regulatory
confidence high
sentiment positive
materiality 0.65
FDA grants Orphan Drug Designation for Klotho's KLTO-202 to treat ALS
Greenland Mines Ltd
- FDA granted Orphan Drug Designation for KLTO-202 (s-KL-AAV.myo) for ALS.
- Designation provides tax credits for clinical trials, GDUFA fee waiver, and 7-year U.S. market exclusivity.
- Company completed proof-of-concept in two animal ALS models; initiating manufacturing and FDA/EMA meetings.
- KLTO-202 is a gene therapy using a muscle-specific desmin promoter to deliver secreted-Klotho protein.
item 7.01item 9.01