CIBC World Markets downgraded Prometic Life Sciences (TSX:PLI) to “underperformer” from “neutral” and slashed its price target to 60 cents from $2.15, citing balance sheet risks and a FDA delay of about one year in the potential approval of Ryplazim. The stock closed at 88 cents on March 29.
Last October, the FDA accepted Prometic’s BLA for the treatment of Ryplazim in congenital plasminogen deficiency, with a PDUFA date of April 14, 2018.
“While Prometic’s drug assets have value, the company currently does not have the funding available to move them forward appropriately,” writes analyst Prakash Gowd. “If the company is unable to raise capital, it may be forced to partner or sell these assets from a weak negotiating position.”
The FDA has asked Prometic to make changes to the chemistry, manufacturing and controls (CMC) section of its filing, which require implementation and validation of additional analytical assays and controls in the manufacturing process.
Mr. Gowd said this would necessitate the manufacturing of additional product lots, which Prometic expects to complete in the summer. It plans to provide the FDA with the requested new CMC data in the fourth quarter of 2018. A new PDUFA date will be set after the FDA receives the data, which Mr. Gowd expects will likely be in the first half of 2019.
