Juno Shares Plunge as Drug Trial Placed on Hold After Patient Deaths
08 July 2016 - 7:30AM
Dow Jones News
Juno Therapeutics Inc. said a clinical hold was placed on its
trial of a potential leukemia treatment after two patient deaths
last week.
Juno shares fell 30% to $28.46 in after-hours trading
Thursday.
The Phase 2 trial of JCAR015 tested the drug in patients with
relapsed or refractory B cell acute lymphoblastic leukemia. As of
2015, the biopharmaceutical company said JCAR015 was its most
advanced product candidate. In June, the company reported favorable
JCAR015 results from a Phase 1 study.
The deaths occurred after the addition of fludarabine to the
pre-conditioning regimen. Juno has proposed to the U.S. Food and
Administration to continue the trial with cyclophosphamide
pre-conditioning alone.
Juno will submit a response to the FDA this week that includes
revisions to the trial protocol and patient consent forms.
The company said its plans for other CD19-directed CAR-T cell
product candidates, including JCAR017, aren't affected.
Seattle-based Juno launched in 2013 with discoveries by
scientists at Fred Hutchinson Cancer Research, Memorial Sloan
Kettering Cancer Center and the Seattle Children's Research
Institute.
Last year, Juno announced a 10-year collaboration with Celgene
Corp. focused on treatments for cancer and autoimmune diseases.
Celgene invested about $1 billion in Juno initially, including an
$849.8 million stock purchase and a $150 million payment.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
July 07, 2016 17:15 ET (21:15 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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