Gilead’s Kite Receives FDA Approval For Yescarta Immunotherapy; Street Sees 17% Upside

Kite, a unit of Gilead Sciences, announced that the US Food and Drug Administration (FDA) has approved its Yescarta T cell immunotherapy. The therapy is a first-of-its-kind treatment for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

The Gilead (GILD) company said that the US regulator’s decision was based on ZUMA-5, a single-arm, open-label study, that demonstrated 91% of patients with relapsed or refractory FL (n=81) responded to Yescarta. Shares of the biopharmaceutical company increased 2.2% to close at $64.62 on March 5.

Kite CEO Christi Shaw said, “As we look to bring the hope of survival to more patients in need, today’s FDA decision represents a real step forward in our commitment in hematologic malignancies.” (See Gilead stock analysis on TipRanks)

“Advancing CAR T therapies for patients across lymphomas remains a cornerstone of our cell therapy development program, and we are excited about the potential of Yescarta for patients with indolent follicular lymphoma,” Shaw added.

On Feb. 10, Mizuho Securities analyst Salim Syed maintained a Buy rating and a price target of $81 (25.4% upside potential) on the stock after Galapagos and Gilead discontinued ISABELA Phase 3 clinical studies.

The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating. That’s based on 11 analysts suggesting a Buy, 9 analysts recommending a Hold and 1 analyst suggest a Sell. The average analyst price target of $75.73 implies 17.2% upside potential to current levels. Shares have increased 7.5% so far this year.

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