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Investing.com - H.C. Wainwright has reiterated a Buy rating and $75.00 price target on Legend Biotech Corp . (NASDAQ:LEGN), which has shown strong momentum with an 8.56% gain over the past week. The stock, currently trading near $36, remains well-supported by analysts, with targets ranging from $53 to $94, according to InvestingPro data.
On June 26, the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) for CARVYKTI that removes the risk evaluation and mitigation strategy (REMS) requirements. The FDA determined that a REMS is no longer necessary to ensure the benefits of the cancer treatment outweigh its risks.
The labeling update includes reduced monitoring requirements, instructing patients to remain within proximity of a healthcare facility for at least two weeks instead of four weeks previously. Patients are now advised to avoid driving for two weeks rather than eight weeks as previously required.
Separately, on June 25, the European Medicines Agency (EMA) recommended adding a warning to CARVYKTI’s product characteristics regarding immune-mediated enterocolitis, which may emerge months after infusion and could be refractory to corticosteroid treatment.
More than 6,500 patients have been treated with CARVYKTI to date, and H.C. Wainwright believes physicians are well-acquainted with the therapy’s profile. The firm expects the FDA’s changes could help accelerate CARVYKTI’s launch in the second-line-plus setting in the United States. This expansion potential is particularly significant given Legend’s impressive 112% revenue growth over the last twelve months. For deeper insights into Legend Biotech’s growth prospects and comprehensive financial analysis, check out the detailed Pro Research Report available on InvestingPro.
In other recent news, Legend Biotech Corporation reported significant findings from the CARTITUDE-1 study, showing that one-third of patients with relapsed/refractory multiple myeloma remained progression-free for at least five years after a single infusion of CARVYKTI. The study, presented at the American Society of Clinical Oncology Annual Meeting, highlighted a median overall survival of 60.7 months, with consistent safety data. Additionally, the company shared updates from the CARTITUDE-4 trial, which demonstrated improved progression-free survival and overall survival compared to standard therapies. RBC Capital reaffirmed its Outperform rating for Legend Biotech, citing the company’s undervaluation and potential growth opportunities for CARVYKTI. BMO Capital also maintained an Outperform rating, emphasizing CARVYKTI’s best-in-class status and outpatient dosing advantage. Meanwhile, TD Cowen reiterated a Buy rating, noting robust sales growth for CARVYKTI, especially in earlier treatment lines, and the company’s manufacturing success rate of 97%. TD Cowen highlighted that Legend Biotech’s financial outlook remains strong, with a $1.0 billion cash runway projected to lead into profitability by 2026. These developments reflect Legend Biotech’s ongoing commitment to advancing cell therapy treatments and its strategic positioning in the market.
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