DMAC - FDA lifts clinical hold on DiaMedica's Phase 2/3 study for stroke drug

2023-06-21 11:50:49 ET

DiaMedica Therapeutics ( NASDAQ: DMAC ) said the US Food and Drug Administration has lifted a hold on its Phase 2/3 clinical trial for its stroke drug candidate DM199 and that it has agreed to a $37.5M private placement of its stock to help fund the study.

The biotech company intends to restart the trial as soon as possible. The hold was placed by the FDA in July 2022 after the company reported three serious adverse events related to low blood pressure following administration of the drug.

DM199 was granted fast-track status by the FDA in September 2021 for the treatment of acute ischemic stroke in September 2021.

DiaMedica also announced it had entered into agreements for a $37.5M private placement of its shares. Under the agreements, the company will issue approximately 11M shares priced at $3.40 per share, with members of DiaMedica management paying $3.91 per share. The deal is expected to close around June 23.

The company plans to use proceeds from the deal in part to fund the Phase 2/3 clinical study for DM199. It added that it believes the proceeds will be sufficient to fund the study through completion of its interim analysis.

More on DiaMedica:

• DiaMedica Therapeutics reports Q1 results
• DiaMedica Therapeutics GAAP EPS of -$0.52 in-line
• FDA clinical holds pick up amid race for risky, innovative medicines – WSJ

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