Argenica Therapeutics (ASX:AGN) received a full clinical hold letter from the US Food and Drug Administration (FDA) on the reasons for the imposed clinical hold and the information required to lift the hold regarding its investigational new drug application, enable clinical trials of the ARG-007 drug candidate in acute ischaemic stroke in the US, according to a Thursday Australian bourse filing.
The regulator requested additional information to ensure that the proposed trial dosing for a US trial can be achieved safely in humans, and the firm plans to use its phase two acute ischaemic stroke trial safety data, which will be available in September, as part of its response.
The FDA also requested Argenica to conduct three additional in vitro cell culture studies with clinical research organizations to address identified gaps in data. It also asked the firm to include more detail on the phase one data in the investigational brochure.
The firm's shares fell 1% in recent trading on Thursday.
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