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BGNE

BeiGene

$169.98

5.95 (3.63%)

16:43
07/22/18
07/22
16:43
07/22/18
16:43

BeiGene planning to pursue accelerated approval in U.S. of Zanubrutinib in WM

BeiGene announced that its investigational BTK inhibitor zanubrutinib has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with Waldenstrom macroglobulinemia, or WM. Based on BeiGene's discussions with the FDA, internal review of available data from its global Phase 1 trial of zanubrutinib in patients with WM, and supported by the Fast Track Designation, BeiGene is preparing to submit in the first half of 2019 a New Drug Application to pursue an accelerated approval of zanubrutinib for patients with WM based on results from the global Phase 1 study. A final determination to submit the NDA will be made subsequent to the pre-NDA meeting with FDA after obtaining mature data from the study this fall. In addition to the global Phase 1 trial of zanubrutinib, which enrolled 76 WM patients to date, zanubrutinib is also being tested in a global Phase 3 clinical trial in patients with WM comparing zanubrutinib to ibrutinib, a currently approved BTK inhibitor. BeiGene announced that this global Phase 3 study has completed patient enrollment. In addition, zanubrutinib is being tested in a global Phase 3 clinical trial as a first-line treatment for patients with chronic lymphocytic leukemia and a Phase 2 clinical trial in patients with relapsed or refractory follicular lymphoma in combination with GAZYVA. In China, BeiGene has completed enrollment in three pivotal Phase 2 clinical trials of zanubrutinib in patients with mantle cell lymphoma, CLL and WM, and expects to file an NDA in China for MCL this year. BeiGene is also planning a Phase 3 trial for a head-to-head comparison of zanubrutinib versus ibrutinib in patients with relapsed/refractory CLL/small lymphocytic lymphoma. As of May 7, 2018, more than 1,200 patients have been enrolled in the zanubrutinib development program.

BGNE BeiGene
$169.98

5.95 (3.63%)

05/14/18
FBCO
05/14/18
INITIATION
FBCO
Outperform
BeiGene initiated with an Outperform at Credit Suisse
05/14/18
05/14/18
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. General Electric (GE) initiated with a Buy at Gabelli. 2. Western Digital (WDC) initiated with an Overweight at JPMorgan. 3. GrafTech (EAF) initiated with an Overweight at JPMorgan and an Outperform at RBC Capital. 4. Surface Oncology (SURF) initiated with an Outperform at Evercore ISI and Cowen as well as a Neutral at Goldman Sachs. 5. BeiGene (BGNE) initiated with an Outperform at Credit Suisse. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
05/18/18
MAXM
05/18/18
NO CHANGE
Target $225
MAXM
Buy
BeiGene price target raised to $225 from $200 at Maxim
Maxim analyst Jason McCarthy raised his price target on BeiGene to $225 and kept his Buy rating after the company's announced pivotal study to move into ovarian cancer treatment in China. The analyst notes that as a China-based company, BeiGene has a "distinct advantage" in potentially bringing a PARP inhibitor candidate to that market. McCarthy also points to the China market opportunity, where the majority of 50K ovarian cancer cases are moving to maintenance therapy.
06/15/18
PIPR
06/15/18
NO CHANGE
Target $200
PIPR
Overweight
Piper says BeiGene update suggests zanubrutinib at least in line with other BTKs
After BeiGene presented results on its investigational BTK inhibitor zanubrutinib at the EHA meeting, Piper Jaffray analyst Tyler Van Buren said the update suggests zanubrutinib is "at least in line with" the other BTKs and has potential for eventual differentiation. He was encouraged to see a significant increase in the complete response rate for mantle cell lymphoma and thinks the data will support an approval in China next year, he tells investors. Van Buren keeps an Overweight rating and $200 price target on BeiGene shares.

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