SOMERSET, N.J. - Legend Biotech Corporation (NASDAQ: LEGN), a biotech company specializing in cell therapy, announced today that its CAR-T cell therapy, CARVYKTI® (ciltacabtagene autoleucel), has demonstrated a statistically significant and clinically meaningful improvement in overall survival.
This finding comes from the second interim analysis of the CARTITUDE-4 study, which is a Phase 3 trial involving patients with relapsed and lenalidomide-refractory multiple myeloma.
The trial compared the efficacy and safety of CARVYKTI® against two other treatment regimens in adult patients who had previously undergone one to three lines of therapy. The safety outcomes were consistent with the known safety profile of CARVYKTI®, and no new safety concerns were identified.
CARVYKTI® received approval from the U.S. Food and Drug Administration (FDA) on April 5, 2024, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy line. It is the first and only BCMA-targeted CAR-T cell therapy approved by the FDA for this indication.
The latest results from the CARTITUDE-4 study will be presented at an upcoming medical meeting and submitted to regulatory agencies worldwide for potential label updates. The CARTITUDE-4 study is ongoing and involves participants who have received prior treatments including a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide.
This announcement is based on a press release statement from Legend Biotech Corporation.
In other recent news, Legend Biotech has been the focus of several analysts, with RBC Capital maintaining an Outperform rating and Piper Sandler reiterating an Overweight rating. These endorsements come amidst strong demand for Legend Biotech's Carvykti, which is expected to drive significant revenue growth. Piper Sandler projects Carvykti's revenues to reach $900 million this year, with a significant increase to $1.75 billion by 2025.
Truist Securities has also initiated coverage on Legend Biotech with a Buy rating, citing the potential of Carvykti. Meanwhile, Citi maintains a bullish stance, expecting a sales increase in the latter half of 2024 due to capacity expansion and upcoming product launches.
Legend Biotech is also progressing in its research and development, initiating IND-enabling studies for two allogeneic therapies. The company concluded the first quarter of 2024 with approximately $1.3 billion in cash reserves, expected to sustain the company until it reaches operating profit in 2026.
InvestingPro Insights
Legend Biotech Corporation (NASDAQ: LEGN) has recently made a significant stride in the biotech industry with its CAR-T cell therapy, CARVYKTI®, showing promising results in a Phase 3 trial. As investors digest this news, it's worth considering some key financial metrics and expert analysis from InvestingPro.
InvestingPro Data:
- Legend Biotech's market capitalization stands at $8.39 billion, reflecting the market's valuation of the company's potential in the competitive biotech landscape.
- The company's revenue has shown an impressive growth rate, with a 206.05% increase in the last twelve months as of Q1 2024.
- Despite this revenue growth, Legend Biotech's gross profit margin has been negative at -63.84% during the same period, indicating challenges in translating top-line growth to bottom-line profitability.
InvestingPro Tips:
- Legend Biotech holds more cash than debt on its balance sheet, which is a strong indicator of financial stability and could provide flexibility in funding ongoing research and development.
- Analysts are optimistic about the company's sales growth in the current year, which could be bolstered by the recent FDA approval of CARVYKTI® and its potential market impact.
For investors interested in a deeper dive into Legend Biotech's financial health and future prospects, there are additional InvestingPro Tips available at https://www.investing.com/pro/LEGN. In total, investors can access 9 more expert tips to guide their investment decisions. To make the most of this valuable resource, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. These insights could be particularly valuable considering the company's recent advancements and the competitive nature of the biotech sector.
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