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Juno ROCKETs On Fast Clinical Hold Resolution

 
• By Mandy Jackson

The FDA lifted a clinical hold on the Phase II ROCKET clinical trial for Juno's lead CAR-T therapy candidate JCAR015 less than a week after it was instituted, allowing the company to proceed without using fludarabine in a pre-conditioning chemotherapy regimen.

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Juno Therapeutics Inc. soared in after-hours trading on July 12 following the company's late-day announcement that a clinical hold on its Phase II ROCKET clinical trial for the chimeric antigen receptor T-cell (CAR-T) therapy JCAR015 has been lifted just a few business days after the US FDA instituted the hold in response to three deaths in the study.

Seattle, Washington-based Juno fell more than 27% after the stock market closed on July 7 when the company first revealed the clinical hold, despite assurances that the FDA was likely...

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