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FDA Approves Johnson & Johnson's Tremfya For Crohn's Disease
Benzinga· 2025-03-21 12:23
Core Insights - The FDA has approved Johnson & Johnson's Tremfya (guselkumab) as the first IL-23 inhibitor for adults with moderately to severely active Crohn's disease, offering both subcutaneous and intravenous induction options [1] - The approval is based on results from multiple Phase 3 trials involving over 1,300 patients who were either intolerant to or had failed conventional therapies [2] - Tremfya has now received its fourth indication in the U.S., following approvals for plaque psoriasis, psoriatic arthritis, and ulcerative colitis [4] Sales Performance - In 2024, Tremfya generated sales of $3.67 billion, reflecting a 17% year-over-year increase [5] Clinical Studies - The GRAVITI study demonstrated the efficacy of Tremfya SC induction and maintenance therapy compared to placebo [3] - Data from the GALAXI clinical program indicated that Tremfya outperformed Johnson & Johnson's Stelara in all pooled endoscopic endpoints [3]
U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
Prnewswire· 2025-03-20 22:12
Core Insights - TREMFYA® (guselkumab) has received FDA approval for the treatment of adults with moderately to severely active Crohn's disease, marking it as the first and only IL-23 inhibitor with both subcutaneous and intravenous induction options [2][3] - The approval builds on previous indications for TREMFYA® in moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis, highlighting Johnson & Johnson's commitment to addressing chronic immune-mediated diseases [3][8] - Clinical trials, including the GRAVITI and GALAXI studies, demonstrated TREMFYA®'s superiority over STELARA® in achieving clinical remission and endoscopic response, with significant efficacy results [2][6][7] Company Overview - Johnson & Johnson is a leader in healthcare innovation, focusing on developing treatments for chronic immune-mediated diseases, including inflammatory bowel disease [2][39] - The company maintains exclusive worldwide marketing rights to TREMFYA® and is committed to supporting patient access through programs like TREMFYA® withMe [2][10] Industry Context - Crohn's disease affects approximately three million Americans, and there is a significant need for effective treatment options as many patients continue to experience debilitating symptoms despite existing therapies [2][8] - The approval of TREMFYA® represents a significant advancement in the treatment landscape for Crohn's disease, providing a new option that allows for self-administration and flexibility in treatment regimens [2][3][6]
Johnson & Johnson's Golden Cross: Technical Momentum Meets Groundbreaking Lung Cancer Breakthrough
Benzinga· 2025-03-20 17:55
Core Viewpoint - Johnson & Johnson's stock has recently exhibited a bullish technical pattern known as a Golden Cross, indicating potential long-term upside, supported by a significant breakthrough in lung cancer treatment [1][4]. Technical Analysis - The stock price of Johnson & Johnson is currently at $162.37, with short-term moving averages showing mixed signals. The 8-day simple moving average is at $163.37 and the 20-day simple moving average is at $164.45, indicating slight selling pressure. However, the 50-day simple moving average at $156.24 and the 200-day simple moving average at $155.72 support a bullish trend [1]. - The Moving Average Convergence Divergence (MACD) indicator stands at 1.74, reinforcing the bullish outlook, while the Relative Strength Index (RSI) is at 52.33, indicating the stock is in neutral territory [2]. Breakthrough in Cancer Treatment - Johnson & Johnson announced a significant milestone in lung cancer treatment, with the Phase 3 MARIPOSA study showing that the combination therapy of RYBREVANT (amivantamab-vmjw) and LAZCLUZE (lazertinib) significantly improved survival rates for patients with advanced non-small cell lung cancer [2]. - The European Medicines Agency is considering approval for this breakthrough, which could serve as a long-term revenue driver for the company [3]. Investor Considerations - The Golden Cross pattern suggests a long-term bullish trend for Johnson & Johnson's stock, although short-term resistance levels may pose challenges. The combination of a promising cancer treatment and bullish technical signals provides both fundamental and technical reasons for investors to monitor the company closely [4].
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Prnewswire· 2025-03-20 12:00
Core Insights - Johnson & Johnson announced promising overall survival data from the Phase 3 MARIPOSA study, indicating that the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) may significantly improve survival rates compared to osimertinib for patients with EGFR-mutated non-small cell lung cancer (NSCLC) [1][6][9] - The company aims to redefine treatment expectations for patients with EGFR mutations, emphasizing the potential for longer survival and improved quality of life with the new treatment regimen [2][3] Company Developments - The Phase 3 MARIPOSA study results will be presented at the 2025 European Lung Cancer Congress, showcasing the efficacy of RYBREVANT® plus LAZCLUZE™ in first-line treatment for advanced NSCLC [1][6] - Additional studies, including the Phase 2 COCOON study, will present data on a dermatologic regimen aimed at enhancing patient experience during treatment [2][6] Industry Context - NSCLC accounts for 80 to 85 percent of all lung cancer cases, with EGFR mutations being a significant driver of the disease [13] - The five-year survival rate for advanced NSCLC patients with EGFR mutations treated with current therapies remains low, highlighting the need for innovative treatment options like RYBREVANT® and LAZCLUZE™ [13][30]
JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease
ZACKS· 2025-03-19 16:00
Johnson & Johnson (JNJ) announced that the FDA has granted a Fast Track designation ("FTD') to its investigational drug, nipocalimab, for treating adult patients with moderate-to-severe Sjögren's disease ("SjD"), a chronic autoimmune disease. Currently, there are no advanced therapies approved by the FDA for the given indication. The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which ...
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation
Prnewswire· 2025-03-18 12:03
Sjögren's disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments   The Company is actively enrolling patients in the Phase 3 DAFFODIL study   This marks the fourth nipocalimab FDA Fast Track designation SPRING HOUSE, Pa., March 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with mod ...
Resilient Investing: 3 Stocks Built to Weather Market Volatility
MarketBeat· 2025-03-17 12:46
Core Insights - The article emphasizes the importance of resilience investing in the face of inflation and potential recession, focusing on companies with strong financial health and diversified income streams [1] Johnson & Johnson - Johnson & Johnson (JNJ) is highlighted as a defensive investment within the stable healthcare sector, with a diversified business model that includes Innovative Medicine and MedTech [2] - JNJ's financial health is reinforced by its AAA credit rating, shared only with Microsoft among US companies [2] - The company reported a revenue of $88.821 billion in 2024, a 4.3% increase from the previous year, with adjusted net earnings of $24.242 billion [3] - JNJ's Innovative Medicine segment saw a 5.7% operational growth in 2024, while the MedTech segment achieved 6.2% operational growth [4] - The stock forecast for JNJ indicates a current price of $162.94 with a 12-month target of $171.33, reflecting a potential upside of 5.15% [3][4] Microsoft - Microsoft (MSFT) demonstrates resilience through its transition to a recurring revenue model, primarily via cloud services, allowing it to navigate economic challenges effectively [5] - The company reported total revenue of $69.6 billion in Q2 2025, a 12% year-over-year increase, with cloud revenue reaching $40.9 billion, up 21% [6] - Microsoft's AI business has surpassed an annual revenue run rate of $13 billion, showing a remarkable 175% year-over-year growth [6] - The stock forecast for MSFT shows a current price of $388.56 with a 12-month target of $510.43, indicating a potential upside of 31.36% [6][7] Waste Management - Waste Management (WM) is presented as a resilient company due to the essential nature of its services, providing stable revenue regardless of economic conditions [8] - The company reported revenue of $22.063 billion in 2024, an 8.0% increase from the previous year, with adjusted operating EBITDA of $6.563 billion [9] - WM is projected to see revenue growth of 16.4% and adjusted operating EBITDA growth of 15.0% in 2025 [9] - The stock forecast for WM indicates a current price of $225.06 with a 12-month target of $236.65, reflecting a potential upside of 5.15% [9][10] Resilience Investing - The article concludes that resilience investing is not limited to a single industry, but rather focuses on identifying companies with strong financials, diversified revenue streams, and adaptability to market changes [11]
An AI imaging firm says Johnson & Johnson stole its tech. Execs on both sides are expected to testify next week.
Business Insider· 2025-03-15 09:07
Core Points - Johnson & Johnson (J&J) entered a multibillion-dollar contract with ChemImage in 2019 to develop AI-powered surgical imaging technology [1][4] - ChemImage has filed a $1.5 billion breach of contract lawsuit against J&J, claiming the healthcare giant failed to uphold its commitments [2][3] - The trial will determine if J&J terminated the contract "with cause" or "without cause," impacting potential damages owed to ChemImage [5][6] Group 1: Contract Details - The contract included a $7 million upfront payment and outlined a potential total of $1.5 billion in royalties based on future milestones [4] - ChemImage alleges that J&J's decision to terminate the contract has harmed its business and technology development [3][4] Group 2: Legal Proceedings - The trial is presided over by US District Judge Jesse Furman, with ChemImage seeking $180 million in penalties and overdue payments [2] - J&J will argue that ChemImage failed to meet developmental milestones, justifying the contract termination [7] - ChemImage counters that delays were due to J&J's own technological issues and lack of engagement [8] Group 3: Witnesses - Nine current and former J&J executives, including key figures from the MedTech division, are expected to testify [10] - ChemImage will also call its former executives, including its ex-CEO, to support its claims [10]
Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis
Prnewswire· 2025-03-08 14:00
Standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift treatment paradigmNearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEADTopline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO These results pave the ...
JNJ Halts Development of Depression Drug Over Efficacy Concerns
ZACKS· 2025-03-07 18:45
Johnson & Johnson (JNJ) decided to discontinue the Phase 3 VENTURA development program, which is evaluating aticaprant as an adjunctive treatment for major depressive disorder (MDD).Though data from the VENTURA program did confirm that the J&J drug was safe and well-tolerated in study participants, the decision to stop developing it for MDD indication is due to ‘insufficient efficacy in the target patient population.’ However, the pharma giant still intends to explore aticaprant’s potential ‘in other areas ...