Johnson & Johnson's Tremfya Receives FDA Approval for Expanded Indication
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 hours ago
0mins
Source: seekingalpha
- FDA Approval Expansion: Johnson & Johnson's monoclonal antibody therapy Tremfya has received FDA approval to expand its indication to prevent joint damage in psoriatic arthritis patients, showcasing the company's ongoing innovation in immune-mediated diseases.
- Significant Sales Contribution: Tremfya generated $5.2 billion in sales last year, accounting for nearly 6% of J&J's total revenue, indicating the product's importance in the company's overall performance and strong market demand.
- Patient Risk Warning: Research indicates that active psoriatic arthritis patients may begin to experience joint damage as early as six months after onset, with approximately 50% potentially developing irreversible joint damage if left untreated, highlighting the urgency of Tremfya's treatment.
- Clinical Research Support: The FDA approval is supported by data from J&J's Phase 3b APEX study, which demonstrated that Tremfya reduced joint symptoms and inhibited the progression of structural damage compared to placebo, further solidifying its efficacy in treating psoriatic arthritis.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy JNJ?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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: 230.800
Low
190.00
Averages
218.50
High
240.00
Current: 230.800
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.
Regulatory Approvals and Collaborations in Biotech Sector
- FDA Approval for AZN: AstraZeneca (AZN) secured FDA approval for the IMFINZI + BCG combination in high-risk non-muscle-invasive bladder cancer, supported by Phase 3 POTOMAC data showing a 32% reduction in recurrence or death, enhancing its competitive edge in oncology.
- JNJ TREMFYA Label Expansion: Johnson & Johnson (JNJ) received FDA approval to add structural joint-damage inhibition data to the TREMFYA label for active psoriatic arthritis, confirming its unique position in first-line treatment with no new safety signals, reinforcing its market leadership.
- LINZESS Approved for Children: Ironwood Pharmaceuticals (IRWD) gained FDA approval for LINZESS to treat functional constipation in children aged 2-5, based on a 12-week Phase 3 trial showing significant improvement in spontaneous bowel movements, expanding its pediatric market influence.
- AbbVie's DECNUPAZ Approval: AbbVie (ABBV) received FDA approval for DECNUPAZ to treat ultra-rare blood cancer BPDCN, supported by Phase 1 data showing a 69.7% composite complete response rate and a median duration of 9.7 months, marking a significant innovation in hematologic oncology.
See More
Johnson & Johnson Reports Positive Phase 3 Results for TECVAYLI in Multiple Myeloma
- Clinical Trial Success: Johnson & Johnson's MajesTEC-9 study demonstrated that TECVAYLI reduced the risk of disease progression or death by 71% and lowered the risk of death by 40% in patients with relapsed or refractory multiple myeloma, indicating a significant therapeutic advantage over standard care.
- Significant Patient Response: Nearly two-thirds of patients treated with TECVAYLI achieved a complete response or better, compared to only 16.8% of those receiving standard treatment, highlighting TECVAYLI's potential to redefine treatment standards in this patient population.
- Consistent Safety Profile: The safety profile of TECVAYLI was consistent with previous findings, with treatment-emergent adverse events similar to those seen with standard therapies, indicating its acceptability and safety in clinical applications.
- Regulatory Application Progress: Johnson & Johnson is collaborating with global regulators to expand the use of TECVAYLI as a second-line treatment, having already submitted applications to the U.S. FDA and the European Medicines Agency, signaling strong market potential and future growth opportunities.
See More
Mixed Stock Index Futures as Traders Monitor U.S.-Iran Conflict Updates
- UnitedHealth Group Update: UnitedHealthcare plans to eliminate nearly two-thirds of prior authorization requirements for patients under 18 by the end of 2026, enhancing access to diagnostic services and surgical procedures, which is expected to significantly improve patient experience and operational efficiency.
- Autodesk Acquisition Impact: Autodesk's announcement of acquiring MaintainX led to a 7% drop in premarket trading despite beating first-quarter estimates, indicating that while analysts remain positive, the acquisition may have raised concerns about future integration and market positioning.
- Costco Refund Strategy: Costco revealed plans to return tariff refunds to customers during its earnings call, with submissions expected over the next few months, which could impact short-term cash flow and customer satisfaction as the company navigates the refund process.
- Johnson & Johnson Drug Approval: Johnson & Johnson received FDA approval to expand the label for its Tremfya therapy for psoriatic arthritis, which generated $5.2 billion in sales last year, representing nearly 6% of total revenue, and is anticipated to further bolster the company's growth trajectory.
See More
Johnson & Johnson Reports TECVAYLI Data Significantly Improving Survival in Multiple Myeloma Patients
- Clinical Trial Results: Johnson & Johnson's MajesTEC-9 study demonstrates that TECVAYLI® reduces the risk of disease progression or death by 71% and the risk of death by 40% in patients with relapsed or refractory multiple myeloma compared to standard care, highlighting its potential in early treatment.
- Survival Rate Improvement: With 85% of patients being refractory to anti-CD38 monoclonal antibodies, the use of TECVAYLI® significantly enhances progression-free survival (PFS) and overall survival (OS), further solidifying its role in multiple myeloma therapy.
- Safety Profile Analysis: The safety profile of TECVAYLI® aligns with known characteristics, with 99.7% of patients experiencing treatment-emergent adverse events (TEAEs), and 84.9% reporting grade 3/4 adverse events, indicating its acceptability in clinical applications.
- Regulatory Progress: Johnson & Johnson has submitted regulatory approval applications for TECVAYLI® to the FDA and EMA, aiming to position it as an early treatment option for relapsed or refractory multiple myeloma, thus advancing its market application.
See More
New Phase 3 Study Results for TECVAYLI® Show Significant Survival Benefits
- Clinical Trial Results: The MajesTEC-9 study demonstrates that TECVAYLI® reduces the risk of disease progression or death by 71% and the risk of death by 40% in patients with relapsed or refractory multiple myeloma compared to standard care, showcasing significant clinical efficacy.
- Survival Improvement: In a heavily pre-treated population where 85% were refractory to anti-CD38 monoclonal antibodies, TECVAYLI® significantly improved progression-free survival (PFS) and overall survival (OS), reinforcing its potential in earlier lines of treatment.
- Safety Profile: The safety profile of TECVAYLI® aligns with its known characteristics, with treatment-emergent adverse events (TEAEs) occurring in 99.7% of patients, and severe TEAEs reported in 84.9%, indicating good tolerability.
- Regulatory Progress: Following the positive results from MajesTEC-9, Johnson & Johnson has submitted regulatory approval applications for TECVAYLI® to the FDA and EMA, which is expected to facilitate its use in earlier treatment settings.
See More
Johnson & Johnson's Tremfya Receives FDA Approval for Expanded Indication
- FDA Approval Expansion: Johnson & Johnson's monoclonal antibody therapy Tremfya has received FDA approval to expand its indication to prevent joint damage in psoriatic arthritis patients, showcasing the company's ongoing innovation in immune-mediated diseases.
- Significant Sales Contribution: Tremfya generated $5.2 billion in sales last year, accounting for nearly 6% of J&J's total revenue, indicating the product's importance in the company's overall performance and strong market demand.
- Patient Risk Warning: Research indicates that active psoriatic arthritis patients may begin to experience joint damage as early as six months after onset, with approximately 50% potentially developing irreversible joint damage if left untreated, highlighting the urgency of Tremfya's treatment.
- Clinical Research Support: The FDA approval is supported by data from J&J's Phase 3b APEX study, which demonstrated that Tremfya reduced joint symptoms and inhibited the progression of structural damage compared to placebo, further solidifying its efficacy in treating psoriatic arthritis.
See More
Regulatory Approvals and Collaborations in Biotech Sector
- FDA Approval for AZN: AstraZeneca (AZN) secured FDA approval for the IMFINZI + BCG combination in high-risk non-muscle-invasive bladder cancer, supported by Phase 3 POTOMAC data showing a 32% reduction in recurrence or death, enhancing its competitive edge in oncology.
- JNJ TREMFYA Label Expansion: Johnson & Johnson (JNJ) received FDA approval to add structural joint-damage inhibition data to the TREMFYA label for active psoriatic arthritis, confirming its unique position in first-line treatment with no new safety signals, reinforcing its market leadership.
- LINZESS Approved for Children: Ironwood Pharmaceuticals (IRWD) gained FDA approval for LINZESS to treat functional constipation in children aged 2-5, based on a 12-week Phase 3 trial showing significant improvement in spontaneous bowel movements, expanding its pediatric market influence.
- AbbVie's DECNUPAZ Approval: AbbVie (ABBV) received FDA approval for DECNUPAZ to treat ultra-rare blood cancer BPDCN, supported by Phase 1 data showing a 69.7% composite complete response rate and a median duration of 9.7 months, marking a significant innovation in hematologic oncology.
See More
Johnson & Johnson Reports Positive Phase 3 Results for TECVAYLI in Multiple Myeloma
- Clinical Trial Success: Johnson & Johnson's MajesTEC-9 study demonstrated that TECVAYLI reduced the risk of disease progression or death by 71% and lowered the risk of death by 40% in patients with relapsed or refractory multiple myeloma, indicating a significant therapeutic advantage over standard care.
- Significant Patient Response: Nearly two-thirds of patients treated with TECVAYLI achieved a complete response or better, compared to only 16.8% of those receiving standard treatment, highlighting TECVAYLI's potential to redefine treatment standards in this patient population.
- Consistent Safety Profile: The safety profile of TECVAYLI was consistent with previous findings, with treatment-emergent adverse events similar to those seen with standard therapies, indicating its acceptability and safety in clinical applications.
- Regulatory Application Progress: Johnson & Johnson is collaborating with global regulators to expand the use of TECVAYLI as a second-line treatment, having already submitted applications to the U.S. FDA and the European Medicines Agency, signaling strong market potential and future growth opportunities.
See More
Mixed Stock Index Futures as Traders Monitor U.S.-Iran Conflict Updates
- UnitedHealth Group Update: UnitedHealthcare plans to eliminate nearly two-thirds of prior authorization requirements for patients under 18 by the end of 2026, enhancing access to diagnostic services and surgical procedures, which is expected to significantly improve patient experience and operational efficiency.
- Autodesk Acquisition Impact: Autodesk's announcement of acquiring MaintainX led to a 7% drop in premarket trading despite beating first-quarter estimates, indicating that while analysts remain positive, the acquisition may have raised concerns about future integration and market positioning.
- Costco Refund Strategy: Costco revealed plans to return tariff refunds to customers during its earnings call, with submissions expected over the next few months, which could impact short-term cash flow and customer satisfaction as the company navigates the refund process.
- Johnson & Johnson Drug Approval: Johnson & Johnson received FDA approval to expand the label for its Tremfya therapy for psoriatic arthritis, which generated $5.2 billion in sales last year, representing nearly 6% of total revenue, and is anticipated to further bolster the company's growth trajectory.
See More
Johnson & Johnson Reports TECVAYLI Data Significantly Improving Survival in Multiple Myeloma Patients
- Clinical Trial Results: Johnson & Johnson's MajesTEC-9 study demonstrates that TECVAYLI® reduces the risk of disease progression or death by 71% and the risk of death by 40% in patients with relapsed or refractory multiple myeloma compared to standard care, highlighting its potential in early treatment.
- Survival Rate Improvement: With 85% of patients being refractory to anti-CD38 monoclonal antibodies, the use of TECVAYLI® significantly enhances progression-free survival (PFS) and overall survival (OS), further solidifying its role in multiple myeloma therapy.
- Safety Profile Analysis: The safety profile of TECVAYLI® aligns with known characteristics, with 99.7% of patients experiencing treatment-emergent adverse events (TEAEs), and 84.9% reporting grade 3/4 adverse events, indicating its acceptability in clinical applications.
- Regulatory Progress: Johnson & Johnson has submitted regulatory approval applications for TECVAYLI® to the FDA and EMA, aiming to position it as an early treatment option for relapsed or refractory multiple myeloma, thus advancing its market application.
See More
New Phase 3 Study Results for TECVAYLI® Show Significant Survival Benefits
- Clinical Trial Results: The MajesTEC-9 study demonstrates that TECVAYLI® reduces the risk of disease progression or death by 71% and the risk of death by 40% in patients with relapsed or refractory multiple myeloma compared to standard care, showcasing significant clinical efficacy.
- Survival Improvement: In a heavily pre-treated population where 85% were refractory to anti-CD38 monoclonal antibodies, TECVAYLI® significantly improved progression-free survival (PFS) and overall survival (OS), reinforcing its potential in earlier lines of treatment.
- Safety Profile: The safety profile of TECVAYLI® aligns with its known characteristics, with treatment-emergent adverse events (TEAEs) occurring in 99.7% of patients, and severe TEAEs reported in 84.9%, indicating good tolerability.
- Regulatory Progress: Following the positive results from MajesTEC-9, Johnson & Johnson has submitted regulatory approval applications for TECVAYLI® to the FDA and EMA, which is expected to facilitate its use in earlier treatment settings.
See More
Johnson & Johnson's Tremfya Receives FDA Approval for Expanded Indication
- FDA Approval Expansion: Johnson & Johnson's monoclonal antibody therapy Tremfya has received FDA approval to expand its indication to prevent joint damage in psoriatic arthritis patients, showcasing the company's ongoing innovation in immune-mediated diseases.
- Significant Sales Contribution: Tremfya generated $5.2 billion in sales last year, accounting for nearly 6% of J&J's total revenue, indicating the product's importance in the company's overall performance and strong market demand.
- Patient Risk Warning: Research indicates that active psoriatic arthritis patients may begin to experience joint damage as early as six months after onset, with approximately 50% potentially developing irreversible joint damage if left untreated, highlighting the urgency of Tremfya's treatment.
- Clinical Research Support: The FDA approval is supported by data from J&J's Phase 3b APEX study, which demonstrated that Tremfya reduced joint symptoms and inhibited the progression of structural damage compared to placebo, further solidifying its efficacy in treating psoriatic arthritis.
See More
