On Thursday, BMO Capital Markets sustained its positive outlook on Legend Biotech Corp (NASDAQ:LEGN), maintaining an Outperform rating and a $90.00 price target for the company's shares. The firm's stance is bolstered by briefing documents indicating a favorable overall survival benefit for Legend Biotech's Carvykti, which could lead to its approval.
In a recent follow-up study, Carvykti showed a 77% overall survival rate at 29 months, compared to 64% in the standard of care, reflecting a hazard ratio of 0.57. This suggests a significant overall survival benefit. Despite the FDA's concerns about a higher death rate in the Carvykti arm during the initial ten months, BMO Capital does not view this as a significant obstacle to approval. The deaths were mostly unrelated to Carvykti, and the long-term benefits in terms of overall survival and progression-free survival are considered substantial.
The firm anticipates a favorable vote from the Oncologic Drugs Advisory Committee (ODAC) on March 15, 2024, and ultimately expects approval of Carvykti by the FDA on April 5, 2024. The analyst's comments reflect confidence in the drug's profile and the regulatory process, suggesting a strong potential for market approval.
Legend Biotech's Carvykti is under scrutiny for its efficacy and safety profile, with the FDA's review process being a critical phase for the company. BMO Capital's analysis and expectations are based on the available data and the upcoming ODAC review, pointing to a promising future for the treatment if approved.
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