Shares of Keryx Biopharmaceuticals zoomed up to a 52-week high this morning after the developer announced that the FDA had extended orphan drug status to its late-stage cancer drug KRX-0401. Keryx shares soared 72 percent while its Canadian partner, AEterna Zentaris, saw its stock jump 36 percent.
Keryx in-licensed the North American rights to the multiple myeloma therapy from AEterna, which so far has hung on to the rights for the rest of the world. "The disease (multiple myeloma) based on available clinical data is absolutely the most attractive target market for that drug," said Douglas Loe, an analyst at Versant Partners.
"We are very pleased with perifosine gaining Orphan Drug Designation from the FDA as it would provide extra market exclusivity protection for this compound," says AEterna CEO Juergen Engel. "We now look forward to the start of Keryx's Phase III trial in multiple myeloma by year-end."
- here's the Keryx release
- read the story from Reuters