Gilead Cell-Therapy Drug Yescarta Gets FDA Approval

By Jonathan D. Rockoff

Gilead Sciences Inc.'s $11 billion bet on Kite Pharma Inc. is poised to pay off, with the approval Wednesday of Kite's flagship cell-therapy treatment for advanced lymphoma patients.

The therapy, known as a Car-T treatment, uses genetically engineered T-cells to attack the blood cancer. It is the second such therapy to get a regulatory green light, after Novartis AG's Car-T drug Kymriah was approved in late August.

Like Novartis's therapy, which was priced at $475,000, Gilead's treatment commands a six-figure list price. Gilead said the therapy, dubbed Yescarta, will have a list price of $373,000.

Yescarta, the crown jewel of the Gilead's recent purchase of biotech Kite Pharma, has been among the most highly anticipated new drugs on Wall Street, which estimates the therapy will have $1.7 billion in world-wide sales in five years, according to EvaluatePharma, a market-research firm.

Sales of Yescarta should bolster Gilead's efforts to diversify beyond its legacy drugs for HIV/AIDS and hepatitis C as their sales slow.

Yet Gilead, which was criticized by patients, doctors and lawmakers for the high list price of hepatitis C treatment Sovaldi, may face a new round of scrutiny over Yescarta's price tag.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com

(END) Dow Jones Newswires

October 18, 2017 18:22 ET (22:22 GMT)

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