Liminal BioSciences (LMNL +105.1%) expects to re-submit biologics licensing application (BLA) with the FDA for its lead plasma-derived Ryplazim (plasminogen) for congenital plasminogen deficiency, during Q3.
The company also anticipates to commence multiple ascending dose Phase 1 study of its lead small molecule product candidate fezagepras (PBI-4050) in second half of the year.
In March 2018, the company received FDA Complete Response Letter BLA for Ryplazim, and identified the need for number of changes in the Chemistry Manufacturing and Controls section.
In October 2018, announced positive feedback from FDA Type-C meeting on Ryplazim BLA.
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood, and is vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
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