Lyell Immunopharma (LYEL) said Tuesday its therapy candidate for treating relapsed or refractory large B-cell lymphoma, LYL314, has received the US Food and Drug Administration's Regenerative Medicine Advanced Therapy designation.
The RMAT designation provides all the benefits of Fast Track and Breakthrough Therapy designations, Lyell said. The FDA's designation drew on initial findings from an ongoing phase 1/2 trial, the company said.
Two pivotal trials are expected to start in mid-2025 and early 2026, the company added.
Shares of the company were up 3% in recent Tuesday trading.
Price: 0.46, Change: +0.01, Percent Change: +3.13
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