Galapagos NV Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to GLPG5101 for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 06 2025
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Should l Buy GLPG?
Source: Newsfilter
FDA Designation: Galapagos NV announced that the FDA has granted RMAT designation to its CAR-T product candidate GLPG5101 for treating relapsed/refractory mantle cell lymphoma, based on promising clinical data from the ATALANTA-1 study showing high response rates and manageable safety profiles.
Clinical Development Goals: The RMAT designation allows for closer collaboration with the FDA, facilitating accelerated development and review processes, while Galapagos plans to present updated data from the ongoing study at future medical conferences.
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Analyst Views on GLPG
Wall Street analysts forecast GLPG stock price to fall
4 Analyst Rating
1 Buy
1 Hold
2 Sell
Hold
Current: 33.430
Low
22.00
Averages
30.50
High
40.00
Current: 33.430
Low
22.00
Averages
30.50
High
40.00
About GLPG
Galapagos NV is a Belgium-based clinical-stage biotechnology company. The Company is engaged in the discovery and development of small molecule medicines with modes of action. Its pipeline comprises Phase 3, 2, 1, pre-clinical studies and discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications. The Company focuses on developing a portfolio of clinical-stage therapies for the enhancement of existing treatment paradigms. It develops transformational medicines in areas of high unmet need by combining internal with external science with the goal to add years of life and improve of life of patients across the globe. It discovers which proteins that are involved in causing diseases such as, rheumatoid, arthritis, inflammatory bowel disease and fibrosis. The Company acquired CellPoint and AboundBio in order to develop a cell therapy, which is a potential transformative treatment of different types of cancer.
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.
Bank of America Exceeds 5% Voting Rights in Galapagos
- Ownership Threshold Surpassed: Under Belgian transparency legislation, Bank of America crossed the 5% threshold of voting rights in Galapagos on February 9, 2026, reaching a total of 5.34%, indicating a strong commitment to the company.
- Voting Rights Breakdown: As of February 11, 2026, Bank of America and its affiliates held 104,522 voting rights and 3,415,894 equivalent financial instruments, enhancing their control over Galapagos and potentially influencing future corporate decisions.
- Transparency Notification: The notification from Bank of America, issued on February 11, 2026, reflects the changes in their shareholding, complying with Belgian legal requirements and providing clarity on their equity structure to the market.
- Market Implications: Bank of America's increased stake may heighten market interest in Galapagos, potentially driving stock price volatility and influencing other investors' decisions, reflecting growing confidence in the company's prospects.
See More
Vistra Corp Acquires Cogentrix Energy for Approximately $4.7 Billion
- Acquisition Announcement: Vistra Corp has announced the acquisition of Cogentrix Energy for approximately $4.7 billion, which will significantly enhance its competitive position in the energy market and expand its renewable energy portfolio.
- Market Reaction: Following the acquisition news, Vistra's stock rose by 4.13%, reflecting investor optimism regarding the company's future growth potential and further solidifying its position in the energy sector.
- Strategic Implications: This acquisition will not only increase Vistra's asset base but also enhance operational efficiency and market share through the integration of Cogentrix's resources and technologies, driving long-term profitability.
- Industry Outlook: Against the backdrop of global energy transition, Vistra's acquisition strategy indicates a commitment to sustainability, which is expected to attract more investor interest in its clean energy initiatives.
See More
Microchip Technology Raises Q3 FY2026 Sales Guidance to $1.185 Billion
- Sales Guidance Upgrade: Microchip Technology Inc expects third-quarter fiscal 2026 net sales of approximately $1.185 billion, exceeding its prior guidance range of $1.109 billion to $1.149 billion, indicating strong growth potential amid robust market demand.
- Positive Stock Reaction: In after-hours trading, Microchip's shares rose 3.2% to $69.20, reflecting investor optimism regarding the company's improved performance, which may further enhance market interest in its stock.
- Enhanced Market Competitiveness: With the sales guidance upgrade, Microchip solidifies its competitive position in the semiconductor industry, particularly in rapidly evolving technology sectors, attracting more investor attention.
- Upcoming Earnings Report: The company is set to release its earnings report after market close, with analysts expecting earnings of $1.04 per share and revenue of $761.13 million, providing investors with an opportunity to further assess the company's financial health.
See More
Galapagos GLPG3667 Achieves Significant Clinical Benefit in Dermatomyositis Study
- Clinical Trial Success: GLPG3667 demonstrated a statistically significant improvement in the Total Improvement Score (TIS) at a 150mg dose in the dermatomyositis study, achieving a p-value of 0.0848, which positions the drug as a promising new treatment option.
- Favorable Safety Profile: Throughout the 24-week treatment period, GLPG3667 exhibited a safety and tolerability profile consistent with previous studies, enhancing its competitive edge in the market.
- Strategic Evaluation: Galapagos is exploring all strategic alternatives, including resuming partnership discussions to accelerate the development of GLPG3667 in dermatomyositis and other autoimmune diseases, indicating the company's commitment to this drug.
- Future Outlook: The company plans to present data at an upcoming medical conference, further advancing the clinical development of GLPG3667 to meet the urgent market demand for effective treatments.
See More
Galapagos GLPG3667 Achieves Significant Clinical Benefit in Dermatomyositis Study
- Clinical Trial Success: GLPG3667 achieved a statistically significant improvement in the Total Improvement Score (TIS) in the GALARISSO study for dermatomyositis at a 150mg dose (p=0.0848), establishing its potential as a new treatment option.
- Favorable Safety Profile: Throughout the 24-week treatment period, GLPG3667 demonstrated a safety and tolerability profile consistent with previous studies, which may enhance its competitive positioning in the market.
- Strategic Evaluation: Galapagos is exploring all strategic alternatives, including resuming partnership discussions to accelerate the development of GLPG3667 in dermatomyositis and other severe autoimmune diseases, indicating the company's commitment to this drug.
- Future Outlook: The company plans to present data at an upcoming medical conference, aiming to further analyze the long-term effects of GLPG3667, potentially providing more treatment options for patients.
See More
Galapagos Achieves Key Objective in Phase 3 Study for Rare Autoimmune Disease Treatment
Phase 3 Study Results: Galapagos NV's selective TYK2 inhibitor, GLPG3667, successfully met its primary endpoint in a phase 3-enabling study for dermatomyositis, showing significant clinical benefits compared to placebo.
Lupus Study Outcome: A second phase 3-enabling study of GLPG3667 for lupus did not meet its primary endpoint, prompting the company to explore strategic options for further development.
Future Plans: The company plans to resume partnering discussions to accelerate the development of GLPG3667 for dermatomyositis following the positive results from the GALARISSO study.
Market Reaction: Following the announcement, Galapagos shares experienced a decline of approximately 3.6% in after-hours trading.
See More
Bank of America Exceeds 5% Voting Rights in Galapagos
- Ownership Threshold Surpassed: Under Belgian transparency legislation, Bank of America crossed the 5% threshold of voting rights in Galapagos on February 9, 2026, reaching a total of 5.34%, indicating a strong commitment to the company.
- Voting Rights Breakdown: As of February 11, 2026, Bank of America and its affiliates held 104,522 voting rights and 3,415,894 equivalent financial instruments, enhancing their control over Galapagos and potentially influencing future corporate decisions.
- Transparency Notification: The notification from Bank of America, issued on February 11, 2026, reflects the changes in their shareholding, complying with Belgian legal requirements and providing clarity on their equity structure to the market.
- Market Implications: Bank of America's increased stake may heighten market interest in Galapagos, potentially driving stock price volatility and influencing other investors' decisions, reflecting growing confidence in the company's prospects.
See More
Vistra Corp Acquires Cogentrix Energy for Approximately $4.7 Billion
- Acquisition Announcement: Vistra Corp has announced the acquisition of Cogentrix Energy for approximately $4.7 billion, which will significantly enhance its competitive position in the energy market and expand its renewable energy portfolio.
- Market Reaction: Following the acquisition news, Vistra's stock rose by 4.13%, reflecting investor optimism regarding the company's future growth potential and further solidifying its position in the energy sector.
- Strategic Implications: This acquisition will not only increase Vistra's asset base but also enhance operational efficiency and market share through the integration of Cogentrix's resources and technologies, driving long-term profitability.
- Industry Outlook: Against the backdrop of global energy transition, Vistra's acquisition strategy indicates a commitment to sustainability, which is expected to attract more investor interest in its clean energy initiatives.
See More
Microchip Technology Raises Q3 FY2026 Sales Guidance to $1.185 Billion
- Sales Guidance Upgrade: Microchip Technology Inc expects third-quarter fiscal 2026 net sales of approximately $1.185 billion, exceeding its prior guidance range of $1.109 billion to $1.149 billion, indicating strong growth potential amid robust market demand.
- Positive Stock Reaction: In after-hours trading, Microchip's shares rose 3.2% to $69.20, reflecting investor optimism regarding the company's improved performance, which may further enhance market interest in its stock.
- Enhanced Market Competitiveness: With the sales guidance upgrade, Microchip solidifies its competitive position in the semiconductor industry, particularly in rapidly evolving technology sectors, attracting more investor attention.
- Upcoming Earnings Report: The company is set to release its earnings report after market close, with analysts expecting earnings of $1.04 per share and revenue of $761.13 million, providing investors with an opportunity to further assess the company's financial health.
See More
Galapagos GLPG3667 Achieves Significant Clinical Benefit in Dermatomyositis Study
- Clinical Trial Success: GLPG3667 demonstrated a statistically significant improvement in the Total Improvement Score (TIS) at a 150mg dose in the dermatomyositis study, achieving a p-value of 0.0848, which positions the drug as a promising new treatment option.
- Favorable Safety Profile: Throughout the 24-week treatment period, GLPG3667 exhibited a safety and tolerability profile consistent with previous studies, enhancing its competitive edge in the market.
- Strategic Evaluation: Galapagos is exploring all strategic alternatives, including resuming partnership discussions to accelerate the development of GLPG3667 in dermatomyositis and other autoimmune diseases, indicating the company's commitment to this drug.
- Future Outlook: The company plans to present data at an upcoming medical conference, further advancing the clinical development of GLPG3667 to meet the urgent market demand for effective treatments.
See More
Galapagos GLPG3667 Achieves Significant Clinical Benefit in Dermatomyositis Study
- Clinical Trial Success: GLPG3667 achieved a statistically significant improvement in the Total Improvement Score (TIS) in the GALARISSO study for dermatomyositis at a 150mg dose (p=0.0848), establishing its potential as a new treatment option.
- Favorable Safety Profile: Throughout the 24-week treatment period, GLPG3667 demonstrated a safety and tolerability profile consistent with previous studies, which may enhance its competitive positioning in the market.
- Strategic Evaluation: Galapagos is exploring all strategic alternatives, including resuming partnership discussions to accelerate the development of GLPG3667 in dermatomyositis and other severe autoimmune diseases, indicating the company's commitment to this drug.
- Future Outlook: The company plans to present data at an upcoming medical conference, aiming to further analyze the long-term effects of GLPG3667, potentially providing more treatment options for patients.
See More
Galapagos Achieves Key Objective in Phase 3 Study for Rare Autoimmune Disease Treatment
Phase 3 Study Results: Galapagos NV's selective TYK2 inhibitor, GLPG3667, successfully met its primary endpoint in a phase 3-enabling study for dermatomyositis, showing significant clinical benefits compared to placebo.
Lupus Study Outcome: A second phase 3-enabling study of GLPG3667 for lupus did not meet its primary endpoint, prompting the company to explore strategic options for further development.
Future Plans: The company plans to resume partnering discussions to accelerate the development of GLPG3667 for dermatomyositis following the positive results from the GALARISSO study.
Market Reaction: Following the announcement, Galapagos shares experienced a decline of approximately 3.6% in after-hours trading.
See More
