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DIMERIX LIMITED (ASX: DXB)

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DXB: Approval received for Paediatric Investigation Plan from EMA

DIMERIX LIMITED

2023-07-05 08:41:00

DXB: Dimerix confirms Phase 3 study design appropriate for China

DIMERIX LIMITED

2023-07-03 08:36:00

DXB: Entitlement offer and Convertible Note to raise $12 million

DIMERIX LIMITED

2023-05-04 09:04:00

DXB: DXB to Receive $2.8m in Prepayment of R&D Tax Incentive

DIMERIX LIMITED

2023-02-17 08:32:00

DXB: Successful Completion of DSMB Review of Phase 3 FSGS Trial

DIMERIX LIMITED

2023-02-09 09:04:00

DXB: FDA Confirms Inclusion of Paediatrics in ACTION3 Study

DIMERIX LIMITED

  1. FDA confirms inclusion of adolescent children (12-17 years old) in ACTION3 global Phase 3 FSGS study is appropriate, increasing the total addressable market for DMX-200 if approved
  2. FSGS is one of the leading causes of kidney failure in children, with 20% of all child nephrotic syndrome cases caused by FSGS1
  3. Dimerix is also in discussion with the European Medicines Agency (EMA) regarding a Paediatric Investigation Plan (PIP), which is a regulatory requirement prior to seeking market approval in Europe, the outcome of which is expected in calendar year 2023

2023-01-12 09:16:00