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News Breaks
August 25, 2014
16:38 EDTKITEKite Pharma announces positive phase 1-2a results, sees 92% objective response
Kite Pharma announced the publication of clinical results in a cohort of patients demonstrating the potential to treat aggressive non-Hodgkin's lymphoma with an anti-CD19 chimeric antigen receptor, or CAR, T cell therapy. Kite's most advanced product candidate, KTE-C19, is an anti-CD19 CAR T cell therapy that involves genetically modifying a patient's T cells to express a CAR that is designed to target CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. The findings from an ongoing Phase 1-2a clinical trial funded by Kite and conducted by the Surgery Branch of the National Cancer Institute, or NCI, demonstrated that in 12 out of 13 evaluable patients with advanced B-cell malignancies, administration of anti-CD19 CAR T cells resulted in complete remission in eight patients and partial remission in four patients, representing an overall objective response rate of 92%. Of seven evaluable patients with chemotherapy-refractory Diffuse Large B-cell Lymphomr, or DLBCL, four achieved complete remission, three of which are ongoing with durations ranging from 9 to 22 months. "We are greatly encouraged by the strong results we have seen from our joint lead clinical program with the NCI," commented Arie Belldegrun, Kite's president and CEO. "Based on this substantial progress, Kite plans to file an IND in Q4 of this year to initiate a Phase 1-2 single-arm multicenter clinical trial of KTE-C19 in patients with DLBCL who have failed two or more lines of therapy. We are excited to advance this promising therapy and anticipate commencing patient enrollment in our DLBCL clinical trial in the first half of 2015."
News For KITE From The Last 14 Days
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November 17, 2014
08:11 EDTKITEKite Pharma receives positive opinion for KTE-C19 orphan drug designation in EU
Kite Pharma announced that the European Medicines Agency, or EMA, Committee for Orphan Medicinal Products, or COMP, has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of diffuse large B cell lymphoma, or DLBCL. KTE-C19 is an anti-CD19 CAR T cell therapy that involves genetically modifying a patient's T cells to express a CAR that is designed to target CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. The COMP, a committee of the EMA, adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission for endorsement of the opinion. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
November 14, 2014
15:22 EDTKITEKite Pharma reports Q3 EPS (24c), consensus (23c)
As of September 30, Kite had $195.4M in cash, cash equivalents, and marketable securities.
November 12, 2014
11:17 EDTKITELeerink major pharma & biotech analysts hold analyst/industry conference call
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November 11, 2014
15:43 EDTKITELeerink major pharma & biotech analysts hold analyst/industry conference call
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November 7, 2014
08:40 EDTKITEKite Pharma price target raised to $51 from $42 at Canaccord
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