Legend Biotech’s CAR T Cell Therapies See FDA REMS Removal and EMA Label Update

Legend Biotech ( (LEGN) ) has issued an announcement.

On June 26, 2025, the FDA removed the Risk Evaluation and Mitigation Strategies (REMS) for Legend Biotech’s BCMA- and CD19-directed CAR T cell immunotherapies, streamlining patient monitoring and updating product labeling. By June 30, 2025, over 6,500 patients had been treated with CARVYKTI®, reflecting the evolving understanding of its safety profile. Additionally, the European Medicines Agency recommended a label update for CARVYKTI® to include warnings about potential immune-mediated enterocolitis and gastrointestinal perforation, highlighting ongoing safety considerations.

The most recent analyst rating on (LEGN) stock is a Buy with a $80.00 price target. To see the full list of analyst forecasts on Legend Biotech stock, see the LEGN Stock Forecast page.

Spark’s Take on LEGN Stock

According to Spark, TipRanks’ AI Analyst, LEGN is a Neutral.

Legend Biotech’s strong revenue growth and positive earnings call outlook are offset by ongoing profitability challenges and cash flow issues. The technical momentum is favorable, but valuation concerns persist due to the negative P/E ratio. The company’s strategic initiatives and solid cash position support a promising long-term outlook, but short-term risks remain.

To see Spark’s full report on LEGN stock, click here.

More about Legend Biotech

Legend Biotech is a biotechnology company focused on developing innovative cell therapies, particularly chimeric antigen receptor (CAR) T cell therapies, for cancer treatment. The company is known for its products targeting BCMA and CD19, and it operates in both clinical trial and commercial settings.

Average Trading Volume: 1,833,581

Technical Sentiment Signal: Hold

Current Market Cap: $6.37B

For detailed information about LEGN stock, go to TipRanks’ Stock Analysis page.