Juno Therapeutics Inc (NASDAQ:JUNO) Shares Down on FDA Clinical Hold Notice

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Juno Therapeutics Inc (NASDAQ:JUNO) shares were down 31.87% to $27.81 on Friday when the company received a notice that the U.S. Food and Drug Administration has placed a clinical hold on its Phase II trials on JCAR015. This was initiated after two adult patients with relapsed or refractory B cell acute lymphoblastic leukemia died following the addition of fludarabine to the pre-conditioning regimen.

In response, Juno Therapeutics proposed that it continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. The FDA then required the company to submit a revised patient informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the recent presentation made to the agency as a Complete Response to the Clinical Hold notice.

The company’s trials and plans for its other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected with this Clinical Hold notice but investors are wary that the Clinical Hold could dampen the chances of JCAR015 being approved and made commercially available, thereby limiting the company’s revenue streams.

Stock analysts from Barclays, Goldman Sachs, Guggenheim, JPMorgan, and SunTrust Robinson downgraded their price targets for Juno Therapeutics following this announcement. The stock is already down roughly 7% so far this year and lower by 17% over the past 52 weeks. Barclays cut its price target from $35 to $48 while Goldman Sachs lowered its forecast from $39 to $36. Further updates on these clinical trials could lead to short-term bounces but the outlook has turned grim.

Juno Therapeutics is a biopharmaceutical company that is developing cell-based cancer immunotherapies based on its chimeric antigen receptor and T cell receptor echnologies to genetically engineer T cells to recognize and kill cancer cells. Its product candidates include JCAR015, JCAR017 and JCAR014. It has a market cap of $2.00 billion at 105.54 million shares outstanding. Shares have been trading in a 52-week range of $22.37 to $57.82.

 

DISCLAIMER: There is a substantial risk of loss with any speculative asset, especially small cap stocks. The opinions expressed are those of the author, and do not constitute recommendations to buy or sell a stock. Do your own research before committing capital.

 

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