DMAC - DiaMedica rises 6% on successful Type B meeting with FDA for DM199 study in acute ischemic stroke

DiaMedica Therapeutics (DMAC) has recently received responses from the FDA following a Type B Pre-IND meeting request, submitted in October 2020 regarding the development plan for its product candidate, DM199, in the treatment of acute ischemic stroke ((AIS)).The Agency agreed with DiaMedica’s proposals regarding plans for an adaptive trial design with a primary endpoint based upon the modified Rankin Scale (mRS) at day 90 and acknowledged that, provided the study results qualify, a single trial may support a Biologics License Application ((BLA)) submission. Secondary endpoints are anticipated to include stroke recurrence and standard stroke measures.The FDA has not recommend any additional studies in preparation for an IND.The company plans to submit an investigational new drug ((IND)) application to the FDA for a Phase 2/3 study in Q1 2021 and expects to enroll ~300 to 350 subjects age 18 and over.Ischemic stroke is characterized by the sudden loss of blood circulation to an

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DiaMedica rises 6% on successful Type B meeting with FDA for DM199 study in acute ischemic stroke