UK-based stem cell therapy company ReNeuron (LsE: RENE) has been granted Fast Track designation by the US Food and Drug Administration for its human retinal progenitor cell therapy candidate for retinitis pigmentosa. The news pushed the firm's shares up 4.4% to 5.29 pence.
This follows ReNeuron’s announcement on May 5 that it had received regulatory approval to commence a Phase I/II trial in the USA with its stem cell therapy candidate for the same indication. Retinitis pigmentosa is a group of hereditary diseases of the eye that lead to progressive loss of sight.
The cell therapy candidate for retinitis pigmentosa has already been granted Orphan Drug Designation in both Europe and the USA by the European Commission and the FDA.
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