8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and reduction in lesion size.
Liminal BioSciences today announced that the Company, through its U.S. subsidiary Prometic Biotherapeutics, has filed a resubmission of the biologics license application for Ryplazim (plasminogen) with the U.S. FDA for the treatment of congenital plasminogen deficiency.
In 2017 the Company received a complete response letter in response to a BLA submission for Ryplazim. The Company believes that the resubmission addresses the deficiencies outlined in the letter, which were related to certain manufacturing procedures.