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The US FDA has granted Fast Track Designation to Graviton BioScience‘s GV101, an oral, selective ROCK2 inhibitor, for the treatment of Friedreich’s ataxia (FA), following the recent clearance of its IND
Graviton is initiating a 12wk., randomized, PBO-controlled, dose-finding P-II trial of GV101 in pts with FA, with first enrollment at US sites expected in Q4’26 and globally shortly thereafter
GV101 has been shown in preclinical studies to increase frataxin mRNA & protein levels; >500 participants have received GV101 in clinical studies for up to 24wks., with extension studies exceeding 1yr.
Ref: PR Newswire | Image: Graviton BioScience | Press Release
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The post Graviton BioScience Receives the US FDA’s Fast Track Designation for GV101 to Treat Friedreich’s Ataxia appeared first on PharmaShots.