Oncology focussed US biotech firm Curis (Nasdaq: CRIS) saw its shares sink 21% to $3.08, after it revealed receipt of written notification from the US Food and Drug Administration that its Phase I study of CUDC-427 has been placed on partial clinical hold following the report of death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing.
Under this partial clinical hold, new patients may not be enrolled in the study until Curis provides the FDA with requested additional data and analysis on patients treated with CUDC-427 and a proposed protocol amendment is submitted to and accepted by the FDA. The company expects to respond to the FDA's requests for additional information and also plans to submit an amendment to the current protocol in a timely manner.
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