Juno Therapeutics Stumbles Over FDA Clinical Hold

By Chris Lange Updated Jan 13, 5:57AM EST · Published Jul 8, 10:05AM EDT

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Juno Therapeutics Stumbles Over FDA Clinical Hold — © Thinkstock

Juno Therapeutics Inc. (NASDAQ: JUNO) saw its shares sink early on Friday after the U.S. Food and Drug Administration (FDA) levied a clinical hold on its leukemia treatment. The company announced that it has received notice from the FDA that a clinical hold has been placed on the Phase 2 clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the ROCKET trial.

The clinical hold was initiated after two patient deaths last week, which followed the recent addition of fludarabine to the pre-conditioning regimen.

Juno has proposed to the FDA to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. In response, the FDA has requested that Juno submit, as a Complete Response to the Clinical Hold: a revised patient informed consent form, a revised investigator brochure, a revised trial protocol and a copy of the presentation made to the agency Thursday. Juno will submit the requested information to the FDA this week.

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The company described itself as follows:

Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date.

Ahead of Friday’s move, Juno had underperformed the broad markets, with the stock down about 7% year to date. Over the past 52 weeks, the stock is down 17%.

Shares of Juno closed Thursday at $40.83 but were down about 27% to $29.74 shortly after Friday’s opening bell. The consensus analyst price target is $55.08, and the 52-week trading range is $22.37 to $57.82.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.