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
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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
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News
- BioLineRx Announces Poster Presentation on Economic Model Data for APHEXDA® (motixafortide) as part of CD34+ Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma at ISPOR 2024PR Newswire
- BioLineRx Ltd. (NASDAQ: BLRX) was upgraded by analysts at StockNews.com to a "sell" rating.MarketBeat
- BioLineRx Announces Poster Presentation on Apheresis Center Efficiency and CXCR4 Antagonists including APHEXDA® (motixafortide) in Patients with Multiple Myeloma at the ASFA 2024 Annual Meeting [Yahoo! Finance]Yahoo! Finance
- BioLineRx Announces Poster Presentation on Apheresis Center Efficiency and CXCR4 Antagonists including APHEXDA® (motixafortide) in Patients with Multiple Myeloma at the ASFA 2024 Annual MeetingPR Newswire
- BioLineRx Ltd. (NASDAQ: BLRX) was upgraded by analysts at StockNews.com to a "sell" rating.MarketBeat
BLRX
Sec Filings
- 5/6/24 - Form 6-K
- 4/17/24 - Form 6-K
- 4/10/24 - Form 6-K
- BLRX's page on the SEC website