Canaccord Genuity analyst Neil Maruoka likes the recent developments at ProMetic Life Sciences (ProMetic Life Sciences Stock Quote, Chart, News: TSX:PLI).
This morning, ProMetic announced that Ryplazim, its plasminogen replacement therapy for the treatment of patients with congenital plasminogen deficiency, had received a Pediatric Disease designation.
“We are pleased that Ryplazim has received this pediatric designation from the FDA. In addition to Ryplazim’s orphan drug status, this designation represents another validation of the approach we have taken regarding our plasminogen’s clinical program,” said CEO Pierre Laurin. “The pediatric designation also provides an important incentive for ProMetic to continue developing therapies addressing unmet medical needs for children with rare diseases. We look forward to continue to work closely with the FDA to bringing this innovative therapy to patients suffering from plasminogen deficiency.”
Maruoka today explained the significance of this news, and adds that he thinks Ryplazim still has a good chance of approval, noting that the Ryplazim BLA issupported by strong clinical data, Orphan Drug status, an Accelerated Approval pathway, and now a Pediatric Disease designation
“A Priority Review voucher reduces the review time for any drug from 10 months to 6 months; it is transferable and they have been sold in the past for over $100 million,” the analyst notes. “We believe this would be a valuable asset for ProMetic, with the potential to help alleviate the financing overhang. Nonetheless, we believe that the process of monetizing a Priority Review voucher could take some time, and we therefore remain cautious of ProMetic’s cash burn.”
In a research update to clients today, Maruoka maintained his “Buy” rating and one-year price target of $4.25 on ProMetic, implying a return of 254.2 per cent.