BioLineRx Receives Orphan Drug Designation From the FDA for its Lead Therapeutic Candidate BL-8040 for the Treatment of Pancreatic Cancer
BioLineRx Ltd. - American Depositary Shares (BLRX)
Last biolinerx ltd. - american depositary shares earnings: 5/14 07:00 am
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Source: PR Newswire
TEL AVIV, Israel, Feb. 4, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead oncology candidate, BL-8040, for the treatment of pancreatic cancer. "Orphan Drug Designation in pancreatic cancer is a very important milestone in the development plan of BL-8040, and joins previously approved orphan designations by the FDA for BL-8040 in AML and stem-cell mobilization," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Despite advances in the treatment of various cancers with immune checkpoint inhibitors, pancreatic cancer is refractory to these treatment options, and remains an area of significant unmet medical need. We have previously reported encouraging clinical data supporting the potential of BL-8040 as part of an immunotherapy combination treatment in pancreatic cancer, and we look f
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BLRX
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- 4/17/24 - Form 6-K
- 4/10/24 - Form 6-K
- 4/1/24 - Form 6-K
- BLRX's page on the SEC website