On Wednesday, JPMorgan reiterated its Overweight rating on shares of Legend Biotech Corp. (NASDAQ:LEGN), ahead of the upcoming FDA advisory committee meeting set to discuss the company's cancer treatment, Carvykti.
The focus of the meeting will be on the imbalance of early deaths observed in the CARTITUDE-4 study, which, according to the analyst, were mainly among patients who had not yet received Carvykti.
Despite these concerns, the analyst believes the overall efficacy and safety data of Carvykti present a compelling profile, highlighting the strong progression-free survival (PFS) benefit and an overall survival (OS) rate that continues to improve with further follow-up.
The advisory committee meeting, scheduled for Friday, will be a significant event for Legend Biotech as the panel reviews the data and determines the potential of Carvykti in the treatment landscape. The analyst noted that issues such as neurotoxicity and secondary malignancies, which have been investor concerns, do not seem to be a particular point of focus in the briefing document for the meeting.
Management at Legend Biotech expressed confidence in the expansion of Carvykti into the second line and beyond settings during a conversation with the analyst. The company is reportedly looking at multiple avenues to expand its capacity to meet the strong demand for the treatment, as current demand significantly exceeds supply.
The analyst's comments suggest optimism for Carvykti's approval and future market performance, emphasizing the treatment's robust PFS advantage and improving OS figures. Legend Biotech's fundamentals are viewed positively by JPMorgan, with an anticipation of a favorable outcome from the advisory committee meeting that aligns with the company's expectations for Carvykti's role in cancer treatment.
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