Dimerix's Drug Candidate Approval by FDA Unrelated to US Peer's New Drug Application Approval Date

MT Newswires Live
01/14

The US Food and Drug Administration (FDA) approval of Dimerix's (ASX:DXB) drug candidate DMX-200 is not to be impacted by the FDA's extension of the approval decision date for US-listed Travere Therapeutics' supplemental New Drug Application, according to a Wednesday note by Euroz Hartleys.

The decision is unrelated to the FDA's prior feedback to the company that supports approval of DMX-200, in the ACTION3 trial for patients with Focal Segmental Glomerulosclerosis, Euroz said.

In December 2025, the FDA requested further information and documentation, which the company said it expected to provide shortly.

Euroz continues to believe that the FDA approval for Travere's application will have an outcome that ranges from neutral to positive for the company.

It maintained its speculative buy rating on the company and its AU$1.68 price target.

Shares of the company rose 3% at market close.

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