Juno Therapeutics Inc JUNO announced late Thursday it has received notice from the U.S. Food and Drug Administration that it has placed a clinical hold on its Phase II clinical trial of JCAR015 in patients with relapsed or refractory B cell acute lymphoblastic leukemia.
The trial, also known as the "ROCKET" trial, was put on hold by the FDA after two patient deaths were reported last week.
Shares of Juno sank more than 30 percent Friday morning.
Juno noted the FDA requested that it submit a revised patient informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the presentation made to the agency. The company plans to submit the requested information this week.
Biotech Sector Under Heavy Selling Pressure
Juno's announcement sent a shock wave across the biotechnology sector.
Kite Pharma Inc KITE, a clinical-stage biopharmaceutical company that focuses on the development and commercialization of cancer immunotherapy products to eradicate cancer cells, saw its shares trade lower by nearly 10 percent.
Cellectis SA (ADR) CLLS, a France-based company that specializes in the research, development and commercialization of rational genome engineering technologies, saw its shares trading lower by nearly 7 percent.
Shares of bluebird bio Inc BLUE were lower by around 1 percent as the negative sentiment in the space extended to the company that develops transformative gene therapies for severe genetic and rare diseases.
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