Prokidney receives allowance from the uk medicines and healthcare products regulatory agency (mhra) for proact 1 (regen-006) and ema scientific advice on phase 3 protocols of react for diabetic chronic kidney disease

Winston-salem, n.c., nov. 03, 2022 (globe newswire) -- prokidney corp. (nasdaq: prok) (“prokidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (ckd), today announced the allowance of the proact 1 (regen-006) phase 3 study protocol for its investigational candidate react® by the united kingdom's (uk) mhra. this follows submission of a clinical trial application for the proact 1 phase 3 study protocol previously allowed by the food & drug administration (fda) in the united states (us), where recruitment is actively underway, and now allows prokidney to begin patient recruitment at clinical trial sites in the uk. in a related regulatory development, prokidney also received favorable scientific advice from the european medicines agency (ema) on the adequacy of its phase 3 development program, consisting of proact 1 and proact 2, to support an eventual marketing authorization application (maa).
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