J&J Stops Alzheimer's Study as Drug Proves Ineffective in Slowing Disease Progression
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 25 2025
0mins
Should l Buy JNJ?
Source: Benzinga
Johnson & Johnson's Study Results: The Phase 2b AuTonomy study of posdinemab for early Alzheimer's disease did not achieve statistical significance in slowing clinical decline, leading to its discontinuation.
FDA Designation and Potential: Posdinemab received Fast Track designation from the FDA, showing potential to target phosphorylated tau in Alzheimer's patients, but its recent failure raises concerns for future Alzheimer's drug developments.
Novo Nordisk's Trial Findings: Novo Nordisk's phase 3 trials for semaglutide in early-stage Alzheimer's disease also failed to show superiority over placebo in reducing disease progression.
Market Reaction: Following the news, Johnson & Johnson's stock rose to a new 52-week high, trading at $206.99, reflecting investor sentiment despite the study setback.
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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: 243.330
Low
190.00
Averages
218.50
High
240.00
Current: 243.330
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.
Johnson & Johnson Receives FDA Breakthrough Therapy Designation
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- Clinical Trial Support: This designation is supported by data from the Phase 1b/2 OrigAMI-4 study, where Rybrevant Faspro demonstrated rapid and durable responses in heavily pretreated patients, enhancing its competitive position in the market.
- Multiple Indications: Rybrevant Faspro is already approved for various indications in the treatment of non-small cell lung cancer and is being evaluated for use in other solid tumors, including colorectal cancer, showcasing its broad therapeutic potential.
- Stock Performance: Although Johnson & Johnson shares closed at $243.33 on Tuesday, down 0.05%, the Breakthrough Therapy Designation may boost market expectations for its future performance and enhance investor confidence.
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- Massive Investment: Johnson & Johnson has announced an investment of over $1 billion in a next-generation cell therapy manufacturing facility in Montgomery County, Pennsylvania, which is expected to create over 500 biomanufacturing jobs and 4,000 construction jobs, significantly boosting the local economy.
- Significant Economic Impact: This investment is part of the company's broader $55 billion commitment to U.S. investments by 2029, aimed at enhancing its manufacturing capacity in the U.S. to meet the needs of patients, thereby increasing the company's competitiveness in the global market.
- Innovative Manufacturing Capability: The new facility will utilize cutting-edge cell therapy technologies to support Johnson & Johnson's portfolio of transformational medicines for cancer, immune-mediated, and neurological diseases, further solidifying its leadership in the life sciences sector.
- Local Government Support: The Governor of Pennsylvania highlighted that the state's leadership in life sciences and advanced manufacturing has attracted companies like Johnson & Johnson to increase their investments, demonstrating effective execution of the state's economic development plan and strategic investments in key industries.
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- Investment Announcement: Johnson & Johnson has unveiled plans to invest over $1 billion in a cell therapy manufacturing facility in Pennsylvania, further enhancing its operational footprint in the state and demonstrating a long-term commitment to U.S. manufacturing.
- Job Creation: The new facility is expected to generate over 500 biomanufacturing jobs and more than 4,000 construction jobs, significantly boosting local employment and economic growth, reflecting J&J's positive impact on the community.
- Expansion Strategy: This investment is part of J&J's broader strategy to allocate $55 billion in the U.S. by 2029, aimed at expanding its presence in manufacturing, R&D, and technology, thereby solidifying its market leadership.
- Legacy of Innovation: CEO Joaquin Duato remarked that with 140 years of innovation in American healthcare, this investment will continue to advance J&J's legacy in Pennsylvania, underscoring the company's ongoing commitment to innovation.
See More
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- Contract Extension: The collaboration agreement signed by Johnson & Johnson in January 2025 has been extended to mid-2026 under the same economic terms, including a fixed monthly management fee, driven by strong engagement and satisfaction metrics, reflecting ongoing confidence in the program's performance.
- Market Model Development: Trellus Health CEO Marla Dubinsky stated that the company is establishing a scalable go-to-market model for pharmaceuticals, focusing on disciplined execution, recurring revenue growth, and expansion in immunology and inflammation, showcasing a positive outlook for future developments.
- Financial Outlook: Trellus Health expects fiscal 2025 revenue to be approximately $545,000 and has reduced its monthly cash burn to around $400,000, demonstrating improved financial management and confidence in future growth prospects.
See More
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- Regulatory Streamlining: Legislation passed by Congress in November simplifies the regulatory process for transitioning prescription drugs to OTC status, including full, conditional, and partial switch pathways, which is expected to accelerate drug availability and enhance patient convenience in medication access.
- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.
See More
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- FDA Breakthrough Therapy Designation: Johnson & Johnson's RYBREVANTFASPRO™ has received Breakthrough Therapy Designation from the FDA for treating recurrent or metastatic head and neck squamous cell carcinoma, marking a significant advancement in cancer treatment that is expected to substantially improve patient survival rates.
- Clinical Trial Support: This designation is supported by data from the OrigAMI-4 study, which demonstrated rapid and durable clinical responses in heavily pretreated patients, further validating its potential in a patient population with limited treatment options.
- Multi-Targeted Treatment Strategy: RYBREVANTFASPRO™ aims to improve treatment outcomes for head and neck cancer patients by simultaneously targeting both EGFR and MET pathways, which is expected to alter disease biology and reduce treatment resistance, thereby enhancing patients' quality of life.
- Ongoing Research Plans: Johnson & Johnson is conducting the Phase 3 OrigAMI-5 trial to evaluate the efficacy of RYBREVANTFASPRO™ in combination with other agents, further advancing its application in head and neck cancer and potentially providing new treatment options for patients.
See More
Johnson & Johnson Receives FDA Breakthrough Therapy Designation
- Breakthrough Therapy Designation: Johnson & Johnson's subcutaneous Rybrevant Faspro has received Breakthrough Therapy Designation from the FDA for adult patients with advanced head and neck squamous cell carcinoma, marking a significant advancement in cancer treatment.
- Clinical Trial Support: This designation is supported by data from the Phase 1b/2 OrigAMI-4 study, where Rybrevant Faspro demonstrated rapid and durable responses in heavily pretreated patients, enhancing its competitive position in the market.
- Multiple Indications: Rybrevant Faspro is already approved for various indications in the treatment of non-small cell lung cancer and is being evaluated for use in other solid tumors, including colorectal cancer, showcasing its broad therapeutic potential.
- Stock Performance: Although Johnson & Johnson shares closed at $243.33 on Tuesday, down 0.05%, the Breakthrough Therapy Designation may boost market expectations for its future performance and enhance investor confidence.
See More
Johnson & Johnson Invests Over $1 Billion in Pennsylvania
- Massive Investment: Johnson & Johnson has announced an investment of over $1 billion in a next-generation cell therapy manufacturing facility in Montgomery County, Pennsylvania, which is expected to create over 500 biomanufacturing jobs and 4,000 construction jobs, significantly boosting the local economy.
- Significant Economic Impact: This investment is part of the company's broader $55 billion commitment to U.S. investments by 2029, aimed at enhancing its manufacturing capacity in the U.S. to meet the needs of patients, thereby increasing the company's competitiveness in the global market.
- Innovative Manufacturing Capability: The new facility will utilize cutting-edge cell therapy technologies to support Johnson & Johnson's portfolio of transformational medicines for cancer, immune-mediated, and neurological diseases, further solidifying its leadership in the life sciences sector.
- Local Government Support: The Governor of Pennsylvania highlighted that the state's leadership in life sciences and advanced manufacturing has attracted companies like Johnson & Johnson to increase their investments, demonstrating effective execution of the state's economic development plan and strategic investments in key industries.
See More
Johnson & Johnson to Invest Over $1B in Pennsylvania Cell Therapy Facility
- Investment Announcement: Johnson & Johnson has unveiled plans to invest over $1 billion in a cell therapy manufacturing facility in Pennsylvania, further enhancing its operational footprint in the state and demonstrating a long-term commitment to U.S. manufacturing.
- Job Creation: The new facility is expected to generate over 500 biomanufacturing jobs and more than 4,000 construction jobs, significantly boosting local employment and economic growth, reflecting J&J's positive impact on the community.
- Expansion Strategy: This investment is part of J&J's broader strategy to allocate $55 billion in the U.S. by 2029, aimed at expanding its presence in manufacturing, R&D, and technology, thereby solidifying its market leadership.
- Legacy of Innovation: CEO Joaquin Duato remarked that with 140 years of innovation in American healthcare, this investment will continue to advance J&J's legacy in Pennsylvania, underscoring the company's ongoing commitment to innovation.
See More
FDA Grants Breakthrough Therapy Designation for Rybrevant
- Breakthrough Therapy Designation: The FDA has granted Breakthrough Therapy Designation for Rybrevant (amivantamab and hyaluronidase-lpuj) as a monotherapy for adults with advanced head and neck squamous cell carcinoma, applicable to patients with recurrent or metastatic disease after progression on platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, indicating strong recognition and market potential for the new therapy.
- Contract Extension: The collaboration agreement signed by Johnson & Johnson in January 2025 has been extended to mid-2026 under the same economic terms, including a fixed monthly management fee, driven by strong engagement and satisfaction metrics, reflecting ongoing confidence in the program's performance.
- Market Model Development: Trellus Health CEO Marla Dubinsky stated that the company is establishing a scalable go-to-market model for pharmaceuticals, focusing on disciplined execution, recurring revenue growth, and expansion in immunology and inflammation, showcasing a positive outlook for future developments.
- Financial Outlook: Trellus Health expects fiscal 2025 revenue to be approximately $545,000 and has reduced its monthly cash burn to around $400,000, demonstrating improved financial management and confidence in future growth prospects.
See More
FDA Pushes for Prescription Drugs to Become Over-the-Counter
- Policy Advocacy: FDA Commissioner Marty Makary stated in Washington that the agency plans to push for more prescription drugs to become over-the-counter (OTC) this year, aiming to improve drug accessibility and reduce healthcare costs, which could allow patients to obtain basic safe medications without a doctor's visit.
- Regulatory Streamlining: Legislation passed by Congress in November simplifies the regulatory process for transitioning prescription drugs to OTC status, including full, conditional, and partial switch pathways, which is expected to accelerate drug availability and enhance patient convenience in medication access.
- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.
See More
Johnson & Johnson Receives FDA Breakthrough Therapy Designation
- FDA Breakthrough Therapy Designation: Johnson & Johnson's RYBREVANTFASPRO™ has received Breakthrough Therapy Designation from the FDA for treating recurrent or metastatic head and neck squamous cell carcinoma, marking a significant advancement in cancer treatment that is expected to substantially improve patient survival rates.
- Clinical Trial Support: This designation is supported by data from the OrigAMI-4 study, which demonstrated rapid and durable clinical responses in heavily pretreated patients, further validating its potential in a patient population with limited treatment options.
- Multi-Targeted Treatment Strategy: RYBREVANTFASPRO™ aims to improve treatment outcomes for head and neck cancer patients by simultaneously targeting both EGFR and MET pathways, which is expected to alter disease biology and reduce treatment resistance, thereby enhancing patients' quality of life.
- Ongoing Research Plans: Johnson & Johnson is conducting the Phase 3 OrigAMI-5 trial to evaluate the efficacy of RYBREVANTFASPRO™ in combination with other agents, further advancing its application in head and neck cancer and potentially providing new treatment options for patients.
See More
