Shares of Prometic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF) are gaining ground in early Tuesday trading on news that the U.S. Food and Drug Administration has awarded a Rare Pediatric Disease designation for Ryplazimä.
Prometic is developing the plasminogen replacement therapy for the treatment of patients with congenital plasminogen deficiency, a condition characterized by inflamed growths on the mucous membranes, the moist tissue that line body openings such as the mouth, nose and eyes.
The condition most frequently affects the conjunctiva, the mucous membranes that line the eyelids and protect the sclera, or white part of the eye. When growths occur in the windpipe, the condition can be life-threatening, especially in children.
The latest FDA designation joins the Orphan Drug and Fast Track designations already granted to Ryplazimä. These designations are all meant to help expedite development of new therapies for areas of unmet medical need and provide a series of benefits, such as priority review and extended exclusivity if the treatment makes it to market.
As the name implies, a Rare Pediatric Disease is for serious or life-threatening diseases and conditions for people under the age 18.
Headquartered in Laval, Quebec, Prometic has research facilities in Canada, the U.S. and United Kingdom, as well as manufacturing facilities in the U.K.
More broadly, Prometic has completed its pivotal Phase 2/3 clinical trial in patients with plasminogen deficiency, successfully meeting its primary and secondary endpoints with the intravenous plasminogen treatment by increasing blood plasma concentrations and completely healing any active lesions.
The IV-therapy was shown to be very safe and well tolerated.
Toronto-listed shares of PLI had been tumbling since hitting $2.64 on February 16, including touching a 52-week low of $1.12 last Thursday. On today's news, though, shares have shot ahead 24.2% in morning action to $1.49.
