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Biopharmaceutical Firm Receives FDA Priority Review and PDUFA Date
Research Report

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Neil Maruoka, an analyst with Canaccord Genuity, provided an update on this biotech's progress through the regulatory approval process for one of its therapeutics.

An Oct. 13 research note indicated the U.S. Food and Drug Administration (FDA) accepted ProMetic Life Sciences Inc.'s (PLI:TSX) biologics license application for Ryplazim (plasminogen) and set a PDUFA date of April 14, 2018.

"We view this to be an important milestone for the company (removing a significant overhang for the stock), as it provides certainty in a process that has been anything but," noted Neil Maruoka, an analyst with Canaccord Genuity. "With an FDA decision date now in hand, we believe that ProMetic now has a clearer pathway to a potential approval of its first major therapeutic."

Maruoka expressed optimism regarding ProMetic's biologic. "We believe the drug could address an unmet clinical need, and we see a strong likelihood that Ryplazim will be approved next year, providing a significant potential catalyst for the stock." In its favor are "strong clinical data, orphan drug status, an accelerated approval pathway and a rare pediatric disease designation."

The FDA also afforded ProMetric "a priority review (and an 'official' six-month review period), and we believe the company is therefore eligible to receive a priority review voucher (PRV) if Ryplazim is approved," Maruoka wrote. "We believe this would be a valuable asset for ProMetic." Such a voucher decreases the review period for a drug to six months from ten. It is "transferable, and PRVs have been sold in the past for over $100M."

In the research report, Maruoka identified cash burn as "the key risk for ProMetic," which he would like to see reduced ahead of the FDA ruling next year.

Along with the anticipated FDA approval of Ryplazim, other short-term catalysts for the company are "more data from PBI-4050" and "the initiation of clinical studies for PBI-4050 in idiopathic pulmonary fibrosis and diabetic kidney disease," the analyst noted.

On ProMetic, Canaccord Genuity has a CA$4.25 per share price target, which, Maruoka explained, "implies a 172% annualized return and continues to support our Buy recommendation." The biotech's stock is currently trading at around CA$1.59 per share.

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