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Gilead’s Yescarta Immunotherapy Wins FDA Approval

Kite, a unit of biopharmaceutical company Gilead Sciences (NASDAQ: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved its Yescarta CAR T-cell immunotherapy. The therapy is a first-of-its-kind treatment for adult patients with relapsed or refractory large B-cell lymphoma (LBCL). These patients include individuals who have received first-line therapy in the last 12 months. 

Supporting Data 

The U.S. regulator’s decision was based on ZUMA-7, a randomized, open-label Phase 3 study. It was designed to evaluate the safety and efficacy of Yescarta versus the current standard of care (SOC) for second-line therapy. Around 359 patients participated in the study, which showed that the primary endpoint is event-free survival (EFS). 

Annually, over 18,000 people are diagnosed with LBCL in the U.S., with about 30%-40% of patients requiring second-line treatment. 

Official Comments 

On reaching the milestone, Kite CEO Christi Shaw said, “Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey.” 

Smart Score 

According to TipRanks’ Smart Score system, Gilead gets a 7 out of 10, which indicates that the stock is likely to perform in line with market averages. 

Wall Street’s Take 

Recently, Robert W. Baird analyst Brian Skorney maintained a Hold rating on Gilead and a price target of $63 (5.58% upside potential). 

The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating. That’s based on eight analysts suggesting a Buy, nine analysts recommending a Hold, and one analyst suggesting a Sell. The average Gilead price target of $71.24 implies 19.39% upside potential to current levels. Shares have decreased 6.1% over the past year.

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