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Kringle Pharma’s KP-100IT Receives U.S. FDA Orphan Drug Designation for Spinal Cord Injury

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Kringle Pharma’s KP-100IT Receives U.S. FDA Orphan Drug Designation for Spinal Cord Injury

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Kringle Pharma, Inc. ( (JP:4884) ) just unveiled an announcement.

Kringle Pharma, Inc. announced that the U.S. FDA has granted orphan drug designation to KP-100IT, a recombinant human hepatocyte growth factor, for treating acute spinal cord injury. This designation provides Kringle Pharma with seven years of market exclusivity in the U.S. upon FDA approval, along with various development incentives. The designation is expected to accelerate drug development in the U.S. and enhance Kringle’s global expansion efforts, potentially impacting partnership discussions with global pharmaceutical companies.

More about Kringle Pharma, Inc.

Kringle Pharma, Inc., established in December 2001 and based in Osaka, Japan, is a late clinical-stage biopharmaceutical company focused on developing novel biologics based on hepatocyte growth factor (HGF). The company is advancing its late-stage pipeline, including oremepermine alfa for acute spinal cord injury and vocal cord scarring, both in Phase 3 clinical trials. Kringle Pharma aims to contribute to global healthcare by developing HGF drugs for patients with incurable diseases.

Average Trading Volume: 78,409

Technical Sentiment Signal: Buy

Current Market Cap: Yen5.87B

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