Eli Lilly's stock surged 5.06% during intraday trading on Friday, driven by significant positive regulatory news for its drug candidate.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Jaypirca (pirtobrutinib) for approval in the European Union. The recommendation is for the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy and is based on positive results from two Phase 3 clinical trials that met their primary endpoints.
The application has now been referred to the European Commission, with a final marketing authorization decision expected within the next one to two months. Eli Lilly has also submitted the trial results to the U.S. Food and Drug Administration for approval, with a decision anticipated in the second half of this year.
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