FDA Eases Access To Life-Saving Gene Therapies For Blood Cancers
FDA Removes REMS for CAR T Cell Therapies: The FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for approved BCMA- and CD19-directed autologous CAR T cell immunotherapies, which are used to treat blood cancers, allowing for easier access to these potentially curative treatments.
Impact on Treatment Accessibility: This decision is expected to reduce regulatory burdens on healthcare providers and increase patient access to CAR T therapies, with implications for future therapies in both oncology and autoimmune diseases.
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Arcellx's Novel D-Domain Binder Accepted for Presentation at 2026 Tandem Meetings
- Preclinical Study Results: Arcellx's D-Domain binder showed no tonic signaling or off-target activity in preclinical assessments, supporting its unique target-specific binding profile and potentially positioning anito-cel as a best-in-class safety option, enhancing its competitiveness in multiple myeloma treatment.
- Dual VHH Binder Risks: Specific off-target activity against Claudin-9 was observed with the dual VHH binder compared to cilta-cel, indicating a potential increase in off-tumor toxicities, thereby highlighting the safety advantages of the D-Domain binder.
- Cell Activation and Cytokine Release: CAR T cell activation and cytokine release were observed with dual VHH and scFv binders in the absence of BCMA antigen, while the D-Domain did not exhibit tonic signaling, further validating its safety and specificity.
- Conference Presentation Details: The findings will be presented on February 5, 2026, at the Tandem Meetings in Salt Lake City, showcasing the D-Domain binder's potential for anti-tumor activity while minimizing tonic signaling and off-target reactivity risks.
Director David Lubner Sells 6,000 Shares of Arcellx Stock
- Transaction Overview: On January 20, 2026, Director David Charles Lubner executed the sale of 6,000 shares of Arcellx common stock for approximately $450,000, indicating a significant reduction in his ownership stake.
- Ownership Stake Reduction: This transaction reduced Lubner's direct holdings by 21.69%, from 27,659 shares to 21,659 shares, while his 59,405 options remained unchanged, suggesting a potential shift in confidence regarding the company's future.
- Market Performance Insight: As of January 20, 2026, Arcellx's stock price stood at $68.31 with a market capitalization of $3.95 billion; despite a 15% decline in stock value in 2025, the company has sufficient funding to operate through 2028, indicating some financial stability.
- Clinical Development and Investor Outlook: Arcellx has made significant progress with its multiple myeloma treatment, advancing to phase two development, which could become a major revenue driver if successful, although the company still faces challenges with negative operating income.
FDA Draft Guidance Boosts Arcellx (ACLX) and Legend Biotech (LEGN) Stock Prices
- FDA Guidance Impact: The U.S. FDA's draft guidance allows minimal residual disease and complete response as endpoints for accelerated approval in multiple myeloma treatments, leading to a stock price increase for Arcellx (ACLX) and Legend Biotech (LEGN), reflecting market optimism for new therapies.
- Collaborative Prospects: Legend Biotech's partnership with Johnson & Johnson (JNJ) on the Carvykti cell therapy has already incorporated MRD negativity as an endpoint in the CARTITUDE-6 trial, which analysts view as a positive development for its market performance.
- Market Competition Analysis: Analysts highlight that Arcellx's anito-cel therapy is also expected to enter the market based on MRD negativity, enhancing its competitiveness in the second to fourth-line treatment settings and increasing investment appeal in this sector.
- Investment Rating Changes: Jefferies maintains an Outperform rating on Legend Biotech with a target price of $66, noting that while the stock trades at a significant discount, the FDA guidance provides a clear positive signal for its future growth.
Stocks to Consider Buying in 2026: Insights from Our Roundtable Experts, Including DoorDash and LVMH
Stock Picks Overview: The second installment of the 2026 Barron’s Roundtable features 30 stock picks from five investment experts, highlighting both well-known companies and lesser-known options.
Familiar Names Included: Among the stock picks are recognizable brands such as Home Depot, Starbucks, and Nike, indicating a mix of established and emerging investment opportunities.
Biodegradable Innovation: The article hints at a British company that has recently acquired a manufacturer of biodegradable sneaker midsoles, showcasing a trend towards sustainable products in the footwear industry.
Investment Insights: The Roundtable serves as a platform for sharing diverse investment strategies and insights, appealing to both seasoned investors and those looking to explore new market trends.
Wells Fargo Upgrades Arcellx to Overweight Due to Potential of Multiple Myeloma CAR-T Asset
Wells Fargo Coverage: Wells Fargo has initiated coverage of Arcellx (ACLX) with an overweight rating, highlighting its CAR-T therapy, anito-cel, as a significant future treatment for multiple myeloma, setting a price target of $100.
Market Potential: Analyst Yanan Zhu anticipates that anito-cel could dominate the BCMA CAR-T market in fourth-line multiple myeloma due to its efficacy and safety, with peak sales projections of $1.6 billion in the fourth line and $3.8 billion if approved for second-line treatment.
Approval Timeline: Zhu expects anito-cel to gain approval in the second line by 2028, potentially earlier, which would enhance its market presence and sales.
Competitive Landscape: Despite strong data for Johnson & Johnson's combination therapy for multiple myeloma, Zhu notes that a significant portion of patients are ineligible for this treatment, indicating a continued need for alternative therapies like anito-cel.
Deutsche Bank Raises Woodward Price Target to $400, Reiterates Buy
- Price Target Increase: Deutsche Bank raised Woodward's price target from $300 to $400, reflecting strong confidence in the aerospace company, with expectations that its aftermarket potential will drive long-term growth.
- Market Leadership: Analysts believe Woodward's market leadership in aerospace positions it as one of the best long-term organic compounding stories, further solidifying investor confidence in its future performance.
- Optimistic Industry Outlook: As the aerospace sector recovers, Woodward's performance is expected to improve significantly, with analysts' optimistic projections likely attracting more investor attention to the company.
- Enhanced Investor Confidence: Deutsche Bank's reiteration of the buy rating not only reflects confidence in Woodward but may also encourage other institutions to follow suit, potentially driving the stock price higher.
Arcellx's Novel D-Domain Binder Accepted for Presentation at 2026 Tandem Meetings
- Preclinical Study Results: Arcellx's D-Domain binder showed no tonic signaling or off-target activity in preclinical assessments, supporting its unique target-specific binding profile and potentially positioning anito-cel as a best-in-class safety option, enhancing its competitiveness in multiple myeloma treatment.
- Dual VHH Binder Risks: Specific off-target activity against Claudin-9 was observed with the dual VHH binder compared to cilta-cel, indicating a potential increase in off-tumor toxicities, thereby highlighting the safety advantages of the D-Domain binder.
- Cell Activation and Cytokine Release: CAR T cell activation and cytokine release were observed with dual VHH and scFv binders in the absence of BCMA antigen, while the D-Domain did not exhibit tonic signaling, further validating its safety and specificity.
- Conference Presentation Details: The findings will be presented on February 5, 2026, at the Tandem Meetings in Salt Lake City, showcasing the D-Domain binder's potential for anti-tumor activity while minimizing tonic signaling and off-target reactivity risks.
Director David Lubner Sells 6,000 Shares of Arcellx Stock
- Transaction Overview: On January 20, 2026, Director David Charles Lubner executed the sale of 6,000 shares of Arcellx common stock for approximately $450,000, indicating a significant reduction in his ownership stake.
- Ownership Stake Reduction: This transaction reduced Lubner's direct holdings by 21.69%, from 27,659 shares to 21,659 shares, while his 59,405 options remained unchanged, suggesting a potential shift in confidence regarding the company's future.
- Market Performance Insight: As of January 20, 2026, Arcellx's stock price stood at $68.31 with a market capitalization of $3.95 billion; despite a 15% decline in stock value in 2025, the company has sufficient funding to operate through 2028, indicating some financial stability.
- Clinical Development and Investor Outlook: Arcellx has made significant progress with its multiple myeloma treatment, advancing to phase two development, which could become a major revenue driver if successful, although the company still faces challenges with negative operating income.
FDA Draft Guidance Boosts Arcellx (ACLX) and Legend Biotech (LEGN) Stock Prices
- FDA Guidance Impact: The U.S. FDA's draft guidance allows minimal residual disease and complete response as endpoints for accelerated approval in multiple myeloma treatments, leading to a stock price increase for Arcellx (ACLX) and Legend Biotech (LEGN), reflecting market optimism for new therapies.
- Collaborative Prospects: Legend Biotech's partnership with Johnson & Johnson (JNJ) on the Carvykti cell therapy has already incorporated MRD negativity as an endpoint in the CARTITUDE-6 trial, which analysts view as a positive development for its market performance.
- Market Competition Analysis: Analysts highlight that Arcellx's anito-cel therapy is also expected to enter the market based on MRD negativity, enhancing its competitiveness in the second to fourth-line treatment settings and increasing investment appeal in this sector.
- Investment Rating Changes: Jefferies maintains an Outperform rating on Legend Biotech with a target price of $66, noting that while the stock trades at a significant discount, the FDA guidance provides a clear positive signal for its future growth.
Stocks to Consider Buying in 2026: Insights from Our Roundtable Experts, Including DoorDash and LVMH
Stock Picks Overview: The second installment of the 2026 Barron’s Roundtable features 30 stock picks from five investment experts, highlighting both well-known companies and lesser-known options.
Familiar Names Included: Among the stock picks are recognizable brands such as Home Depot, Starbucks, and Nike, indicating a mix of established and emerging investment opportunities.
Biodegradable Innovation: The article hints at a British company that has recently acquired a manufacturer of biodegradable sneaker midsoles, showcasing a trend towards sustainable products in the footwear industry.
Investment Insights: The Roundtable serves as a platform for sharing diverse investment strategies and insights, appealing to both seasoned investors and those looking to explore new market trends.
Wells Fargo Upgrades Arcellx to Overweight Due to Potential of Multiple Myeloma CAR-T Asset
Wells Fargo Coverage: Wells Fargo has initiated coverage of Arcellx (ACLX) with an overweight rating, highlighting its CAR-T therapy, anito-cel, as a significant future treatment for multiple myeloma, setting a price target of $100.
Market Potential: Analyst Yanan Zhu anticipates that anito-cel could dominate the BCMA CAR-T market in fourth-line multiple myeloma due to its efficacy and safety, with peak sales projections of $1.6 billion in the fourth line and $3.8 billion if approved for second-line treatment.
Approval Timeline: Zhu expects anito-cel to gain approval in the second line by 2028, potentially earlier, which would enhance its market presence and sales.
Competitive Landscape: Despite strong data for Johnson & Johnson's combination therapy for multiple myeloma, Zhu notes that a significant portion of patients are ineligible for this treatment, indicating a continued need for alternative therapies like anito-cel.
Deutsche Bank Raises Woodward Price Target to $400, Reiterates Buy
- Price Target Increase: Deutsche Bank raised Woodward's price target from $300 to $400, reflecting strong confidence in the aerospace company, with expectations that its aftermarket potential will drive long-term growth.
- Market Leadership: Analysts believe Woodward's market leadership in aerospace positions it as one of the best long-term organic compounding stories, further solidifying investor confidence in its future performance.
- Optimistic Industry Outlook: As the aerospace sector recovers, Woodward's performance is expected to improve significantly, with analysts' optimistic projections likely attracting more investor attention to the company.
- Enhanced Investor Confidence: Deutsche Bank's reiteration of the buy rating not only reflects confidence in Woodward but may also encourage other institutions to follow suit, potentially driving the stock price higher.
