DMAC - DiaMedica stock slides 17% after hours as FDA maintains clinical hold on DM199 trial

DiaMedica Therapeutics ( NASDAQ: DMAC ) stock slid 17% after hours on Wednesday as the firm said the U.S. FDA is maintaining its clinical hold on its ReMEDy2 phase 2/3 trial evaluating DM199 to treat acute ischemic stroke ( AIS ).

The regulator said it needs additional non-clinical data related to the materials used by a hospital in the IV infusion process to resolve the clinical hold.

The FDA placed a clinical hold on the trial after three serious cases of low blood pressure in stroke patients were reported after receiving an injection of DM199.

In response, DiaMedica ( DMAC ) submitted data to the FDA, which indicated that the cause was likely related to switching the type of IV bag used in the prior ReMEDy 1 trial, where there were no hypotensive episodes, vs. the current ReMEDy 2 trial.

Hypotension is a known response to DM199. DiaMedica ( DMAC ) believes differences in protein binding between the two IV bags used in the trials altered the amount of drug administered.

The FDA requested an additional in-use in vitro stability study of the IV administration of DM199 to rule out any other causes for the hypotensive episodes.

Preparations for these in vitro studies are ongoing.

DiaMedica ( DMAC ) said its cash, cash equivalents and marketable securities as of Sept. 30 were $36.1M, resulting in cash burn of $2.3M for Q3.

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