FDA greenlight for Liminal's Ryplazim

The US Food and Drug Administration on Friday approved Ryplazim (plasminogen, human-tvmh) for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia) through Canada-based Liminal BioSciences’ (Nasdaq: LMNL) subsidiary Prometic Biotherapeutics, holder of the biological license application (BLA) for Ryplazim.

With this approval, Ryplazim becomes the first FDA approved therapy for this rare genetic disorder, said Liminal, whose shares rocketed 57% to $6.30 in early pre-market trading today.

"Until now, there were no FDA-approved treatment options for patients with plasminogen deficiency type 1," said Dr Peter Marks, director of FDA's Center for Biologics Evaluation and Research., adding: "Today's approval helps address an unmet medical need for individuals affected by this rare genetic disease."