocalimab, a fully human IgG-1 monoclonal antibody, can reduce circulating IgG levels by more than 75%, including pathogenic IgG autoantibodies, without affecting IgG production or other immune functions. The drug's pH-independent binding characteristic makes it particularly suitable for investigating alloimmune diseases of pregnancy.

The findings are consistent with clinical Phase 1, 2, and 3 studies of nipocalimab, though clinical significance remains to be determined.

Johnson & Johnson (NYSE: JNJ) has announced its participation in the upcoming 45th Annual TD Cowen Healthcare Conference. The company's management will engage in a fireside chat scheduled for Tuesday, March 4th, 2025, at 11:10 a.m. Eastern Time.

Interested parties can access a live audio webcast of the presentation through Johnson & Johnson's Investor Relations website at www.investor.jnj.com. For those unable to attend the live session, an archived version will be made available later the same day.

Johnson & Johnson (NYSE: JNJ) announced the publication of Phase 3 study results for nipocalimab in The Lancet Neurology. The study focused on treating generalized myasthenia gravis (gMG) in antibody-positive adults. The trial met its primary endpoint, showing significant improvement in MG-ADL scores over 24 weeks.

Key findings include up to 75% reduction in median pre-dose total IgG from baseline, with sustained disease control over 24 weeks. The therapy demonstrated a tolerable safety profile, with discontinuation rates similar to placebo (5.1% vs 7.1%). Nipocalimab received FDA Priority Review and was recently granted Breakthrough Therapy Designation for Sjögren's disease treatment.

The company submitted Biologics License Application (BLA) to FDA and Marketing Authorisation Application (MAA) to EMA in August and September 2024, respectively, seeking approval for gMG treatment.

Johnson & Johnson (JNJ) reported strong Q4 2024 results with sales growth of 5.3% to $22.5 Billion. The company achieved full-year 2024 sales of $88.8 Billion, representing a 4.3% growth. Q4 earnings per share (EPS) was $1.41, while adjusted EPS reached $2.04, both including a $(0.22) impact from acquired IPR&D charges.

For the full year 2024, JNJ posted EPS of $5.79 and adjusted EPS of $9.98. The company's performance was driven by strong growth in both Innovative Medicine and MedTech segments. Innovative Medicine saw operational sales growth of 7.5% (excluding COVID-19 Vaccine), while MedTech achieved 6.2% operational growth.

Looking ahead, JNJ provided 2025 guidance with operational sales growth projected at 2.5-3.5% and adjusted operational EPS of $10.75-$10.95, representing strong growth of 8.7% at the mid-point.

Johnson & Johnson (NYSE: JNJ) announced FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression. The approval follows FDA Priority Review and is based on clinical data showing superior improvement in depressive symptoms compared to placebo as early as 24 hours.

Key findings show that at week 4, 22.5% of SPRAVATO® patients achieved remission compared to 7.6% for placebo. The treatment demonstrated improvements across all 10 MADRS (Montgomery-Asberg Depression Rating Scale) items at day 28. The safety profile remained consistent with existing clinical data, with no new concerns identified.

This breakthrough addresses a significant medical need, as approximately one-third of the estimated 21 million U.S. adults with major depressive disorder (MDD) do not respond to oral antidepressants alone. SPRAVATO® has been administered to over 140,000 patients worldwide and is available through a restricted REMS Program due to potential risks.

Johnson & Johnson (NYSE: JNJ) has initiated a New Drug Application with the FDA for TAR-200, the first intravesical drug releasing system for BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC). The application is being reviewed under the FDA's Real-Time Oncology Review program, based on impressive Phase 2b SunRISe-1 study results showing an 83.5% complete response rate.

The study demonstrated strong durability, with 82% of responders maintaining response at a median follow-up of nine months. Safety data revealed low occurrence (9%) of Grade 3 or higher treatment-related adverse events, with only 6% of patients discontinuing due to adverse events and no treatment-related deaths reported.

TAR-200 delivers gemcitabine directly into the bladder through a quick outpatient procedure requiring no anesthesia. The FDA granted Breakthrough Therapy Designation to TAR-200 in December 2023 for treating adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have declined radical cystectomy.

Dean Omar Branham Shirley partners Jessica Dean and Trey Branham have been named to Lawdragon's 500 Leading Lawyers in America for 2025. The recognition follows a successful 2024, during which the firm secured multiple significant verdicts, including a notable $45 million jury verdict against Johnson & Johnson (NYSE: JNJ) in Chicago.

Jessica Dean specializes in representing mesothelioma victims affected by asbestos exposure, having secured millions in jury verdicts. Trey Branham is recognized for his excellence in plaintiff consumer litigation and decades of plaintiff-side personal injury work. The Lawdragon guide features rigorously vetted attorneys who demonstrate excellence in their legal practice.

Johnson & Johnson (JNJ) has announced the acquisition of Intra-Cellular Therapies for $132.00 per share in cash, totaling approximately $14.6 billion. The acquisition includes CAPLYTA® (lumateperone), an FDA-approved treatment for bipolar I and II depression and schizophrenia in adults.

CAPLYTA® has potential peak year sales exceeding $5 billion and is currently under FDA review for major depressive disorder (MDD) treatment. The drug demonstrated significant improvement in depressive symptoms in Phase 3 trials as an adjunctive treatment to antidepressants.

The deal also includes ITI-1284, a Phase 2 compound being studied for generalized anxiety disorder and Alzheimer's disease-related conditions. The transaction is expected to close later this year, subject to regulatory approvals and stockholder approval.

Johnson & Johnson (NYSE: JNJ) announced that nipocalimab has received FDA Priority Review designation for treating antibody positive patients with generalized myasthenia gravis (gMG). The designation is supported by the Phase 3 Vivacity-MG3 study results, which showed sustained disease control over 24 weeks in patients with anti-AChR, anti-MuSK, and anti-LRP4 antibodies.

The study demonstrated that nipocalimab plus standard of care achieved a significantly greater reduction in MG-ADL response compared to placebo (p=0.0213). gMG affects approximately 700,000 people worldwide and currently has no cure. The company has also submitted a Marketing Authorisation Application to the EMA for nipocalimab in gMG on September 11, 2024.

Additionally, nipocalimab recently received FDA Breakthrough Therapy Designation for treating adults with moderate-to-severe Sjögren's disease, based on Phase 2 DAHLIAS study results.