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Juno (JUNO) Suffers Setback, Pivotal Study on Clinical Hold
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Immuno-oncology focused company, Juno Therapeutics, Inc. , suffered a huge setback with the FDA placing a clinical hold on the company’s phase II study (ROCKET) on JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
Hold Based on Two Patient Deaths Last Week
The hold was placed after two patients died last week following the recent addition of fludarabine to the pre-conditioning regimen.
Juno to Submit Information to FDA
Juno has proposed the continuation of the study using JCAR015 with cyclophosphamide pre-conditioning alone. The FDA has asked the company to submit, as a Complete Response to the clinical hold, a revised patient informed consent form, a revised investigator brochure, a revised study protocol, and a copy of the presentation made to the agency yesterday. Juno intends to submit the information to the FDA this week.
Juno said that studies and plans for its other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected by the clinical hold.
Our Take
With JCAR015 being one of Juno’s most advanced pipeline candidates, the news about the clinical hold is a huge setback for the company. The ROCKET study is a pivotal study and the company was previously looking to gain accelerated approval in the U.S. in 2017. However, with a clinical hold in place, timelines will be pushed back.
Juno’s shares were down in pre-market trading. Other immuno-oncology focused companies like bluebird bio, Inc. (BLUE - Free Report) and Kite Pharma, Inc. witnessed a slight decline in share prices in after-market hours yesterday.
While Juno is a Zacks Rank #3 (Hold) stock, Kite is a Zacks Rank #2 (Buy) stock. Another well-ranked stock in the biotech sector is Biogen Inc. (BIIB - Free Report) , which also carries a Zacks Rank #2.
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Juno (JUNO) Suffers Setback, Pivotal Study on Clinical Hold
Immuno-oncology focused company, Juno Therapeutics, Inc. , suffered a huge setback with the FDA placing a clinical hold on the company’s phase II study (ROCKET) on JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
Hold Based on Two Patient Deaths Last Week
The hold was placed after two patients died last week following the recent addition of fludarabine to the pre-conditioning regimen.
Juno to Submit Information to FDA
Juno has proposed the continuation of the study using JCAR015 with cyclophosphamide pre-conditioning alone. The FDA has asked the company to submit, as a Complete Response to the clinical hold, a revised patient informed consent form, a revised investigator brochure, a revised study protocol, and a copy of the presentation made to the agency yesterday. Juno intends to submit the information to the FDA this week.
Juno said that studies and plans for its other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected by the clinical hold.
Our Take
With JCAR015 being one of Juno’s most advanced pipeline candidates, the news about the clinical hold is a huge setback for the company. The ROCKET study is a pivotal study and the company was previously looking to gain accelerated approval in the U.S. in 2017. However, with a clinical hold in place, timelines will be pushed back.
Juno’s shares were down in pre-market trading. Other immuno-oncology focused companies like bluebird bio, Inc. (BLUE - Free Report) and Kite Pharma, Inc. witnessed a slight decline in share prices in after-market hours yesterday.
JUNO THERAPEUTC Price
JUNO THERAPEUTC Price | JUNO THERAPEUTC Quote
While Juno is a Zacks Rank #3 (Hold) stock, Kite is a Zacks Rank #2 (Buy) stock. Another well-ranked stock in the biotech sector is Biogen Inc. (BIIB - Free Report) , which also carries a Zacks Rank #2.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>