Health and Healthcare
How Badly Analysts Ditched Juno Therapeutics After Clinical Hold
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Juno Therapeutics Inc. (NASDAQ: JUNO) saw its shares sink on Friday after the U.S. Food and Drug Administration (FDA) levied a clinical hold on its leukemia treatment. As a result a few analysts gave their two cents on the decision, and across the board they took a more negative tone with this company.
24/7 Wall St. has included some highlights from the FDA announcement, as well as what analysts are saying after the fact.
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.
A few analysts weighed in on Juno after the news:
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 ended trading on Friday down almost 32% at $27.81, with a consensus analyst price target of $55.08 and a 52-week trading range of $22.37 to $57.82.
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