A Health Canada request for more information means a delay is a slight negative for Knight Therapeutics (Knight Therapeutics Stock Quote, Chart, News: TSX:GUD), but Laurentian Bank Securities analyst Joseph Walewicz says the drug may still meet his timeline.
This morning, Knight Therapeutics announced that it had received a notice of deficiency (NOD) for its ATryn new drug submission. Health Canada, said the company, has requested additional technical information on the drug in order to complete its assessment of the product.
“Such requests are not unusual during the regulatory review,” said CEO Jonathan Ross Goodman. “I am confident that we can work through Health Canada’s questions towards approval. ATryn is approved for sale in both the United States and Europe, and touches the lives of patients with hereditary antithrombin deficiency. We look forward to working with Health Canada to bring this important treatment option to Canadian patients.”
Walewicz says the delay is a “slight negative” that doesn’t change his forecast on the stock.
“(Knight Therapeutics) announced that it has received a Notice of Deficiency from Health Canada in relation to its Canadian application for approval of ATryn,” says the analyst. “GUD mentioned “additional technical information”, which we would interpret as manufacturing-related and should result in a minor delay. We note that ATryn is already approved in the E.U. and the U.S. so we expect it will ultimately receive Health Canada approval – we do not have any ATryn revenues until Q2/2017, so this delay still remains within our forecast. ATryn is recombinant human antithrombin and, if approved, will be used to prevent thromboembolic events (i.e. clot formation) in patients that are antithrombin deficient.”
In a research update to clients today, Walewicz maintained his “Hold” rating and one-year price target of $8.50 on Knight Therapeutics.