Shares in Minneapolis-based DiaMedica Therapeutics (Nasdaq: DMAC), a biopharma focused on developing novel treatments for neurological disorders and kidney diseases, were down by a third in pre-market trading on Thursday.
This follows the news that the US Food and Drug Administration (FDA) has placed a clinical hold on the Phase II/III ReMEDy2 trial studying the use of the company’s product candidate, DM199, to treat acute ischemic stroke (AIS) patients.
"We remain confident about the future potential of DM199 and are committed to refining the dosing procedures and methods that will further enhance patient safety"This clinical hold was initiated following DiaMedica’s pause in patient enrollment and submission of three serious adverse event reports to the FDA related to clinically significant, transient hypotension occurring shortly after initiation of the intravenous (IV) dose of DM199.
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