Johnson & Johnson expands FDA filing for tremfya label in psoriatic arthritis
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 29 2025
0mins
Johnson & Johnson's FDA Submission: Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA to update the tremfya label, aiming to include new evidence regarding its effectiveness in inhibiting structural damage progression in adults with active psoriatic arthritis (PsA).
APEX Study Results: The submission is backed by results from the Phase 3b APEX study, which demonstrated that tremfya significantly reduced joint symptoms and inhibited structural damage progression compared to placebo, while maintaining a consistent safety profile.
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Analyst Views on JNJ
Wall Street analysts forecast JNJ stock price to fall
20 Analyst Rating
13 Buy
7 Hold
0 Sell
Moderate Buy
Current: 225.330
Low
190.00
Averages
218.50
High
240.00
Current: 225.330
Low
190.00
Averages
218.50
High
240.00
About JNJ
Johnson & Johnson and its subsidiaries are engaged in the research and development, manufacture, and sale of a range of products in the healthcare field. The Company’s segments include Innovative Medicine and MedTech. The Innovative Medicine segment is focused on various therapeutic areas, including immunology, infectious diseases, neuroscience, oncology, pulmonary hypertension, cardiovascular and metabolism. Its products include REMICADE (infliximab), SIMPONI (golimumab), SIMPONI ARIA (golimumab), STELARA (ustekinumab), TREMFYA (guselkumab), EDURANT (rilpivirine), and INVEGA SUSTENNA/XEPLION (paliperidone palmitate). The MedTech segment includes a portfolio of products used in cardiovascular, orthopedics, surgery, and vision categories. The Cardiovascular portfolio includes electrophysiology products to treat heart rhythm disorders and circulatory restoration products (Shockwave) for the treatment of calcified coronary artery disease (CAD) and peripheral artery disease (PAD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Reduced Metastasis Risk: The combination therapy also achieved a 20% reduction in the risk of metastasis or death, extending the time before patients required subsequent therapy to over six years, which greatly enhances long-term patient outcomes.
- Optimizing Treatment Window: The study suggests that early integration of apalutamide may reshape prostate cancer treatment, highlighting the importance of using systemic therapy before and after surgery to improve cure rates and reduce the need for subsequent therapies.
- Safety and Tolerability: While the safety profile of apalutamide combined with hormone therapy aligns with previous studies, attention must be paid to the incidence of adverse events such as hot flushes (63.4%) and urinary incontinence (50.2%), ensuring patient safety during treatment.
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See More
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- Clinical Trial Results: Johnson & Johnson's PROTEUS study reveals that patients receiving apalutamide combined with hormone therapy had a pathologic complete response rate of 8.9%, significantly higher than the 1.0% for hormone therapy alone, indicating the effectiveness of this combination in high-risk prostate cancer patients.
- Reduced Metastasis Risk: The combination therapy also achieved a 20% reduction in the risk of metastasis or death, extending the time before patients required subsequent therapy to over six years, which greatly enhances long-term patient outcomes.
- Optimizing Treatment Window: The study suggests that early integration of apalutamide may reshape prostate cancer treatment, highlighting the importance of using systemic therapy before and after surgery to improve cure rates and reduce the need for subsequent therapies.
- Safety and Tolerability: While the safety profile of apalutamide combined with hormone therapy aligns with previous studies, attention must be paid to the incidence of adverse events such as hot flushes (63.4%) and urinary incontinence (50.2%), ensuring patient safety during treatment.
See More
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- AI Adoption Scores: A new study from the AI-Driven Enterprise Institute reveals that Nvidia, Meta, and Schlumberger lead S&P 500 companies with perfect scores of 100, showcasing their exceptional performance in AI technology implementation and solidifying their market leadership in their respective industries.
- Industry Impact: Nvidia, as the world's largest chipmaker, drives technological advancements across the industry through its pivotal role in AI model and service development, while Meta and Amazon demonstrate strong AI application capabilities in communication services and consumer goods, enhancing customer experience and operational efficiency.
- Data-Driven Assessment: The study employs publicly available data such as earnings calls, job openings, and patent applications to objectively evaluate executives' understanding and prioritization of AI, aiding companies in better risk management and investment decisions to enhance overall competitiveness.
- Room for Improvement: Despite the strong performance of leading companies, AIDE's CEO Paul Cheek emphasizes that there is significant room for improvement in AI literacy among board members and executives, highlighting the importance of understanding AI's role in creating value for informed strategic investments in the future.
See More
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- AI Adoption Scores: The new index from the AI-Driven Enterprise Institute reveals that Nvidia, Amazon, Meta, and Schlumberger lead S&P 500 companies with perfect scores of 100, indicating their forefront position in AI application and implementation, which may further solidify their market dominance.
- Transparent Research Methodology: The index utilizes publicly available data such as earnings call transcripts, job openings, and patent applications, providing an objective comparison tool that allows companies to assess their AI strategies against peers, thereby facilitating more effective decision-making.
- Significant Industry Disparities: While tech companies excel, the study highlights that many firms have considerable room for improvement in AI literacy and implementation, underscoring the necessity for boards and executives to better understand and manage AI-related risks and strategic investments.
- Top 20 Companies: The top 20 companies based on orientation and implementation scores include Nvidia, Schlumberger, Amazon, and Meta, showcasing their leadership positions within their respective sectors, which may attract increased investor interest in their future growth potential.
See More
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- Clinical Trial Results: Johnson & Johnson's experimental subcutaneous formulation of amivantamab achieved a confirmed overall response rate of 42% in head and neck cancer patients, with over one-third of responders experiencing complete responses, indicating potential efficacy after existing treatments fail.
- Duration of Response: The median duration of response has not yet been reached after nearly 12 months of follow-up, suggesting that the treatment may offer durable effects, enhancing its competitive position in the oncology market.
- Market Opportunity: With the submission of a supplemental Biologics License Application to the FDA, the new indication for amivantamab could broaden its commercial opportunities, particularly in the limited treatment landscape of head and neck cancer, further solidifying Johnson & Johnson's strategic positioning.
- Evaluation Across Cancers: Johnson & Johnson is also evaluating amivantamab across various cancer types, including lung and colorectal cancers, aiming to expand the drug's application to multiple tumor types and enhance its market potential.
See More
Earnings Reports and Tech Conferences This Week
- Earnings Reports: This week, Palo Alto Networks, CrowdStrike, and Broadcom are set to report earnings, with Palo Alto expected to post $0.80 per share on $2.94 billion in revenue, while CrowdStrike is projected to report $1.07 per share on $1.36 billion, highlighting strong market interest in cybersecurity.
- AI-Driven Market Rebound: As AI technology becomes more prevalent, both Palo Alto and CrowdStrike have seen their stock prices rebound to all-time highs, and despite facing high valuation pressures, market expectations for their future performance remain optimistic, making management's outlook a key focus for investors.
- Tech Conference Highlights: Nvidia, Arm, and Microsoft will discuss AI-related topics at tech conferences this week, with Nvidia CEO Jensen Huang scheduled to deliver a keynote on Monday, where he is expected to unveil a new product, potentially personal computers powered by its GPUs, further boosting its market share.
- Labor Market Data: The JOLTS report will be released this week, with expectations of 120,000 new private sector jobs added in May and an unemployment rate holding steady at 4.3%, reflecting economic resilience, and investors will closely monitor these figures for their potential impact on inflation and monetary policy.
See More
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- Clinical Trial Results: Johnson & Johnson's final analysis of the PROTEUS study reveals that the apalutamide plus hormone therapy regimen significantly improves both short- and long-term outcomes for patients with high-risk localized or locally advanced prostate cancer, achieving all primary endpoints.
- Significant Efficacy: Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at surgery compared to those receiving hormone therapy alone (8.9% vs. 1.0%), while also reducing the risk of metastasis or death by 20% and extending the time before subsequent therapy was needed to over six years.
- Survival Rate Improvement: At a median follow-up of 61.7 months, the pathological complete response rate for apalutamide plus hormone therapy was 8.9%, compared to just 1.0% for hormone therapy alone, with five-year metastasis-free survival rates improving from 73.5% to 78.2%, indicating a statistically significant benefit.
- Favorable Safety Profile: The safety profile of apalutamide plus hormone therapy was consistent with previous studies, further supporting its potential role in reshaping treatment for high-risk localized and locally advanced prostate cancer, particularly in enhancing patient quality of life and extending survival.
See More
