BioLineRx gains FDA Biological Product designation for I-O compound AGI-134
The US Food and Drug Administration has granted the Biological Product Designation for Israel-based biotech BioLineRx’ (TASE: BLRX) novel immunotherapy compound AGI-134, which it gained rights to along with its acquisition of Agalimmune, a private UK-based company with an innovative, last year.
BioLineRx saw its shares jump almost 13% in premarket trading after the announcement yesterday, and rose another 3.86% to 258.00 shekels this morning.
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.
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