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KITE

Acquired by GILD 9/17

$113.55

0.97 (0.86%)

07:45
08/08/17
08/08
07:45
08/08/17
07:45

Kite Pharma submits IND application for KITE-585 to FDA

Kite Pharma announced the submission of an Investigational New Drug application with the U.S. Food and Drug Administration to initiate a Phase 1, first-in-human trial of KITE-585, a CAR-T cell therapy engineered to target B-cell maturation antigen in patients with relapsed/refractory multiple myeloma. "KITE-585 has the potential to become Kite's next significant advance in cell therapy for patients with cancer. It is the result of an extensive preclinical development effort that included candidate screening, engineering, and testing by Kite's internal research team and it reflects the company's deep experience in CAR design and cellular therapeutics," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "As we look ahead, we are confident that the cutting-edge design and manufacturing process of KITE-585 together with our proven capability with engineered T cells will support rapid execution of the clinical program." KITE-585 is an anti-BCMA CAR construct designed for high binding affinity to BCMA expressed on the cell surface. KITE-585 contains a receptor derived from a fully human monoclonal antibody and a CD28 costimulatory domain intended for optimized T-cell expansion and function. In preclinical studies, KITE-585 demonstrated activity across a range of low and high BCMA expressing targets and its activity was not impaired by soluble BCMA. In the presence of cell-bound BCMA, KITE-585 induced polyfunctional T cell expansion, and no tonic signaling in its absence. Advanced processes and materials used in the manufacturing of KITE-585 are designed to achieve enhanced cell potency.

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KITE Acquired by GILD 9/17
$113.55

0.97 (0.86%)

07/10/17
JEFF
07/10/17
NO CHANGE
Target $121
JEFF
Buy
Jefferies ups Kite target to $121 on 'relatively benign' FDA docs
Jefferies analyst Biren Amin raised his price target for Kite Pharma (KITE) shares to $121 from $101 after the FDA posted briefing documents ahead of the July 12 committee meeting disusing Novartis' (NVS) CAR-T therapy CTL019. The documents for the first CAR-T therapy seem "relatively benign," Amin tells investors in a research note. The FDA's view of CAR-T therapies looks in-line with expectations, but the agency may require long-term follow-up of patients to assess for risk of secondary malignancies, Amin writes. He keeps a Buy rating on Kite Pharma. The stock in late morning trading is down 3% to $102.55.
07/13/17
SBSH
07/13/17
NO CHANGE
SBSH
Novartis vote bodes well for Kite and Juno, says at Citi
Citi analyst Robyn Karnauskas believes the FDA's unanimous vote in favor of Novartis' (NVS) CAR-T bodes well for Kite Pharma (KITE) and Juno Therapeutics (JUNO). Yesterday's panel meeting provides a preview of what Kite can expect ahead of its November 29 FDA action date, Karnauskas tells investors in a research note. She believes the expert commentary from the panel has "overarching implications" for Kite and Juno, both of which are developing CAR-T therapies for multiple indications.
07/13/17
MAXM
07/13/17
DOWNGRADE
MAXM
Hold
Kite Pharma downgraded to Hold from Buy at Maxim
07/13/17
07/13/17
DOWNGRADE

Hold
Kite Pharma downgraded to Hold at Maxim
As previously reported, Maxim analyst Jason McCarthy downgraded Kite Pharma to Hold from Buy as he believes approval and success in relapsed/refractory blood cancers is already being factored in at the stock's current valuation. While "there is much more to come" from T-cell based oncology therapies, the focus for Kite is set to shift to "not if, but when and how much," McCarthy tells investors.

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