SOMERSET, N.J. - Legend Biotech Corporation (NASDAQ: LEGN), a global biotechnology company specializing in cell therapy, has received approval from the European Commission (EC) for its CARVYKTI® treatment for adult patients with relapsed and refractory multiple myeloma.
This approval, announced today, allows the use of CARVYKTI® in patients who have undergone at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and have shown disease progression on their last therapy while being refractory to lenalidomide.
The EC's decision is based on the findings from the CARTITUDE-4 study, which showed that CARVYKTI® significantly improved progression-free survival compared to standard treatment regimens in adults with relapsed and lenalidomide-refractory multiple myeloma.
The study compared CARVYKTI® to treatment regimens consisting of pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients who received one to three prior lines of therapy.
The Type-II variation application for CARVYKTI® was submitted by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., part of Johnson & Johnson, which collaborates with Legend Biotech for the development and commercialization of the therapy.
The EC's approval comes on the heels of the U.S. Food and Drug Administration's (FDA) approval on April 5th for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
CARVYKTI® has been associated with severe side effects, including cytokine release syndrome, neurologic toxicities, hematological malignancies, and increased early mortality in some cases. The treatment is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS Program due to these risks.
The approval of CARVYKTI® represents a significant advancement in the treatment options available to patients with multiple myeloma, providing a potential new therapy for those who have limited options after their first relapse. This article is based on a press release statement from Legend Biotech Corporation.
InvestingPro Insights
Following the European Commission's approval of CARVYKTI®, Legend Biotech Corporation (NASDAQ: LEGN) has shown potential in the biotechnology landscape with its innovative cell therapy treatments. While the clinical advancement is promising, it's essential to consider the company's financial health and market performance to understand its overall position.
InvestingPro data reveals Legend Biotech's market capitalization stands at 8.4 billion USD, reflecting the scale of the company within the biotech industry. Despite challenging market conditions, analysts have identified a silver lining, noting that Legend Biotech holds more cash than debt on its balance sheet, which could provide a buffer against financial uncertainties.
Moreover, the company's revenue has experienced substantial growth over the last twelve months as of Q4 2023, with an impressive increase of 143.7%. This growth trajectory is anticipated to continue, with analysts expecting sales growth in the current year.
Still, not all indicators are positive. The company's gross profit margin for the same period was notably low at -84.62%, and it has been flagged for weak gross profit margins. Moreover, Legend Biotech is currently trading near its 52-week low, and the stock has taken a significant hit over the last week, month, and six-month periods, with price total returns of -10.67%, -20.55%, and -30.58%, respectively.
For investors considering Legend Biotech as a potential addition to their portfolio, two InvestingPro Tips are particularly relevant: the stock's Relative Strength Index (RSI) suggests it is in oversold territory, which some may interpret as a buying opportunity, and analysts do not anticipate the company will be profitable this year, which could impact long-term investment decisions.
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