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Stock impact report

BioLineRx Announces Receipt of FDA Biological Product Designation for Novel Cancer Immunotherapy Candidate AGI-134

BioLineRx Ltd. - American Depositary Shares (BLRX) 
Last biolinerx ltd. - american depositary shares earnings: 5/14 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: ir.biolinerx.com
Company Research Source: PR Newswire
TEL AVIV, Israel, Nov. 20, 2018 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that the U.S. Food and Drug Administration (FDA) has granted the Biological Product Designation for AGI-134, the Company's novel immunotherapy compound. This designation provides the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA. This regulatory market exclusivity adds an incremental layer of protection in addition to that afforded by existing patents granted in the United States and Europe, and pending in other countries, covering the use of AGI-134 for the treatment of solid cancer tumors. These patents are valid until May 2035, with a possible term extension of up to five additional years. "We are extremely pleased to receive the FDA's Biological Product Designation for AGI-134, our second lead oncology asset. This class Show less Read more
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