Liminal BioSciences refiles for FDA approval of Ryplazim

Canada’s Liminal BioSciences (Nasdaq: LMNL) saw its shares rocket more than 30% to $14.70 in pre-market trading today, as the company revealed that it has filed a resubmission of the Biologics License Application (BLA) for Ryplazim (plasminogen) with the US Food and Drug Administration for the treatment of congenital plasminogen deficiency (C-PLGD), via its US subsidiary Prometic Biotherapeutics.

"The resubmission of this BLA represents a significant milestone for Liminal BioSciences and we believe it has meaningful potential for patients and families affected by congenital plasminogen deficiency," said Kenneth Galbraith, chief executive of Liminal BioSciences, adding: "We look forward to continuing to work with the FDA toward our goal of achieving regulatory approval and making Ryplazim available to patients with this congenital rare disease in the United States."

"C-PLGD is a rare multisystem disorder that can have a profound effect on a patient's health and quality of life. With no approved treatment available, C-PLGD is an area of significant unmet need throughout the world," stated Dr Amy Shapiro, CEO and co-medical director at the Indiana Hemophilia & Thrombosis Center, and principal investigator in the pivotal clinical trial supporting the BLA resubmission.