The FDA placed a clinical hold on a registrational trial of Iovance Biotherapeutics’ tumor-infiltrating lymphocyte, or TIL, therapy LN-145 after a patient death in the study.
The hold puts a dent in the development of Iovance’s second-most advanced treatment candidate, and investors sent its shares $IOVA down more than 20% at Wednesday’s opening bell. Iovance had expected to complete enrollment in the second half of next year in the hopes of filing for approval in post-anti-PD-1 non-small cell lung cancer, or NSCLC, it said in November.
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