SOMERSET, N.J., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will host a conference call for investors at 8:00 am ET on Tuesday, March 10, 2026, to review fourth-quarter and full-year 2025 financial results. During the conference call and accompanying webcast, senior management will provide an overview of quarterly and full-year financial performance. Investors and other interested parties may access the live audio webcast via ...

Gilead to acquire cancer therapy developer Arcellx for up to $7.8 billion | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Logos of Gilead at the company's booth at the 8th China International Import Expo (CIIE) in Shanghai, China, November 6, 2025.REUTERS/Maxim Shemetov [Purchase Licensing Rights, opens new tab]- Companies[Arcellx Inc]Follow[Gilead Sciences Inc]FollowFeb 23 (Reuters) - Gilead Sciences will pay as much as $7.8 billi ...

Core Insights - Legend Biotech is presenting six poster presentations on CARVYKTI at the upcoming Tandem Meetings, showcasing its efficacy, safety, and real-world outcomes in treating multiple myeloma [1][4]. Group 1: CARVYKTI Efficacy and Safety - CARVYKTI has treated over 10,000 patients globally, generating substantial clinical and real-world evidence for its use in multiple myeloma treatment [2]. - The therapy demonstrates consistent and durable efficacy and safety, particularly when administered earlier in the treatment journey, leading to meaningful quality-adjusted survival gains [3][4]. - CARVYKTI is the first and only BCMA-targeted CAR-T cell therapy approved for patients with multiple myeloma who have undergone at least one prior line of therapy, and it is now available in 14 countries [4]. Group 2: Poster Presentations Overview - The six poster presentations will cover various aspects of CARVYKTI, including quality-adjusted survival analysis, management of neurologic events, and the impact of bridging therapy on treatment outcomes [5][6]. - Specific topics include the characterization of neurologic events, the relationship between bridging therapy response and safety outcomes, and long-term progression-free survival benefits [5][6]. Group 3: Industry Context - Multiple myeloma is an incurable blood cancer with an estimated 35,000 new diagnoses and over 12,000 deaths in the U.S. in 2024, highlighting the critical need for effective treatments like CARVYKTI [58]. - Legend Biotech is positioned as a leader in cell therapy, focusing on maximizing patient access and therapeutic potential of CARVYKTI while expanding its pipeline of innovative treatments [59].

Core Insights - Legend Biotech Corporation is positioned for transformative growth in 2026, aiming for profitability through the global adoption of its CAR-T therapy, CARVYKTI, which has treated over 10,000 patients [2][5][6] Group 1: Commercial Progress - CARVYKTI has solidified its leadership in multiple myeloma CAR-T cell therapy, achieving a milestone of over 10,000 patients treated [2][6] - The company expanded CARVYKTI's global footprint to over 279 sites across 14 markets in 2025, with plans for further globalization in 2026 [6] - The Raritan facility has been expanded, now being the largest cell therapy manufacturing facility in the U.S., capable of supporting treatment for up to 10,000 patients annually [5][6] Group 2: Clinical Advancements - Promising first-in-human results were presented for the allogeneic CAR-T candidate LUCAR-G39D, showing encouraging safety and efficacy in B-cell non-Hodgkin lymphoma [4] - New clinical data from the CARTITUDE-1 and CARTITUDE-4 trials demonstrated significant benefits of CARVYKTI, including a median progression-free survival (PFS) of 50.4 months for triple-class-exposed patients [6] - The company completed enrollment for the Phase 3 CARTITUDE-6 trial in newly diagnosed multiple myeloma patients who are transplant eligible [6] Group 3: Financial Outlook - The company anticipates achieving profitability in 2026, driven by continued revenue growth from CARVYKTI and operating margin expansion [5][11] - As of September 30, 2025, the company reported approximately $1.0 billion in cash and cash equivalents, providing a financial runway beyond 2026 [11] Group 4: Strategic Priorities - The strategic priorities for 2026 include maximizing CARVYKTI's market leadership and advancing cell therapy innovation [3][5] - The company is committed to leveraging its CAR-T development platform to explore new in vivo and allogeneic opportunities [2][3]

Company Overview - Legend Biotech (NASDAQ:LEGN) is a commercial-stage biopharmaceutical company focused on developing innovative therapies for serious diseases, including hematologic malignancies and solid tumors [5]. Stock Performance and Analyst Ratings - As of December 19, Legend Biotech's stock has a consensus rating that remains bullish, with 10 out of 11 analysts assigning Buy ratings and 1 analyst assigning a Hold rating. There are no Sell ratings for the stock [2]. - The stock has an estimated 1-year average price target of $68.20, indicating a potential upside of 211% from current trading levels [2]. - Cantor Fitzgerald analyst Eric Schmidt reaffirmed an overweight stance on the stock, assigning a Buy rating with a target price of $74, suggesting a 238% upside potential at the current trading range [3]. Product and Market Insights - Management views CAR-T cell therapy, specifically Carvykti, as a unique cure for myeloma, supported by long-term survival benefit data. The increasing demand for myeloma treatment is expected to drive production scaling [4]. - The management's positive outlook on CAR-T therapy and the anticipated growth in demand are seen as factors that outweigh potential competitive threats in the market, strengthening the investment case for Legend Biotech [4].

Core Insights - Imugene Ltd has received full support from the US FDA for its Phase 1B study data regarding its CAR-T cell therapy, azer-cel, validating the proposed dosing regimen, lymphodepletion schedule, and manufacturing process [1][2] - The FDA's feedback allows the company to proceed with its pivotal study design, confirming the efficacy, safety, and process standards of azer-cel [2][8] - The company reported an 82% overall response rate from its Phase 1B trial, indicating strong potential for the therapy [4][10] FDA Support and Study Progress - The FDA has not requested further data or dosing adjustments, which is considered a rare outcome at this stage of development [2][8] - The CEO emphasized that the FDA's affirmation provides a clear path for the pivotal study, as all aspects of the proposed plan have been approved [8][10] - Imugene is currently dosing its CAR-T naïve cohort, which has no approved CAR-T therapies, representing a rapid opportunity for data generation and regulatory engagement [3][9] Future Plans and Data Collection - The company is actively presenting azer-cel at the ASH conference and plans to continue collecting clinical data while preparing for pivotal manufacturing steps in the upcoming year [3][10] - The strategy includes gathering data in both DLBCL and the CAR-T naïve cohort, aiming for a fast-to-market approach [10]

Core Insights - Immix Biopharma's NXC-201 demonstrated a complete response (CR) rate of 75% in a Phase 2 trial for relapsed/refractory AL Amyloidosis, with potential to increase to 95% based on MRD negativity predictions [1][3][4] - The company plans to submit a Biologics License Application (BLA) for NXC-201 in 2026 following the final readout of the NEXICART-2 trial [1][2] Clinical Results - In the Phase 2 trial, 15 out of 20 patients achieved a complete response, indicating significant efficacy [1][3] - Prior to treatment, patients had a median of 4 prior lines of therapy, and all had organ involvement due to AL Amyloidosis [3] - Clinical improvements were observed in 70% of evaluable patients, with no neurotoxicity reported [3] Market Context - Current treatments for relapsed/refractory AL Amyloidosis yield a CR rate of 10% or lower, highlighting a significant unmet medical need [4] - The U.S. patient population for relapsed/refractory AL Amyloidosis is projected to grow by 12% annually, reaching approximately 38,500 patients by 2026 [9] - The AL Amyloidosis market is expected to grow from $3.6 billion in 2017 to $6 billion by 2025 [9] Company Overview - Immix Biopharma is focused on developing NXC-201, a BCMA-targeted CAR-T cell therapy, which has received RMAT and Orphan Drug Designation from the FDA [7][10] - The ongoing NEXICART-2 trial is designed to enroll 40 patients and is pivotal for the company's future regulatory submissions [6][10]

Summary of Caribou Biosciences FY Conference Call Company Overview - **Company**: Caribou Biosciences (NasdaqGS:CRBU) - **Focus**: Development of CAR-T therapies, specifically the Vispacel product for treating large cell B-cell lymphoma and the CB-011 program for myeloma Key Points on Vispacel Program - **Clinical Updates**: - Vispacel has been evaluated in the clinic for approximately four and a half years, showing promising results that resemble autologous CAR-T therapies [4][5] - After treating 84 patients, response rates and duration of response for Vispacel are nearly identical to autologous CAR-T, with a notable safety profile [5][6] - 75% of large cell B-cell lymphoma patients do not receive autologous CAR-T, indicating a significant market opportunity [5] - **Safety Profile**: - Vispacel demonstrated low rates of cytokine release syndrome, high-grade neurotoxicity, and severe infections, making it comparable to Lysosel, a better-tolerated product [6][7] - **Target Patient Population**: - Focus on patients ineligible for autologous CAR-T and auto transplants, including those facing geographical, insurance, and manufacturing challenges [7][19] - Plans for a pivotal trial involving approximately 250 patients randomized against immunochemotherapy, which lacks curative intent [7][9] - **Durability of Outcomes**: - Data indicates a plateau in durability of responses similar to autologous CAR-T, with low relapse rates compared to immunochemotherapy [8][9] - **Regulatory Strategy**: - Anticipated label for Vispacel will include auto CAR-T ineligible and auto transplant ineligible populations, with no significant barriers expected [19][20] - **Community Center Access**: - There is a strong desire from community centers to treat patients with Vispacel, as many patients refuse to travel to academic centers [25][27] Key Points on CB-011 Program - **Market Positioning**: - CB-011 is positioned against bispecific antibodies, with a focus on the myeloma patient population, where only about 10% currently receive autologous CAR-T [30] - Physicians express interest in an allogeneic CAR-T that matches or exceeds the efficacy of bispecifics, highlighting the treatment burden associated with bispecific therapies [30][31] - **Clinical Development**: - Expansion of the 450 million cell cohort to approximately 30 patients to better estimate overall response rates and MRD negativity [33][41] - The goal is to achieve median progression-free survival (PFS) rates comparable to bispecifics, targeting around 15 months [33] - **Competitive Landscape**: - Other allogeneic CAR-T products and in vivo CAR-T therapies are seen as less competitive due to their current stage of development and regulatory challenges [42][44] Additional Insights - **Manufacturing and Cost Efficiency**: - Vispacel can be manufactured and stockpiled, allowing for immediate availability upon patient eligibility confirmation, with significantly lower costs of goods sold (COGS) compared to autologous CAR-T [45][46] - **Patient Access Challenges**: - A significant portion of patients in the second-line setting are dual ineligible for both transplant and autologous CAR-T, indicating a meaningful market for Vispacel [27][29] This summary encapsulates the critical insights from the conference call, highlighting Caribou Biosciences' strategic focus on expanding access to CAR-T therapies through innovative product development and addressing patient needs in underserved populations.

Core Insights - Caribou Biosciences, Inc. is hosting a panel discussion on vispa-cel, an allogeneic anti-CD19 CAR-T cell therapy, aimed at expanding patient access for second-line large B cell lymphoma treatment [1][2] Company Overview - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on developing transformative therapies for patients with severe diseases [6] - The company is advancing vispacabtagene regedleucel (vispa-cel), which is the first allogeneic CAR-T cell therapy in clinical trials with a PD-1 knockout designed to enhance CAR-T cell activity [4] Clinical Trial Information - The ANTLER phase 1 clinical trial is evaluating vispa-cel in adult patients with relapsed or refractory B cell non-Hodgkin lymphoma, with 84 patients treated as of September 2, 2025 [5] - The trial has shown positive data indicating that vispa-cel's efficacy and durability are comparable to autologous CAR-T cell therapies [5] Event Details - The expert panel discussion will take place in-person at the Hyatt Regency Orlando on December 6, 2025, and will also be available virtually [2][3] - The event will be moderated by Caribou's Chief Medical Officer, Dr. Tina Albertson, and will feature insights from leading physicians regarding access challenges and patient needs [2]

Core Insights - Immix Biopharma has appointed Michael Grabow as Chief Commercial Officer to lead the U.S. launch and commercialization of NXC-201 for relapsed/refractory AL Amyloidosis, a rare blood disease with no current FDA-approved therapies [1][2] Company Overview - Immix Biopharma, Inc. is recognized as the global leader in relapsed/refractory AL Amyloidosis [6] - The company is focused on developing NXC-201, a CAR-T cell therapy designed to target and eliminate toxic light chains produced in AL Amyloidosis [5][7] Product Details - NXC-201 is a sterically-optimized BCMA-targeted CAR-T cell therapy that has received both Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD) from the FDA [5][7] - The therapy aims to address a significant unmet medical need in relapsed/refractory AL Amyloidosis, which is characterized by organ failure and high mortality rates [2][3] Market Insights - The AL Amyloidosis patient population in the U.S. is projected to grow at a rate of 12% annually, reaching approximately 37,270 patients by 2025 [3] - The amyloidosis market was valued at $3.6 billion in 2017 and is expected to grow to $6 billion by 2025 [4]