- Medexus Pharmaceuticals (TSX:MDP) announced on Monday (September 19) that it has received a second notice of incomplete response regarding an NDA application resubmission for treosulfan
- The FDA requires additional supporting information in order to complete the resubmission
- The company said it will provide an update once it knows if the resubmission has been accepted
- Shares of Medexus are down 27.84 per cent, trading at C$1.40 at 11:53 a.m. EDT
Medexus Pharmaceuticals (TSX:MDP) announced that medac received an update to its NDA application resubmission.
According to the company medac, the licensor of Medexus’ commercialization rights to treosulfan, received a second notice of incomplete response from the US Food and Drug Administration (FDA) for treosulfan.
The regulatory agency said it requires additional supporting information to complete the resubmission but doesn’t require new clinical data submission.
Medexus said it will provide an update once it knows if the resubmission has been accepted.
“While we recognize that the FDA’s response timeline has proven longer than anticipated, we are encouraged to see that the Agency remains engaged with medac to find a path towards resubmission,” Ken d’Entremont, CEO of Medexus, said in a press release. “We continue to seek opportunities to collaborate with medac to the extent permitted by our license agreement in order to support medac in satisfying the FDA’s requests and in upholding their responsibility for treosulfan regulatory matters.”
He added that the company believes treosulfan would be a game changer for US patients the way it has in the US and Canada and remains optimistic about treosulfan’s approval in the US.
Treosulfan is part of a preparative regimen for allogeneic hematopoietic stem cell transplantation. It can be used in combination with fludarabine for commercialization in the US and Canada.
Health Canada approved treosulfan in June 2021.
Shares of Medexus are down 27.84 per cent, trading at C$1.40 at 11:53 a.m. EDT.