Juno Therapeutics, Inc. and partner Celgene Corporation , announced that the FDA has granted Breakthrough Therapy designation to their investigational candidate, JCAR017, for the treatment of relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and Primary Mediastinal B-cell Lymphoma (PMBCL).
Further, the candidate was granted Priority Medicines (PRIME) eligibility for r/r DLBCL by the European Medicines Agency (EMA).
Juno’s share price has tumbled 36% in the past one month, compared with the 4.1% fall witnessed by the Zacks classified Medical-Biomedical and Genetics industry.
The FDA’s Breakthrough Therapy designation is expected to expedite the development and review of drugs that are intended to treat serious or life threatening conditions, and provide access to patients as soon as possible.
JCAR017 is the most advanced candidate in Juno’s pipeline. Note that the candidate already enjoys orphan drug designation for the treatment of acute lymphoblastic leukemia (ALL), DLBCL and chronic lymphocytic leukemia (CLL). Earlier this month, the company presented encouraging preliminary clinical data from a phase I study (TRANSCEND) on JCAR017 for the treatment of r/r aggressive NHL at the annual meeting of American Society of Hematology (ASH).
Juno intends to initiate a pivotal trial in patients with r/r DLBCL in the U.S. in 2017. JCAR017 is also being studied in a phase II study on children with r/r ALL. The company expects to obtain an FDA approval for the candidate for the treatment of NHL as early as 2018.
Juno is looking to revolutionize cancer treatments by engaging the body’s immune system to treat cancer. The company is developing cell-based cancer immunotherapies based on CAR and high-affinity TCR technologies with the goal to activate a patient’s own T-cells to recognize and kill cancer cells. JCAR017 uses CAR T-cell technology to target CD19. CD19 is a protein expressed on the surface of almost all B cell leukemias and lymphomas. Other candidates using this technology are JCAR014 and JCAR015.
Zacks Rank & Key Picks
Juno currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector include Cambrex Corporation and Heska Corporation . Both Cambrex and Heska sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased 3.7% for 2016 and 4.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 14.9% year to date.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 85.5% year to date.
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Juno Gets Breakthrough Therapy Status for Lymphoma Drug
Juno Therapeutics, Inc. and partner Celgene Corporation , announced that the FDA has granted Breakthrough Therapy designation to their investigational candidate, JCAR017, for the treatment of relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and Primary Mediastinal B-cell Lymphoma (PMBCL).
Further, the candidate was granted Priority Medicines (PRIME) eligibility for r/r DLBCL by the European Medicines Agency (EMA).
Juno’s share price has tumbled 36% in the past one month, compared with the 4.1% fall witnessed by the Zacks classified Medical-Biomedical and Genetics industry.
The FDA’s Breakthrough Therapy designation is expected to expedite the development and review of drugs that are intended to treat serious or life threatening conditions, and provide access to patients as soon as possible.
JCAR017 is the most advanced candidate in Juno’s pipeline. Note that the candidate already enjoys orphan drug designation for the treatment of acute lymphoblastic leukemia (ALL), DLBCL and chronic lymphocytic leukemia (CLL). Earlier this month, the company presented encouraging preliminary clinical data from a phase I study (TRANSCEND) on JCAR017 for the treatment of r/r aggressive NHL at the annual meeting of American Society of Hematology (ASH).
Juno intends to initiate a pivotal trial in patients with r/r DLBCL in the U.S. in 2017. JCAR017 is also being studied in a phase II study on children with r/r ALL. The company expects to obtain an FDA approval for the candidate for the treatment of NHL as early as 2018.
Juno is looking to revolutionize cancer treatments by engaging the body’s immune system to treat cancer. The company is developing cell-based cancer immunotherapies based on CAR and high-affinity TCR technologies with the goal to activate a patient’s own T-cells to recognize and kill cancer cells. JCAR017 uses CAR T-cell technology to target CD19. CD19 is a protein expressed on the surface of almost all B cell leukemias and lymphomas. Other candidates using this technology are JCAR014 and JCAR015.
Zacks Rank & Key Picks
Juno currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector include Cambrex Corporation and Heska Corporation . Both Cambrex and Heska sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased 3.7% for 2016 and 4.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 14.9% year to date.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 85.5% year to date.
JUNO THERAPEUTC Price
JUNO THERAPEUTC Price | JUNO THERAPEUTC Quote
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time? Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>