Johnson & Johnson Stock Price, News & Analysis

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.

Johnson & Johnson (NYSE: JNJ) has received FDA Fast Track designations for two Alzheimer's disease treatments: posdinemab and JNJ-2056. Posdinemab, a phosphorylated tau-directed monoclonal antibody, is being investigated in the Phase 2b 'AuTonomy' study for early Alzheimer's disease treatment. The antibody has demonstrated potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated AD patients.

JNJ-2056, the first active immunotherapy targeting tau in a preclinical AD population, received its Fast Track designation in July 2024. It is currently being evaluated in the Phase 2b 'ReTain' trial to assess its potential in generating antibodies against pathological phosphorylated tau, aiming to delay or prevent symptom onset.

These developments are significant as Alzheimer's disease affects approximately 55 million people globally, accounting for 60-80% of dementia cases.

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.