Legend Biotech Corporation reports news on cell therapy development and commercialization, centered on CARVYKTI® (ciltacabtagene autoleucel), a CAR-T therapy for relapsed or refractory multiple myeloma developed and marketed with Johnson & Johnson. Company updates commonly cover CARVYKTI sales trends, treatment-site expansion, manufacturing capacity, clinical and real-world data from the CARTITUDE program, and label or evidence developments tied to multiple myeloma care.
Legend Biotech news also follows its broader cell therapy pipeline, including allogeneic and in vivo CAR-T programs such as LUCAR-G39D in B-cell non-Hodgkin lymphoma. Recurring announcements include quarterly financial results, scientific-conference presentations, research and manufacturing priorities, advisory input, and corporate governance updates.
Legend Biotech (NASDAQ: LEGN), a GenScript subsidiary, has received approval from China's NMPA for ciltacabtagene autoleucel (cilta-cel), a CAR-T therapy for relapsed or refractory multiple myeloma. This breakthrough treatment is approved for adult patients who have undergone at least three prior therapies. The approval is based on the CARTIFAN-1 clinical trial, which showed impressive results:
- 87.9% overall response rate
- 79.3% complete or stringent complete response
- 32.56 months median duration of response
- 30.13 months median progression-free survival
This milestone reinforces GenScript's commitment to innovation in cell therapy and strengthens its position in the biotech industry.
Legend Biotech (NASDAQ: LEGN), a global leader in cell therapy, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will take place in New York, NY on September 4, 2024. CEO Ying Huang, Ph.D., will engage in a fireside chat at 2:35 p.m. ET.
Investors and interested parties can access the live webcast through the Investor Relations section of Legend's website. A replay of the webcast will be available approximately 48 hours after the event. This conference participation highlights Legend Biotech's commitment to engaging with the investment community and sharing insights into its cell therapy advancements.
Legend Biotech (NASDAQ: LEGN) reported its Q2 2024 results, highlighting CARVYKTI®'s net trade sales of $186 million. The company received MHRA and Health Canada approvals for CARVYKTI® in earlier treatment lines for multiple myeloma. Positive overall survival results were demonstrated in the CARTITUDE-4 study. Legend Biotech's cash position stood at $1.3 billion as of June 30, 2024, providing runway into 2026.
Financial highlights include license revenue of $90.8 million, up from $15.1 million in Q2 2023, and collaboration revenue of $93.3 million, increased from $58.2 million. The company reported a net loss of $18.2 million, significantly reduced from $199.1 million in the same period last year. Research and development expenses rose to $112.6 million, reflecting ongoing investment in cilta-cel and solid tumor programs.
Legend Biotech (NASDAQ: LEGN), a global leader in cell therapy, announced the appointment of Peter Salovey, Ph.D., President Emeritus of Yale University, to its Board of Directors, effective August 9, 2024. Dr. Salovey brings extensive experience in medical research and public health, having led significant developments at Yale, including expanding faculty and launching new schools. His expertise in health communication and human emotion research, including founding the Yale Center for Emotional Intelligence, is expected to bring valuable insights to Legend Biotech.
Legend Biotech (NASDAQ: LEGN), a global cell therapy leader, has released preliminary, unaudited financial results for the six months ended June 30, 2024. The company anticipates an adjusted net loss between $94.7 million and $109.7 million for this period. This estimate excludes equity-settled share-based compensation expenses (net of tax) of $38.4-$44.5 million and exchange gains of $57.7-$66.8 million. Legend Biotech's actual net loss is expected to be $75.4-$87.4 million. The company emphasizes that these are preliminary estimates subject to change, with final results to be reported on August 9, 2024. Legend Biotech uses non-IFRS financial measures, including adjusted net loss, to comply with Hong Kong Stock Exchange listing rules.
Legend Biotech (NASDAQ: LEGN) will host an investor conference call on August 9, 2024, at 8:00 am ET to discuss its Q2 2024 results. The company's senior leaders will review the quarterly performance during the webcast. Investors can join the live audio webcast via a provided weblink, and a replay will be accessible in the Investor Relations section of Legend Biotech's website approximately two hours after the call concludes.
Legend Biotech (NASDAQ: LEGN) announced positive overall survival results from the Phase 3 CARTITUDE-4 trial, evaluating CARVYKTI® in relapsed and lenalidomide-refractory multiple myeloma. The trial showed statistically significant and clinically meaningful improvement in overall survival compared to PVd and DPd regimens.
The safety profile was consistent with previous data, and no new safety signals were identified. The results will be shared with regulatory agencies for potential updates. CARVYKTI® had already gained FDA approval on April 5, 2024.
However, the study reported a higher percentage of early deaths in the CARVYKTI® arm, primarily due to adverse events and infections. Other risks include cytokine release syndrome, neurologic toxicities, and secondary malignancies.
Legend Biotech shared promising data on CARVYKTI® (ciltacabtagene autoleucel) for treating multiple myeloma at ASCO and EHA 2024. The CARTITUDE-2 Cohort D study showed a 94% overall response rate and 80% MRD negativity with one-time CARVYKTI® infusion. CARTITUDE-4 analysis revealed CARVYKTI® improved progression-free survival (PFS) vs standard therapy in high-risk patients. The efficacy of CARVYKTI® was consistent across different cytogenetic abnormalities. However, safety concerns including CRS, ICANS, and infections were noted.
These findings support CARVYKTI®'s potential as a new standard of care for high-risk multiple myeloma patients refractory to lenalidomide. Further Phase 3 studies are underway to evaluate CARVYKTI® in earlier treatment settings.
Legend Biotech (NASDAQ: LEGN), a global leader in cell therapy, announced that CEO Ying Huang, Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference. This event will take place in New York, NY, on June 6, 2024, at 10:30 a.m. ET. Investors and other interested parties can view the live webcast through the Investor Relations section of Legend's website. A replay will be available approximately 48 hours after the event.
Legend Biotech (NASDAQ: LEGN) will present new data on its CAR-T cell therapy, CARVYKTI®, for multiple myeloma at the 2024 ASCO and EHA events.
Significant upcoming presentations include:
- Phase 2 CARTITUDE-2 study data will be presented at ASCO and EHA.
- Phase 3 CARTITUDE-4 study data regarding high-risk multiple myeloma will also be showcased.
Key studies analyze CARVYKTI®'s effectiveness in patients with different risk profiles and those who had suboptimal responses to previous treatments.
Despite positive advancements, warnings about severe side effects such as cytokine release syndrome, neurologic toxicities, and other serious adverse events were noted.