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    BGNE   US07725L1026

BEIGENE, LTD.

(BGNE)
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BeiGene, Ltd. Announces U.S. FDA Acceptance of Biologics License Application for Tislelizumab in Esophageal Squamous Cell Carcinoma

09/13/2021 | 12:00am EST

BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date is July 12, 2022. The BLA submission is based on results from RATIONALE 302, a randomized, open-label, multicenter global Phase 3 trial (NCT03430843) designed to evaluate the efficacy and safety of tislelizumab when compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced or metastatic ESCC. Results of this trial were presented at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021). The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials. In addition to the United States, tislelizumab is also under regulatory review in China as a treatment for patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy.


ę S&P Capital IQ 2021
All news about BEIGENE, LTD.
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11/24BeiGene to Conduct Price Consultations on Nov. 29 for Planned Shanghai IPO
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11/23BeiGene Bags EU Approval for Blood Cancer Drug Brukinsa
MT
11/23BeiGene Completes Land Purchase for US Manufacturing, R&D Center
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11/23EU Approves BeiGene's Cancer Medicine as Treatment for Waldenström's Macroglobulinemia
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11/23BeiGene, Ltd. Closes on Property for New U.S. Manufacturing and Clinical R&D Center
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11/23BEIGENE : Launches Proposed Initial Public Offering on the STAR Market in China - Form 8-K
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11/23BeiGene's Blood Cancer Treatment Receives European Commission Approval
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Analyst Recommendations on BEIGENE, LTD.
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Financials (USD)
Sales 2021 1 184 M - -
Net income 2021 -1 240 M - -
Net cash 2021 3 103 M - -
P/E ratio 2021 -26,3x
Yield 2021 -
Capitalization 32 613 M 32 613 M -
EV / Sales 2021 24,9x
EV / Sales 2022 21,9x
Nbr of Employees 7 600
Free-Float 67,7%
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Technical analysis trends BEIGENE, LTD.
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Income Statement Evolution
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Mean consensus BUY
Number of Analysts 14
Last Close Price 347,53 $
Average target price 435,26 $
Spread / Average Target 25,2%
EPS Revisions
Managers and Directors
John V. Oyler Chairman & Chief Executive Officer
Xiao Bin Wu President & Chief Operating Officer
Julia Wang Chief Financial & Accounting Officer
Jane E. Huang Chief Medical Officer-Hematology
Lai Wang Global Head-Research & Development
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