Johnson & Johnson Stock Price, News & Analysis

Johnson & Johnson has received FDA approval for IMAAVY™ (nipocalimab-aahu), a groundbreaking FcRn blocker for treating generalized myasthenia gravis (gMG). The treatment is approved for both adult and pediatric patients aged 12 and older who are anti-AChR or anti-MuSK antibody positive, covering over 90% of antibody-positive gMG patients.

Key highlights from clinical trials:

• Demonstrated 20 months of lasting disease control and symptom relief
• Reduced harmful IgG autoantibody levels by up to 75% from first dose
• Showed superior disease control over 24 weeks compared to placebo
• Maintained consistent safety profile in both adult and pediatric populations

Through the IMAAVY withMe program, commercially insured U.S. patients may receive their first treatment within one week and could pay as little as $0 per infusion. The approval follows FDA Priority Review designation and represents a significant advancement in gMG treatment options.

Johnson & Johnson (NYSE: JNJ) has announced its upcoming participation in Bernstein's 41st Annual Strategic Decisions Conference. The event will take place on Wednesday, May 28th, 2025, featuring a Fireside Chat session scheduled for 10:00 a.m. Eastern Time.

Key Details:

• The presentation will be accessible through a live audio webcast
• Investors can access the webcast via www.investor.jnj.com
• An archived version will be available later the same day
• Audio webcast replay will be accessible approximately 48 hours after the event

This conference participation demonstrates Johnson & Johnson's commitment to maintaining transparent communication with investors and analysts. The format of a Fireside Chat suggests an informal, conversational approach to discussing company strategies and developments.

Johnson & Johnson (NYSE: JNJ) announced promising first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system for bladder cancer treatment. The study demonstrated:

• Over 80% disease-free survival (DFS) rate without reinduction
• 94% of patients preserved their bladder, avoiding radical cystectomy
• 85.3% and 81.1% DFS rates at six and nine months respectively
• 95.6% progression-free survival rate at 9 months

Among 52 enrolled patients, TAR-200's safety profile showed mostly low-grade, quickly resolving treatment-related adverse events. Common side effects included dysuria (40.4%), pollakiuria (30.8%), and urgency (26.9%). The results support continued evaluation in the ongoing Phase 3 SunRISe-5 study comparing TAR-200 to chemotherapy in BCG-pretreated patients.

Johnson & Johnson (JNJ) announced promising new data from Phase 2b SunRISe-1 study of TAR-200, an intravesical gemcitabine releasing system for bladder cancer treatment. The study showed remarkable results with 82.4% of 85 enrolled patients achieving complete response, and 52.9% of responders maintaining cancer-free status at one year.

The median duration of response was 25.8 months, with 86.6% of responders remaining cystectomy-free at 12 months. The treatment demonstrated strong safety profile, with mostly mild urinary symptoms reported. Of the 83.5% patients experiencing treatment-related adverse events, only 12.9% reported Grade 3 or higher events.

TAR-200, administered through a brief outpatient procedure, represents a potential breakthrough for patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer. The company has initiated a new drug application with the FDA under the Real-Time Oncology Review program in January 2025.

Johnson & Johnson (NYSE: JNJ) has revealed groundbreaking data for its TAR-200 bladder cancer treatment at the AUA 2025 Annual Meeting. The Phase 2b SunRISe-1 study demonstrated the highest complete response with sustained benefits in treating high-risk non-muscle invasive bladder cancer (HR-NMIBC).

TAR-200, an intravesical gemcitabine releasing system, has shown promising results for patients with BCG-unresponsive HR-NMIBC. The treatment is administered directly into the bladder through a brief outpatient procedure, requiring no anesthesia. To date, TAR-200 has been placed over 10,000 times in clinical trials.

The presentation highlights include 12-month duration response data from Cohort 2 and first results from Cohort 4 of the Phase 2b SunRISe-1 study. This innovation represents a significant advancement in bladder cancer treatment, which has remained largely unchanged for over 40 years, potentially offering a new bladder-sparing option for the nearly one million people affected by bladder cancer annually.

Johnson & Johnson (NYSE: JNJ) has announced its participation in the upcoming 2025 RBC Capital Markets Global Healthcare Conference. The company's management will engage in a Fireside Chat scheduled for Tuesday, May 20th at 1:35 p.m. Eastern Time.

The event will feature a live audio webcast accessible to investors and interested parties through the company's investor relations website at www.investor.jnj.com. A replay of the webcast will be made available approximately 48 hours after the event.

Johnson & Johnson (NYSE: JNJ) has announced a 4.8% increase in its quarterly dividend from $1.24 to $1.30 per share, marking its 63rd consecutive year of dividend increases. The new annual dividend rate will be $5.20 per share, up from the previous $4.96 per share.

The next quarterly dividend will be payable on June 10, 2025, with a record date and ex-dividend date of May 27, 2025.

Johnson & Johnson (JNJ) reported strong Q1 2025 results with reported sales growth of 2.4% to $21.9 billion and operational growth of 4.2%. The company's adjusted EPS increased by 2.2% to $2.77.

Key highlights include significant pipeline progress with TREMFYA approval in Crohn's disease, positive data for RYBREVANT/LAZCLUZE in lung cancer, and the initiation of OTTAVA robotic system trials. The company completed the Intra-Cellular Therapies acquisition and increased its Full-Year 2025 operational sales guidance.

Segment performance showed Innovative Medicine sales growing 4.2% operationally to $13.87 billion, driven by DARZALEX, CARVYKTI, and other products, while MedTech sales grew 4.1% operationally to $8.02 billion. U.S. sales increased by 5.9% to $12.3 billion, while international sales showed operational growth of 2.1%.

Johnson & Johnson (NYSE: JNJ) announced promising Phase 3 trial results for icotrokinra (JNJ-2113), a first-in-class investigational oral peptide for moderate-to-severe plaque psoriasis. The ICONIC-LEAD study, the first to simultaneously assess a systemic therapy in both adolescents and adults, showed remarkable efficacy in adolescent patients.

Key findings at Week 16 showed 84.1% of adolescent patients achieved clear or almost clear skin (IGA 0/1), compared to 27.3% for placebo. By Week 24, results improved further with 86.4% achieving IGA 0/1, and notably, 75% achieving completely clear skin (IGA 0).

The drug demonstrated a favorable safety profile, with 50% of adolescents experiencing ≥1 adverse event compared to 73% in the placebo group. The study involved 684 participants, including 66 adolescents, marking a significant advancement in psoriasis treatment options for younger patients.