Gilead Sciences Inc. saw its shares climb 2.1% to close at $152.50 on Friday, marking a new 52-week high for the biopharmaceutical giant. The surge followed a regulatory milestone from the U.S. Food and Drug Administration concerning the company's CAR-T cell therapy, Yescarta.
FDA Clears Expanded Use for Yescarta
The FDA approved a label update for Yescarta, a therapy developed by Gilead's Kite unit, removing a prior usage restriction. The update allows the treatment to be used for patients with relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of brain lymphoma. The decision was based on Phase 1 trial data sponsored by the Dana-Farber Cancer Institute.
"This label expansion provides clinicians with important evidence for a patient population that has had very limited treatment alternatives," a company statement noted, citing commentary from a Dana-Farber specialist. Kite's head of research and development highlighted that the move "expands access" to a long-overlooked group.
Insider Trading and Market Context
On the same day, CEO Daniel O'Day exercised options for 115,640 shares at $66.01 each and sold them at approximately $150 per share, according to a securities filing. The transactions were executed under a pre-arranged Rule 10b5-1 trading plan, which schedules insider sales in advance to avoid allegations of trading on non-public information.
The rally sets a high bar for Gilead as it prepares to report its fourth-quarter and full-year 2025 financial results after the market closes on Tuesday, February 10. Management will host a webcast at 4:30 p.m. Eastern Time. Analysts suggest that any disappointment in guidance or uncertainty in management's outlook could quickly reverse the stock's recent gains.
While the FDA's decision is a positive development, its commercial impact may be tempered by the therapy's niche patient population, along with ongoing challenges related to safety profiles, access, and reimbursement. The broader pharmaceutical sector also continues to face scrutiny over drug pricing, a persistent headwind for the industry.