News of NDA Resubmission Is Sending Shares of this Pharma Firm ...

News of NDA Resubmission Is Sending Shares of this Pharma Firm Higher

News of NDA Resubmission Is Sending Shares of this Pharma Firm Higher By: Tomas Ronolski - News

Thursday, June 6, 2024

In the United States, a new drug application, or NDA, is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. And news that the FDA has accepted this firm’s resubmission is sending shares higher in Thursday trade.

Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) announced in a press release today that it was informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the U.S. Food and Drug Administration has accepted for review medac's April 2024 resubmission of the New Drug Application for treosulfan. The FDA review is expected to be completed by October 30, 2024. 

The treosulfan NDA seeks approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients. Medac's resubmission provided additional information that had previously been requested by the FDA relating to the pivotal phase 3 clinical trial of treosulfan conducted by medac.

According to the release, Medexus successfully launched treosulfan in Canada under the brand name Trecondyv® in September 2021 and has gained valuable experience commercializing the product in that market since then. This success supports Medexus's optimism regarding treosulfan's potential positive impact in the U.S. market if and when approved.

Canadian shares were trading up over 12 percent in late morning trade; U.S. shares were up over 11 percent.


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