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KITE

Acquired by GILD 9/17

$111.43

2.55 (2.34%)

08:38
07/31/17
07/31
08:38
07/31/17
08:38

Kite Pharma files CAR-T MAA in Europe for axicabtagene ciloleucel

Kite Pharma announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma who are ineligible for autologous stem cell transplant. This application represents the first chimeric antigen receptor T-cell therapy submitted to the EMA. Axicabtagene ciloleucel is currently under review by the U.S. Food and Drug Administration, and the FDA has set a Prescription Drug User Fee Act action date of November 29. The MAA for axicabtagene ciloleucel is supported by data from the ZUMA-1 trial, which met the primary endpoint of objective response rate, with 82% of patients achieving a response after a single infusion of axicabtagene ciloleucel. At a median follow-up of 8.7 months, 44% of patients were in ongoing response, which included 39% of patients in complete response. The most common Grade 3 or higher adverse events included cytokine release syndrome and neurologic events, which were generally reversible.

  • 28

    Aug

  • 29

    Nov

KITE Acquired by GILD 9/17
$111.43

2.55 (2.34%)

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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