01:37 PM EST, 01/22/2025 (MT Newswires) -- Medexus Pharmaceuticals ( MEDXF ) up near 30% on last look, says the Food and Drug Administration has approved treosulfan, or Grafapex, as an injectable, for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year and older with acute myeloid leukemia or myelodysplastic syndrome.

Grafapex, designated an orphan drug, will benefit from up to seven-and-a-half years of regulatory exclusivity in the FDA-approved indication. Medexus holds exclusive commercial rights to Grafapex in the United States, which it licensed from German company medac.

The company is targeting a commercial launch in the first half of this year., and expects that annual product-level revenue may exceed US$100 million within five years after commercial launch.

Medexus expects to pay a $15 million milestone payment to Medac. It will also repay a US$2.5 million credit that it received from medac in September 2021.

The company also provided preliminary estimates for its fiscal third quarter. It expects revenue of between $29.5 million and $30.5 million, a 17% increase.

Medexus was last seen up $1.18 to $5.17 on the Toronto Stock Exchange.

Price: 4.86, Change: +0.87, Percent Change: +21.80