PainChek Compiles Information to Address US FDA Questions for De Novo Marketing Clearance Application; Shares Plunge 25%

MT Newswires Live

Jun 05, 2025

PainChek (ASX:PCK) said it is compiling additional information collected from its completed clinical study to address questions from the US Food and Drug Administration, and the submission is expected to be the final step in the firm's US De Novo marketing clearance application, according to a Thursday Australian bourse filing.

The firm said the submission is expected to be the final step in the application and will be submitted before the end of June. It added that there is a commitment by the US FDA for a final decision on De Novo regulatory clearance within 75 days after receiving the submission.

It held a final feedback review meeting with the FDA, focused on addressing the regulator's final questions related to the firm's recent US clinical trial results conducted in New York and Iowa.

The firm also recruited a head of business development for the US market and established integration and reseller agreements with PointClickCare and ElderMark.

The firm's shares fell past 25% in recent trading on Thursday.

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