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BGNE

BeiGene

$126.26

-3.65 (-2.81%)

06:07
10/12/18
10/12
06:07
10/12/18
06:07

BeiGene presents updated Phase 1 data on zanubrutinib

BeiGene announced updated results from the Phase 1 clinical trial of its investigational BTK inhibitor zanubrutinib, in an oral presentation at the 10th International Workshop on Waldenstrom's Macroglobulinemia. The IWWM meeting is taking place in New York City from October 11-13, 2018. "As we prepare our first U.S. New Drug Application filing for zanubrutinib, which we expect to file in the first half of 2019 in patients with Waldenstrom's Macroglobulinemia, we are pleased to update data in patients with WM from the Phase 1 trial that will support our filing. With more than 70 patients with WM now treated, we continue to see a high rate of deep and durable responses across genotypes, including high rates of overall, major, and very good partial responses," commented Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We believe that the maturing data across B-cell malignancies continue to support a multi-regional approval strategy for zanubrutinib, including the ongoing NDA review in China for zanubrutinib in patients with relapsed/refractory mantle cell lymphoma by The National Medical Products Administration. We are hopeful that zanubrutinib, if approved, will represent a valuable treatment option across the globe for patients with several forms of B-cell malignancy."

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BGNE BeiGene
$126.26

-3.65 (-2.81%)

07/23/18
PIPR
07/23/18
NO CHANGE
Target $200
PIPR
Overweight
BeiGene filing plans 6-12 months earlier than expected, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren says BeiGene's intention to file a new drug application for zanubrutinib in the first half of 2019 is 6-12 months earlier than he expected. He believes the accelerated filing makes sense based on the Fast Track designation and "differentiated data to date." Further, yesterday's preliminary topline data from a pivotal Chinese trial of tislelizumab "appears to suggest deeper and higher quality responses suggesting a potential best-in-class profile," Van Buren tells investors in a research note. He reiterates an Overweight rating on BeiGene with a $200 price target.
08/09/18
PIPR
08/09/18
NO CHANGE
Target $200
PIPR
Overweight
BeiGene Q2 commercial performance encouraging, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren is encouraged by BeiGene's commercial performance in Q2. Product sales suggest a $125MM run-rate, which represents a doubling from Q4, Van Buren tells investors in a post-earnings research note. Further, the analyst believes BeiGene continues to make "significant progress" across its development portfolio. He's optimistic towards the potential for continued value creation from the pipeline and keeps an Overweight rating on the shares with a $200 price target.
09/17/18
GUGG
09/17/18
INITIATION
Target $214
GUGG
Buy
BeiGene initiated with a Buy at Guggenheim
Target $214.
09/24/18
LEER
09/24/18
INITIATION
Target $215
LEER
Outperform
BeiGene initiated with an Outperform at Leerink
Leerink analyst Andrew Berens started BeiGene with an Outperform rating and $215 price target.

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LYB

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KALU

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ALDR

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HL

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BMY

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$50.99

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Tenneco

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TEN

Tenneco

$36.29

0.76 (2.14%)

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XRX

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TWTR

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ALLY

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DAL

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REN

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ORI

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VIX

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$0.00

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