Latest news with #Johnson&Johnson
Hamilton Spectator
7 hours ago
- Business
- Hamilton Spectator
Ipsen announces changes to its Executive Committee
PARIS, FRANCE, 23 July 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty care biopharmaceutical company, today announced the following changes to its Executive Committee: Mari, Andreas and Caroline will report to Ipsen's Chief Executive Officer, David Loew, beginning September 1, 2025. After 4 years successfully leading the commercial operations for the International Region at Ipsen, Mari Scheiffele will now lead all medicines in Oncology and Rare Disease at Ipsen. In the new role, Mari will focus on driving product development and pipeline innovation for new medicines and lead globally, brands and life cycle management. Mari succeeds Bartek Bednarz who will now lead the newly created Asia, Pacific & China region at Ipsen. Andreas Gerber joins Ipsen from Johnson & Johnson where he most recently served as Worldwide Vice-president and Head of the Oncology Franchise. In his new role as Head of International, Andreas will lead Ipsen's operations in all geographies excluding North America. Andreas's extensive business acumen and commercial operations experience will support driving growth in Ipsen's three therapeutic areas: Oncology, Rare Disease and Neuroscience across the International region. Andreas succeeds Mari Scheiffele. Finally, Caroline Sitbon has been promoted to the role of Ipsen's General Counsel. Caroline joined the company from GSK in 2024 as Senior Vice President, Legal Affairs. In her new role, Caroline will lead legal and business ethics and will also serve as the Board of Directors' General Secretary. Caroline succeeds François Garnier who will be retiring after a very successful career, including his tenure as Ipsen's General Counsel and General Secretary to the Board of Directors. 'These three appointments bring additional highly qualified global leaders to our executive leadership team and I'm delighted that they represent a combination of internal promotions and new leaders that have joined Ipsen,' said David Loew, Chief Executive Officer. 'After personally working with both Mari and Caroline throughout their tenure at Ipsen, I have been impressed by their leadership, business insights and innovative mindsets. Each of these leaders, in their respective fields, have strongly contributed and partnered with Executive Leadership Team members to the ongoing transformation that we have been successfully driving at Ipsen. I am also very pleased to welcome Andreas to Ipsen. Over the last few years, I have observed his accomplishments and am convinced that his leadership and capacity to inspire our teams to execute and deliver on our strategy will be instrumental in our continuous growth trajectory in those respective markets. These additions also now represent a gender-balanced Executive Committee at Ipsen. I would also like to warmly thank François Garnier who had a long and distinguished career at Ipsen, making a big impact on the development of our company.' Mari Scheiffele said, 'I am honored to step into the role of Chief Product Officer at such an exciting time for our company. I am committed to driving innovation, fostering a culture of excellence, and continuing to work with our teams to deliver impact for our customers and patients.' Andreas Gerber said, 'I am thrilled to join Ipsen to lead the International Region and to work, together, with a world-class team to make a real impact on patients' everyday lives. I am looking forward to driving our innovative medicines across the portfolio to create access and adoption for patients and customers worldwide and to realize the full potential of our transformative therapies.' Caroline Sitbon added, 'It is an honor to take the General Counsel and General Secretary role and be part of this dynamic and fast-growing organization committed to advancing science for patients and consumers. I am very excited to have the opportunity to lead a highly qualified team that ensures our commitment to remain unwavering in compliance and integrity'. ABOUT IPSEN We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit . IPSEN CONTACTS Investors Khalid Deojee +33 6 66 01 95 26 Media Sally Bain +1 857 32 00 517 Anne Liontas +33 6 69 09 12 96 Disclaimers and/or Forward-Looking Statements The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on Attachment
Business Upturn
7 hours ago
- Business
- Business Upturn
Ipsen announces changes to its Executive Committee
PARIS, FRANCE, 23 July 2025 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty care biopharmaceutical company, today announced the following changes to its Executive Committee: Mari Scheiffele is appointed to EVP, Chief Product Officer is appointed to Andreas Gerber is appointed to EVP, Head of International is appointed to Caroline Sitbon is appointed to EVP, General Counsel Mari, Andreas and Caroline will report to Ipsen's Chief Executive Officer, David Loew, beginning September 1, 2025. After 4 years successfully leading the commercial operations for the International Region at Ipsen, Mari Scheiffele will now lead all medicines in Oncology and Rare Disease at Ipsen. In the new role, Mari will focus on driving product development and pipeline innovation for new medicines and lead globally, brands and life cycle management. Mari succeeds Bartek Bednarz who will now lead the newly created Asia, Pacific & China region at Ipsen. Andreas Gerber joins Ipsen from Johnson & Johnson where he most recently served as Worldwide Vice-president and Head of the Oncology Franchise. In his new role as Head of International, Andreas will lead Ipsen's operations in all geographies excluding North America. Andreas's extensive business acumen and commercial operations experience will support driving growth in Ipsen's three therapeutic areas: Oncology, Rare Disease and Neuroscience across the International region. Andreas succeeds Mari Scheiffele. Finally, Caroline Sitbon has been promoted to the role of Ipsen's General Counsel. Caroline joined the company from GSK in 2024 as Senior Vice President, Legal Affairs. In her new role, Caroline will lead legal and business ethics and will also serve as the Board of Directors' General Secretary. Caroline succeeds François Garnier who will be retiring after a very successful career, including his tenure as Ipsen's General Counsel and General Secretary to the Board of Directors. 'These three appointments bring additional highly qualified global leaders to our executive leadership team and I'm delighted that they represent a combination of internal promotions and new leaders that have joined Ipsen,' said David Loew, Chief Executive Officer. 'After personally working with both Mari and Caroline throughout their tenure at Ipsen, I have been impressed by their leadership, business insights and innovative mindsets. Each of these leaders, in their respective fields, have strongly contributed and partnered with Executive Leadership Team members to the ongoing transformation that we have been successfully driving at Ipsen. I am also very pleased to welcome Andreas to Ipsen. Over the last few years, I have observed his accomplishments and am convinced that his leadership and capacity to inspire our teams to execute and deliver on our strategy will be instrumental in our continuous growth trajectory in those respective markets. These additions also now represent a gender-balanced Executive Committee at Ipsen. I would also like to warmly thank François Garnier who had a long and distinguished career at Ipsen, making a big impact on the development of our company.' Mari Scheiffele said, 'I am honored to step into the role of Chief Product Officer at such an exciting time for our company. I am committed to driving innovation, fostering a culture of excellence, and continuing to work with our teams to deliver impact for our customers and patients.' Andreas Gerber said, 'I am thrilled to join Ipsen to lead the International Region and to work, together, with a world-class team to make a real impact on patients' everyday lives. I am looking forward to driving our innovative medicines across the portfolio to create access and adoption for patients and customers worldwide and to realize the full potential of our transformative therapies.' Caroline Sitbon added, 'It is an honor to take the General Counsel and General Secretary role and be part of this dynamic and fast-growing organization committed to advancing science for patients and consumers. I am very excited to have the opportunity to lead a highly qualified team that ensures our commitment to remain unwavering in compliance and integrity'. ABOUT IPSEN We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit . IPSEN CONTACTS Investors Khalid Deojee [email protected] +33 6 66 01 95 26 Media Sally Bain [email protected] +1 857 32 00 517 Anne Liontas [email protected] +33 6 69 09 12 96 Disclaimers and/or Forward-Looking Statements The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on Attachment Ipsen PR_ELT Changes_23072025 Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Daily News Egypt
20 hours ago
- Health
- Daily News Egypt
Egypt's EDA discusses Johnson & Johnson's plans to expand investment in local pharmaceutical sector
Chairperson of the Egyptian Drug Authority (EDA), Ali Ghamrawy, met with a delegation from Johnson & Johnson to strengthen collaboration with one of the world's leading pharmaceutical companies. The meeting focused on fostering joint efforts in training, supporting pharmaceutical innovation, and facilitating access to advanced medicines—all in line with Egypt's strategy to enhance its healthcare sector and achieve the goals of Egypt Vision 2030. Key discussion points included cooperation in training programmes aimed at building the capacity of healthcare professionals, particularly in the field of health economics and its critical role in informed decision-making. The talks also covered mechanisms to ensure the timely and consistent availability of Johnson & Johnson's pharmaceutical innovations, aligned with national efforts to modernise healthcare and introduce cutting-edge medicines that advance public health in Egypt. During the meeting, Ghamrawy emphasised that the EDA attaches great importance to partnerships with leading international companies to help transfer expertise and technology. He added that this approach facilitates the registration and availability of modern medicines, supporting the state's plans to enhance the healthcare sector and achieve pharmaceutical self-sufficiency. Ghamrawy also underlined the Authority's commitment to operating according to the latest international standards to meet patient needs and bolster the competitiveness of Egypt's pharmaceutical market. He pointed out that Egypt offers significant potential to attract foreign direct investment, thanks to recent regulatory and institutional reforms that have positioned the country as one of the region's most promising pharmaceutical markets. For its part, the Johnson & Johnson delegation confirmed that this collaboration will help bring innovative pharmaceutical products to the Egyptian market, further strengthening Egypt's role as a regional hub for pharmaceutical manufacturing and exports. They also reaffirmed the company's commitment to making the latest medicines from Janssen—its pharmaceutical arm—available to Egyptian patients. The delegation expressed pride in its partnership with the EDA, which they described as a supportive environment for bringing the latest global pharmaceutical innovations to Egypt. The Johnson & Johnson delegation included Ahmed El-Houfi, CEO and Chairperson for Egypt, Jordan, Libya, Sudan, and Ethiopia; Hatem Dawood, Director of Market Access and Government Affairs; Sara Sedky, Scientific Office Manager; and Hossam El-Badry, Head of Import and Distribution.
Yahoo
a day ago
- Business
- Yahoo
Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill SPRING HOUSE, Pa., July 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.1,2,3 The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2c. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.4,5,6,7,8 "The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine. "Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease." Data submitted to the FDA as part of the NDA include: Results from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of Investigator's Global Assessment (IGA)d score of 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI)e 90 compared to placebo at Week 16.4 A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated pediatric patients 12 years of age and older treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.5 Data from the Phase 3 ICONIC-TOTAL study, presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.6 Results from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile met co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.7,8 Comprehensive results are being prepared for presentation at a future medical meeting. Long-term data from the ICONIC development program, including at least 52-weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting. Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCENDf study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.9 Editor's notes: a. ICONIC-LEAD is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque PsO, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients. b. ICONIC-TOTAL is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) with at least moderate severity affecting special areas (e.g., scalp, genital and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. c. ICONIC- ADVANCE 1 & 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque PsO with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.10 e. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness.11 PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.11 f. ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.9 About the ICONIC Clinical Development Program The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and adolescent individuals with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.12 ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.13 ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.14 Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.15,16 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.17,18 About Plaque Psoriasis Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.19 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.20 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.20 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.21 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.22 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.22,23 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,1 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.2,3 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.24 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.25 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.26,27,28 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, including ICONIC-ASCEND; the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis; and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.2 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.3 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.4 Bissonnette, R et al. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results Through Week 24 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-LEAD Trial. Late-breaking research presentation (Abstract #66708) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.5 Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025.6 Gooderham, M.J. et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23–receptor. Presented at the 2025 Society for Investigative Dermatology (Abstract #LB1142). May 2025.7 Data on file.8 Data on file.9 A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. Accessed July 2025.10 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/ Accessed July 2025.11 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: Accessed July 2025.12 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: Accessed July 2025.13 A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. Accessed July 2025.14 A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. Accessed July 2025.15 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. Accessed July 2025.16 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Accessed July 2025.17 A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. National Psoriasis Foundation. About Psoriasis. Available at: Accessed July 2025.20 National Psoriasis Foundation. Psoriasis Statistics. Available at: Accessed July 2025.21 National Psoriasis Foundation. Plaque Psoriasis. Available at: Accessed July 2025.22 National Psoriasis Foundation. Life with Psoriasis. Available at: Accessed July 2025.23 National Psoriasis Foundation. High Impact Sites. Available at: Accessed July 2025.24 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.25 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: Accessed July 2025.26 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: Accessed July 2025.27 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: Accessed July 2025.28 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: Accessed July 2025. Media contact: Meg Farina mfarina@ Investor contact: Lauren Johnson investor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson Sign in to access your portfolio
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Johnson & Johnson Stock (JNJ) Bulls Target Breakout Despite Looming Patent Cliff
Johnson & Johnson (JNJ) stock is gaining momentum this week following last week's impressive second-quarter 2025 earnings report. While many large pharmaceutical firms are grappling with 'patent cliffs'—the loss of exclusivity for blockbuster drugs—Johnson & Johnson is defying the trend thanks to its well-balanced portfolio of pharmaceuticals and medical devices. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. What truly stood out wasn't just the strong quarterly performance but also management's upgraded outlook for the full year. The company raised its revenue forecast by $2 billion and bumped up its adjusted EPS guidance by $0.25, signaling confidence in its ability to navigate the looming STELARA patent expiration. With this shift, I believe the stock is poised to break out of its five-year stagnation, reinforcing my Bullish stance. Q2 2025 Performance Hits Top Gear A deeper look at Johnson & Johnson's Q2 earnings reveals solid growth, with global sales reaching $23.7 billion—up 5.8% year-over-year—and net earnings climbing 18.2% to $5.5 billion. According to TipRanks data, the company clearly fits the definition of a 'cash cow,' having generated $6.2 billion in free cash flow during the quarter. While it carries a net debt of $32 billion (with $19 billion in cash and $51 billion in total debt), that burden is offset by its strong cash flow, underscoring the company's fundamentally sound financial position. Johnson & Johnson Looks Beyond STELARA Although STELARA's quarterly sales dropped 42.7% year-over-year to $1.65 billion, Johnson & Johnson more than made up for it with strong performance across other areas of its pharmaceutical portfolio. The standout gains came from its Oncology and Neuroscience segments. In Oncology, therapies like DARZALEX and CARVYKTI drove notable growth, with CARVYKTI—a cutting-edge CAR T-cell treatment—more than doubling its sales year-over-year to $439 million in the high-potential multiple myeloma market. On the Neuroscience front, CAPLYTA generated an impressive $211 million in sales, exceeding expectations. Johnson & Johnson acquired the drug through its $14.6 billion purchase of Intra-Cellular Therapies in April this year. As an FDA-approved treatment for bipolar depression and schizophrenia, CAPLYTA stands out as a differentiated atypical antipsychotic. With potential supplemental approvals on the horizon—for schizophrenia relapse prevention and adjunctive use in major depressive disorder—its total addressable market could expand significantly. MedTech Serves as Supplemental Revenue Stream Johnson & Johnson's medical devices division continues to show steady momentum, with global sales rising 6.1% year-over-year to $8.5 billion, according to TipRanks data. The standout performer was Cardiovascular surgery, which saw 22% growth—largely fueled by strong demand for the company's electrophysiology products and the Impella heart pump. Although the MedTech segment isn't as high-margin as the Innovative Medicines division, it plays a vital role in diversifying the company's revenue streams. Medical devices carry different risk profiles compared to pharmaceuticals, and in that sense, Johnson & Johnson benefits from having its bets spread across distinct sectors. Mitigating the Impact of Trump's Tariffs The company's progress occurs amid a macroeconomic environment that affects every business. However, Johnson & Johnson appears more resilient than others. It slashed its estimate for the impact of tariffs in 2025 from $400 million to around $200 million, primarily due to supply chain optimization. In the long run, Johnson & Johnson has committed to a $55 billion investment over the next three years to increase its U.S. manufacturing capacity and has declared its intention to manufacture all U.S.-prescribed medicines in the U.S. to mitigate future disruptions from trade wars and tariffs. Potential Risks and Headwinds on JNJ's Radar That said, it's essential to acknowledge the risks. Johnson & Johnson continues to face ongoing litigation related to its talc-based products. While it has already paid several billion dollars in settlements, additional liabilities could still arise. On the macroeconomic front, cost pressures are weighing on profitability, as evident in the MedTech segment, where margins declined from 25.7% to 22.2%. Competition remains intense across both business units, with major players like Medtronic (MDT), Abbott (ABT), and Pfizer (PFE) posing constant challenges. Lastly, the company's ability to maintain momentum hinges on the continued success of its newer drugs, which must offset the revenue decline from STELARA's loss of exclusivity. Is JNJ a Good Stock to Buy Now? On Wall Street, JNJ carries a Moderate Buy consensus rating based on eight Buy, ten Hold, and zero Sell ratings in the past three months. JNJ's average stock price target of $176.35 implies an upside potential of ~8% over the next 12 months. Just last week, Goldman Sachs analyst Asad Haider reiterated a Buy rating on Johnson & Johnson, citing strong second-quarter results as a key driver of his optimism. Haider noted that the company's decision to raise its 2025 guidance signals confidence in its outlook, with expected growth in both operational and reported revenues. He pointed to the continued strength of the Innovative Medicines division—particularly with standout products like Tremfya, Carvykti, and Darzalex—as effectively countering headwinds from Stelara's biosimilar competition. According to Haider, this positive momentum in earnings and sales forecasts positions JNJ ahead of both peers and the broader market. JNJ Prepares for Bullish Upside Without STELARA Johnson & Johnson is managing the STELARA patent cliff with notable poise. Strength in its Neuroscience and Oncology portfolios is helping to offset the declines in its legacy Immunology segment. At the same time, its dependable MedTech division continues to provide a stable foundation. Looking ahead, the company's ambitions are bold. It aims for $50 billion in annual oncology sales by 2030, driven by established therapies like CARVYKTI and promising pipeline candidates, such as TAR-200, for bladder cancer. While risks remain, many appear already priced into the stock. With a P/E ratio of 17.4—representing a 34% discount to the healthcare sector median —JNJ looks attractively valued. A successful transition beyond STELARA could lift a huge weight off its shoulders and trigger a meaningful price breakout. Add in a solid 3.07% dividend yield, and there's a compelling case to be made: Johnson & Johnson offers a lot of value at a very reasonable price.
