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TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years
Prnewswire· 2026-02-21 13:00
Core Insights - Johnson & Johnson announced long-term data from the QUASAR study showing that TREMFYA® (guselkumab) maintains clinical and endoscopic remission in ulcerative colitis patients over three years, with over 80% of patients in clinical remission and more than 50% in endoscopic remission at Week 140 [1][2]. Group 1: Clinical Efficacy - At Week 140, 80.8% of patients treated with TREMFYA® were in clinical remission, while 53.6% achieved endoscopic remission [1]. - 78.6% of patients experienced histo-endoscopic mucosal improvement (HEMI), indicating significant intestinal healing [1]. - Among those in clinical remission at Week 44, 87.5% maintained remission through Week 140, demonstrating sustained efficacy [1]. Group 2: Study Retention and Safety - Approximately 89% of eligible study participants completed treatment through Week 140, indicating high retention rates [1]. - No new safety concerns were reported during the study, reinforcing the long-term safety profile of TREMFYA® [1][2]. Group 3: Mechanism and Approval - TREMFYA® is the first and only approved dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, targeting immune-mediated diseases [1][2]. - The drug has received FDA and European Commission approval for treating both moderately to severely active Crohn's disease and ulcerative colitis [1][2]. Group 4: Additional Research and Commitment - Johnson & Johnson presented 30 abstracts at the European Crohn's and Colitis Organisation (ECCO) 2026 conference, highlighting ongoing research and commitment to inflammatory bowel disease treatments [1]. - Two other abstracts from Johnson & Johnson were recognized as Top 10 oral abstracts, showcasing the company's dedication to advancing treatment options [1].
Protagonist Therapeutics, Inc. (PTGX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-13 22:35
Core Insights - Protagonist Therapeutics is poised for significant growth and value creation over the next 12 to 24 months, driven by two potential blockbuster drug approvals and launches, multiple clinical readouts, new discovery programs, and a strong cash position [3] Company Overview - Protagonist Therapeutics is participating in the 44th JPMorgan Healthcare Conference for the sixth consecutive year, indicating its established presence in the biotech sector [2] - The company is focused on completing a decade-long journey from concept to commercialization with two specific assets: icotrokinra, partnered with Johnson & Johnson, and rusfertide, partnered with Takeda [3] Development Pipeline - The company is highlighting its development candidates that target validated biological pathways, with differentiated assets aimed at addressing specific unmet medical needs across multiple indications [4]
Can J&J's Pipeline Progress in 2025 Aid Long-Term Growth?
ZACKS· 2025-12-26 14:26
Core Insights - Johnson & Johnson (J&J) has a strong R&D pipeline focused on immunology, oncology, and neuroscience, with significant advancements in 2025 [1][2][8] Pipeline and Product Approvals - J&J has achieved major clinical and regulatory milestones, including approvals for Inlexzoh/TAR-200 for high-risk non-muscle invasive bladder cancer and Imaavy (nipocalimab) for generalized myasthenia gravis [2][11] - Nipocalimab is being evaluated for various immune-mediated conditions and is considered to have pipeline-in-a-product potential [3] - Regulatory applications for icotrokinra, an oral treatment for moderate-to-severe plaque psoriasis, have been filed in the US and EU [4] - J&J's new cancer drugs, including Carvykti, Tecvayli, and Talvey, generated $2.14 billion in sales in the first nine months of 2025 [5][11] Strategic Acquisitions and Expansions - The acquisition of Intra-Cellular Therapies added Caplyta, an antidepressant, to J&J's neuroscience portfolio [6] - J&J aims to expand the indications of currently marketed products, with recent approvals for Tremfya, Rybrevant, and Caplyta [7] Long-term Growth Potential - J&J's pipeline execution and recent product approvals position the company for sustained growth beyond short-term pressures, with multiple late-stage assets and significant sales potential across its Innovative Medicine portfolio [8] Competitive Landscape - J&J faces competition in the oncology space from major players like Pfizer, AstraZeneca, Merck, and Bristol-Myers, each with strong oncology portfolios and growth in sales [9][10][12][13][14] Financial Performance and Valuation - J&J's shares have outperformed the industry, rising 42.8% over the past year compared to a 17.5% increase for the industry [15] - The company's shares trade at a price/earnings ratio of 18.09, slightly above the industry average of 17.59 and its five-year mean of 15.65 [18] - The Zacks Consensus Estimate for 2025 earnings has increased from $10.86 to $10.87 per share, indicating positive earnings revisions [20]
Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera
Businesswire· 2025-12-06 14:30
Core Insights - Protagonist Therapeutics and Takeda announced new 52-week results from the Phase 3 VERIFY study, highlighting the efficacy and safety of rusfertide in treating polycythemia vera (PV) patients, with 61.9% of patients maintaining absence of phlebotomy eligibility from baseline to Week 52 [1][2] Efficacy and Safety - The 52-week data demonstrated sustained efficacy of rusfertide, significantly reducing the need for phlebotomy while maintaining hematocrit control [2] - 61.9% of patients treated with rusfertide maintained a durable clinical response, defined as absence of phlebotomy eligibility [4] - 84.1% of patients who had a clinical response in the Part 1a assessment maintained their response [4] - The median time to first phlebotomy was not reached in the rusfertide group, indicating effective treatment [4] Patient Outcomes - Patients treated with rusfertide reported improvements in quality of life, as measured by PROMIS Fatigue SF-8 and MFSAF TSS [4] - The mean hematocrit remained below 43% through Week 52 for patients treated with rusfertide [4] - Serious adverse events occurred in 8.1% of rusfertide-treated patients, indicating a generally well-tolerated safety profile [5] Long-term Study Insights - The THRIVE study showed a greater than 13-fold reduction in the estimated annual therapeutic phlebotomy rate compared to baseline, with a mean annualized phlebotomy rate dropping from 9.2 to 0.7 phlebotomies/year [6] - The THRIVE study is designed to assess the long-term durability of response and safety profile of rusfertide over an additional two-year treatment period [10] Regulatory and Development Status - Rusfertide has received Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation from the FDA, indicating its potential as a significant treatment option for PV [7] - The Phase 3 VERIFY study is ongoing, evaluating rusfertide in 293 patients over a 156-week period [8]
Johnson & Johnson (JNJ) Presents at 7th Annual Wolfe Research Healthcare Conference Transcript
Seeking Alpha· 2025-11-17 18:17
Core Insights - The company is preparing for the potential launch of icotrokinra, a targeted oral peptide for psoriasis treatment, which is seen as a transformative next-generation therapy [1][2] - Icotrokinra is the only asset that offers a combination of complete skin clearance, favorable safety, and the convenience of a once-daily pill [1] - The development program for icotrokinra has been robust, supporting its position as a first-line systemic therapy for psoriasis based on large Phase III study data [2]
Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis
Prnewswire· 2025-10-27 11:30
Core Insights - Icotrokinra, a first-in-class targeted oral peptide developed by Johnson & Johnson, has shown promising results in the Phase 2b ANTHEM-UC study for treating moderately to severely active ulcerative colitis, with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement at Week 28 compared to placebo [1][2][3] Clinical Results - At Week 28, all doses of icotrokinra (100 mg, 200 mg, and 400 mg) demonstrated higher rates of clinical response, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI) compared to placebo [1][2] - The clinical response rates for the 400 mg dose were 66.7% at Week 28, up from 63.5% at Week 12, while clinical remission improved from 30.2% to 31.7% [2] - Endoscopic improvement increased from 36.5% at Week 12 to 38.1% at Week 28, with HEMI rates rising from 28.6% to 33.1% [2] Safety Profile - Similar proportions of participants reported adverse events and serious adverse events across all icotrokinra dose groups and the placebo group, indicating a favorable safety profile [2][3] Future Development - Johnson & Johnson has initiated Phase 3 clinical development for icotrokinra in both adults and adolescents with moderately to severely active ulcerative colitis and Crohn's disease [3] - The company is also studying icotrokinra in pivotal Phase 3 programs for moderate-to-severe plaque psoriasis and active psoriatic arthritis [3][9] Mechanism of Action - Icotrokinra is designed to precisely block the IL-23 receptor, which plays a critical role in the inflammatory response associated with ulcerative colitis and other IL-23-mediated diseases [8][9] Regulatory Status - A New Drug Application (NDA) for icotrokinra was submitted to the U.S. Food and Drug Administration (FDA) in July 2025, seeking approval for treating adults and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis [3]
Icotrokinra long-term results affirm promise of targeted oral peptide with high rates of durable skin clearance and favorable safety profile in difficult-to-treat scalp and genital psoriasis
Prnewswire· 2025-10-24 12:00
Core Insights - Johnson & Johnson announced long-term data from the Phase 3 ICONIC-TOTAL study, showing that icotrokinra, a targeted oral peptide, effectively treats moderate-to-severe plaque psoriasis in adults and adolescents, achieving high rates of skin clearance [1][4][5]. Efficacy and Safety - In the ICONIC-TOTAL study, 72% of patients with scalp psoriasis and 85% with genital psoriasis achieved clear or almost clear skin at Week 52 [1][6]. - Overall, 67% of patients treated with icotrokinra achieved clear or almost clear skin by Week 24, maintaining this through Week 52 [1][4]. - In patients with hand/foot psoriasis, the rate of skin clearance increased from 42% at Week 16 to 62% at Week 52 [3]. Patient Impact - The study highlights the significant distress experienced by patients when psoriasis affects sensitive areas, indicating icotrokinra's potential as a meaningful treatment option for managing moderate-to-severe plaque psoriasis long-term [4][5]. - The treatment demonstrated comparable response rates between patients who received icotrokinra for the full 52 weeks and those who transitioned from placebo at Week 16 [4]. Clinical Development - The ICONIC clinical development program includes multiple studies evaluating icotrokinra's efficacy and safety across various conditions, including plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease [10][11][16]. - Icotrokinra is designed to precisely block the IL-23 receptor, which is crucial in the inflammatory response associated with these diseases [13][16]. Conclusion - The long-term data from the ICONIC-TOTAL study reinforces icotrokinra's potential to set a new standard of treatment for patients with high-impact psoriasis, combining effective skin clearance with a favorable safety profile [5][12].
Johnson & Johnson's M&A Strategy Is the Real Story for Investors
MarketBeat· 2025-10-18 16:04
Core Insights - Johnson & Johnson is pursuing a disciplined acquisition strategy aimed at long-term growth and innovation, rather than short-term stock price increases [1][2] - The company is actively reshaping its portfolio by divesting slower-growth assets to focus on higher-growth opportunities [2][4] Acquisition Strategy - The spinoff of Kenvue and the planned separation of the Orthopedics business, projected to generate approximately $9.2 billion in sales in 2024, are key steps in this strategy [3][4] - Johnson & Johnson's financial health is strong, with approximately $14 billion in free cash flow generated in the first three quarters of 2025, providing capital for acquisitions [4] Recent Acquisitions - Recent acquisitions in MedTech and Innovative Medicine have shown positive results, contributing to immediate growth and validating the company's capital deployment strategy [6][13] - The acquisition of Intra-Cellular Therapies, which brought in the drug CAPLYTA, has already generated $240 million in sales in the third quarter, highlighting the effectiveness of the M&A strategy [13] M&A Methodology - Johnson & Johnson employs a "partner, validate, acquire" approach, which reduces investment risk by confirming an asset's clinical potential before full acquisition [10][11] - The potential acquisition of Protagonist Therapeutics is a case study of this disciplined M&A playbook, focusing on a clinically validated asset [8][9] Financial Performance - The Cardiovascular unit has seen an impressive 11.6% operational growth in the third quarter of 2025, attributed to successful acquisitions [13] - The company's dividend yield stands at 2.69%, with a history of 64 consecutive years of dividend increases, supported by strong cash flows from integrated acquisitions [15][17] Future Outlook - Management has indicated that they do not require large M&A to meet growth targets, reinforcing confidence in the current pipeline and strategy [16] - Analysts maintain a moderate buy rating for Johnson & Johnson, with a 12-month stock price forecast of $199.59, indicating a potential upside of 3.27% [8]
超40亿美元!强生拟收购Protagonist
Xin Lang Cai Jing· 2025-10-17 04:30
Core Insights - Johnson & Johnson is in talks to acquire its immunotherapy partner Protagonist Therapeutics for over 28.5 billion RMB (approximately 4 billion USD) [1] - The key asset in this acquisition is the oral cyclic peptide IL-23 inhibitor icotrokinra, which is expected to change the treatment landscape for psoriasis [1] Group 1: Acquisition Details - The two companies are currently collaborating on the development of icotrokinra for treating plaque psoriasis and ulcerative colitis [2] - Johnson & Johnson holds exclusive commercialization rights for icotrokinra [2] - The acquisition would help Johnson & Johnson strengthen its product line as its blockbuster immunotherapy drug Stelara recently lost patent exclusivity in the U.S. [2] Group 2: Drug Development Progress - Icotrokinra has shown success in two Phase 3 trials for plaque psoriasis [4] - Johnson & Johnson's CEO stated that if approved, icotrokinra would have a significant market impact [4] - The companies are also looking to expand icotrokinra's application to other immune and inflammatory diseases, with successful results reported in a Phase 2b trial for ulcerative colitis [4] Group 3: Drug Mechanism - Icotrokinra is a targeted oral peptide that selectively blocks the IL-23 receptor (IL-23R), which plays a critical role in the activation of pathogenic T cells in moderate to severe plaque psoriasis [6] - The drug binds with high affinity to IL-23R and exerts strong selective inhibition of IL-23 signaling in human T cells [6] Group 4: Company Background - Johnson & Johnson, founded in 1886, is one of the most comprehensive and widely distributed healthcare product companies globally, with operations in medical technology and innovative pharmaceuticals [7] - In 2023, Johnson & Johnson successfully completed the spin-off of its consumer health business and announced a brand refresh, consolidating its medical technology and innovative pharmaceuticals under the Johnson & Johnson name [7]
Douglas Lane Adds $6 Million in J&J Stock Ahead of Earnings and Possible Biotech Deal
The Motley Fool· 2025-10-12 19:14
Core Insights - Douglas Lane & Associates disclosed a purchase of 34,948 shares of Johnson & Johnson, valued at approximately $6 million based on average prices during the third quarter [1][2] - The new stake totals 667,373 shares, with a reported market value of $123.7 million at quarter-end [2] - Johnson & Johnson shares were priced at $190.72, reflecting an 18% increase over the past year, outperforming the S&P 500's 12% gain [3] Financial Performance - Johnson & Johnson reported revenue of $90.6 billion and net income of $22.7 billion for the trailing twelve months [4] - The company has a dividend yield of 2.7% [4] - Last quarter, Johnson & Johnson achieved $23.7 billion in sales, marking a nearly 6% year-over-year increase, with net earnings rising 18% to $5.5 billion [8] Business Overview - Johnson & Johnson operates through a diversified portfolio that includes pharmaceuticals, medical devices, and consumer health products, featuring well-known brands such as Tylenol and Neutrogena [9] - The company's business model focuses on research, development, manufacturing, and global distribution of healthcare products across its three core segments [9] - Primary customers include hospitals, healthcare professionals, retailers, wholesalers, and the general public, with a global reach in both prescription and over-the-counter markets [9] Strategic Developments - Douglas Lane & Associates' investment may indicate confidence ahead of Johnson & Johnson's upcoming third-quarter earnings report, with analysts expecting revenue of about $23.7 billion and earnings of $2.77 per share [7] - Johnson & Johnson is reportedly in talks to acquire Protagonist Therapeutics, which could enhance its immunology pipeline, particularly as its leading product, Stelara, faces market share challenges [11]