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Legend Biotech’s CARVYKTI therapy for myeloma gets positive CHMP opinion



© Reuters.

SOMERSET, N.J. – Legend Biotech Corporation (NASDAQ: LEGN), a cell therapy company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed the expansion of the CARVYKTI® label. This recommendation allows for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy. The European Commission will review the CHMP’s opinion for final approval.

The CHMP’s positive opinion is based on data from the CARTITUDE-4 study, which is the first Phase 3 study to assess CARVYKTI® against other treatments in patients with relapsed and lenalidomide-refractory multiple myeloma. The study demonstrated a significant clinical benefit for patients who relapsed early in their disease treatment. CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy.

Currently, CARVYKTI® is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The therapy comes with a boxed warning for cytokine release syndrome, neurologic toxicities, and other potential side effects, and is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Legend Biotech has partnered with Janssen Biotech, Inc. for the development and commercialization of CARVYKTI®. The therapy has previously received approval from the U.S. Food and Drug Administration (FDA) in February 2022, conditional marketing authorization from the European Commission in May 2022, and approval from Japan’s Ministry of Health, Labour and Welfare in September 2022.

This development represents a potential new treatment option for patients with multiple myeloma, a blood cancer that begins in the bone marrow. The disease is estimated to result in more than 35,000 diagnoses and over 12,000 deaths in the U.S. in 2024. The information in this article is based on a press release statement.

InvestingPro Insights

As Legend Biotech Corporation (NASDAQ: LEGN) awaits final approval from the European Commission for its CARVYKTI® label expansion, investors and industry observers are closely watching the company’s financial health and market performance. According to InvestingPro data, Legend Biotech boasts a market capitalization of $11.22 billion and has experienced a notable revenue growth of 120.27% over the last twelve months as of Q1 2023. This surge is further highlighted by an impressive quarterly revenue growth of 250.91% in Q1 2023, signaling strong market demand for its therapies.

Despite these strong growth indicators, the company’s financials reflect some challenges. Legend Biotech’s gross profit margin stands at -110.88%, indicating that it has been spending more on the costs of goods sold than it has been able to earn in revenue. This is further emphasized by an operating income margin of -192.77%, showcasing the expenses outweighing the operational earnings. Additionally, the company’s P/E ratio is currently negative at -21.01, reflecting the market’s anticipation of future earnings or a reflection of its growth potential.

InvestingPro Tips for Legend Biotech emphasize the company’s strong cash position, with more cash than debt on its balance sheet, and the fact that its liquid assets exceed short-term obligations, indicating a solid financial stance for immediate needs. However, analysts do not anticipate the company to be profitable this year, and it has not been profitable over the last twelve months. It’s important to note that the stock price often moves in the opposite direction of the market, which could be a consideration for investors seeking to diversify or hedge their portfolios.

For those interested in a deeper dive into Legend Biotech’s financials and market performance, InvestingPro offers additional insights. There are currently 9 more InvestingPro Tips available for LEGN at For readers looking to access these valuable insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

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