Asia
Kringle Pharma Submits IND Application for Spinal Cord Injury Drug to U.S. FDA; Shares Jump 7%
Kringle Pharma (TYO:4884) submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a phase three clinical trial in the U.S. for acute spinal cord injury drug oremepermin alfa.The proprietary recombinant human HGF therapeutic, Oremepermin alfa, completed phase one/two and phase three trials in Japan for acute spinal cord injury, the late-stage clinical biopharmaceutical company said in a Thursday filing with the Japan bourse.The company is carrying out an additional Phase 3 trial to support a future regulatory submission, while the drug has secured orphan drug designation for acute SCI in Japan, the U.S. and Europe, it said.Shares of Kringle Pharma added nearly 7% in recent trade.
TYO:4884
