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JNJ Stock Surge Signals Confidence in New Growth Path
MarketBeat· 2025-08-25 11:27
Johnson & Johnson TodayJNJJohnson & Johnson$179.10 +0.17 (+0.09%) 52-Week Range$140.68▼$181.16Dividend Yield2.90%P/E Ratio19.15Price Target$176.29Add to WatchlistJohnson & Johnson’s NYSE: JNJ stock chart is sending a clear signal that contrasts sharply with the persistent hum of repetitive negative headlines. While news cycles continue to circle long-running legal battles, the company’s market performance paints a picture of investor confidence, with its stock climbing over 23% year-to-date. This growing d ...
JNJ Seeks FDA Approval for Oral Psoriasis Drug Icotrokinra
ZACKS· 2025-07-22 16:56
Core Viewpoint - Johnson & Johnson (JNJ) has submitted a new drug application (NDA) to the FDA for icotrokinra, an investigational oral peptide aimed at treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and above [1][9]. Group 1: Clinical Development and Efficacy - The NDA submission is based on data from four phase III studies, part of the ICONIC clinical development program, which evaluated icotrokinra as an IL-23 inhibitor for psoriasis and psoriatic arthritis [2]. - Icotrokinra met all primary and co-primary endpoints across the four pivotal studies, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing [3]. - The studies also showed icotrokinra's superiority over Bristol Myers' psoriasis drug, Sotyktu (deucravacitinib) [4][12]. Group 2: Market Position and Future Potential - JNJ's shares have increased by 13.7% this year, contrasting with a 2.1% decline in the industry [5]. - Management believes icotrokinra has the potential to transform the treatment landscape for plaque psoriasis and could establish itself as the new standard of care [6]. - Icotrokinra is designed to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases [7]. Group 3: Collaborative Development and Ongoing Studies - Icotrokinra is being developed in collaboration with Protagonist Therapeutics (PTGX), with JNJ holding exclusive worldwide rights for development beyond phase II studies [10]. - Positive results were reported from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in ulcerative colitis, meeting its primary endpoint [11]. - JNJ is conducting the phase III ICONIC-ASCEND study to compare icotrokinra with its own drug, Stelara (ustekinumab), aiming to provide a more convenient oral alternative [12].
Protagonist Therapeutics Inc (PTGX) 2025 Conference Transcript
2025-06-04 18:25
Summary of Protagonist Therapeutics Inc (PTGX) Conference Call Company Overview - **Company**: Protagonist Therapeutics Inc (PTGX) - **Event**: 2025 Jefferies Global Healthcare Conference - **Date**: June 04, 2025 Key Highlights from ASCO - Protagonist Therapeutics presented at the ASCO conference, where their drug Rasvotide was featured in a plenary session, selected from over 7,500 abstracts submitted [4][5] - The drug demonstrated significant efficacy in phase two studies, with p-values less than 0.0001, and showed consistent results across various subgroups [5][6] - Rasvotide is noted for improving the quality of life for patients with polycythemia vera (PV), marking it as a disease experience modifying drug [5][6] - The safety profile of Rasvotide was discussed, indicating it is well tolerated with no extraordinary safety concerns observed [7][9] Market Potential and Treatment Paradigm - The drug is positioned to address a significant unmet need in the treatment of PV, which affects patients over a long duration, averaging twenty years [6][11] - Current treatment paradigms often fail to maintain hematocrit levels below 45%, with over 75% of patients not achieving this goal [10][11] - Rasvotide is described as the first erythrocytosis-specific agent, differentiating it from existing treatments that indiscriminately lower red blood cells [11] Partnership and Regulatory Strategy - Protagonist is collaborating with Takeda, who will take over regulatory responsibilities for the NDA filing with the FDA [16][17] - The partnership includes an opt-out scenario for commercialization rights, with significant financial incentives for opting out, including a $400 million fee and higher milestone payments [18][19][20] - The peak market potential for Rasvotide is estimated between $1 billion to $2 billion, with Protagonist believing it can achieve the higher end of this range [19] Pipeline Developments - Protagonist is advancing its second lead program, ICO, which is in pivotal stages for psoriasis and ulcerative colitis [24][35] - The company is also developing an oral IL-17 agent, which is expected to enter phase one studies in Q4 of this year, and an oral hepcidin mimetic [43][47] - The obesity franchise is being developed with a focus on oral candidates, aiming to differentiate from existing injectable treatments [46] Financial Strategy - Protagonist is considering cash allocation strategies due to an anticipated influx of cash from upcoming milestones and potential approvals [57][59] - The company is exploring share buybacks as a tax-efficient method to return value to shareholders [59] Conclusion - Protagonist Therapeutics is positioned for significant growth with its innovative drug Rasvotide, a strong partnership with Takeda, and a promising pipeline of oral therapies. The company is strategically planning for future financial stability and shareholder value enhancement.
J&J(JNJ) - 2025 FY - Earnings Call Transcript
2025-05-28 14:00
Financial Data and Key Metrics Changes - The overall growth in the first quarter was 4.1%, with the pharmaceutical group growing by 4.2% and the med tech group by 4% [10] - The company has delivered consistent results, meeting or exceeding analyst expectations in earnings for 28 consecutive quarters over the past seven years [9] - The company has committed to a growth target of 5% to 7% from 2025 to 2030, with confidence in achieving this based on current results [11] Business Line Data and Key Metrics Changes - The pharmaceutical group showed a growth of 4.2% despite facing headwinds from biosimilars for its major product, Stellara [10] - The med tech group also reported a growth of 4%, indicating stability across both segments [10] - The company has invested $50 billion in M&A and R&D over the last two years, with an additional $55 billion planned for R&D manufacturing and technology in the U.S. over the next four years [11] Market Data and Key Metrics Changes - The company is optimistic about the biopharmaceutical and medical technology industries, citing significant medical innovation opportunities [5][22] - The U.S. market is seen as a key area for growth, with the administration's support for American businesses and manufacturing jobs [6] Company Strategy and Development Direction - Johnson & Johnson emphasizes its unique position as a healthcare company that spans the entire patient journey, with unmatched breadth in capabilities [7] - The company is focused on maintaining leadership in cardiac ablation and investing in new technologies to enhance its med tech offerings [56] - The strategy includes moving into higher growth markets, particularly in cardiovascular and robotics [85] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the industry despite macro uncertainties, highlighting a combination of headwinds and tailwinds [5][22] - The company is actively engaging with the administration to ensure continued innovation while making medicines affordable [23] - Management believes there are significant disconnects between market expectations and the company's potential, particularly in new product launches [12][14] Other Important Information - The company has a strong track record of dividend increases for 63 consecutive years, reflecting its financial stability [9] - The company is committed to improving gross margins and has various efficiency programs in place [51][54] Q&A Session Summary Question: How does the company view the current macro environment and its impact? - Management expressed optimism about the biopharmaceutical and medical technology industries, noting the potential for innovation despite uncertainties [22] Question: What is the company's strategy regarding drug pricing reforms? - Management highlighted the need for dialogue with the administration to balance innovation and affordability in medicines [24][30] Question: Can you provide an update on the talc litigation? - The company is back in the tort system and is confident in its position, having won 16 out of 17 cases related to ovarian cancer [37][38] Question: What are the expectations for financial performance in 2025? - The company is guiding for organic sales growth of 2% to 3% and EPS growth of 5% to 7%, with optimism about pharmaceutical product performance [43] Question: How does the company plan to address competitive pressures in the med tech space? - Management emphasized a commitment to innovation in cardiac ablation and plans to enhance its product offerings in electrophysiology [56][65]
J&J Oral Psoriasis Drug Meets Primary Goal in Late-Stage Study
ZACKS· 2025-05-12 13:15
Core Insights - Johnson & Johnson (J&J) announced positive results from the phase III ICONIC-TOTAL study for its investigational oral peptide, icotrokinra, aimed at treating plaque psoriasis in patients with moderate severity affecting sensitive areas [1][7]. Study Results - The study met its primary endpoint, with 57% of patients treated with icotrokinra achieving significant skin clearance compared to only 6% in the placebo group, as measured by the Investigator's Global Assessment (IGA) [2]. - In specific subgroups, 66% of patients with scalp psoriasis achieved clear or almost clear skin with icotrokinra versus 11% in the placebo group; 77% of patients with genital psoriasis achieved significant clearance compared to 21% in the placebo group; and 42% of patients in the hand/foot subgroup achieved clearance compared to 26% in the placebo group [4]. Stock Performance - Year to date, J&J's shares have increased nearly 7%, contrasting with a 6% decline in the industry [5]. Development and Collaboration - Icotrokinra is being developed in collaboration with Protagonist Therapeutics, with J&J holding exclusive worldwide rights for development beyond phase II studies [7]. - The ICONIC-TOTAL study is part of a broader late-stage ICONIC clinical program evaluating icotrokinra for psoriasis and psoriatic arthritis [8]. Additional Studies and Comparisons - J&J and Protagonist have reported positive results from two other phase III studies, ICONIC-ADVANCE 1 and 2, which demonstrated icotrokinra's superiority over Bristol Myers' psoriasis drug, Sotyktu [9]. - A phase III ICONIC-ASCEND study has been initiated to compare icotrokinra with J&J's own drug Stelara, aiming to provide a more convenient treatment option [10]. Market Potential - J&J believes icotrokinra has the potential to achieve peak non-risk-adjusted operational sales of $5 billion, with ongoing exploration of its use in inflammatory bowel disease [11].