Latest Biopharmaceutical News

Paradigm Biopharmaceuticals has reached key milestones in its global Phase 3 trial for knee osteoarthritis, activating its first Australian clinical site and enrolling the first patient. With multiple sites in Australia and the US preparing for recruitment, the trial is advancing steadily toward critical data readouts.

Radiopharm Theranostics has unveiled encouraging preclinical results for its Lu177-B7H3 monoclonal antibody, RV01, paving the way for a mid-2025 Investigational New Drug submission and a Phase 1 trial later that year.

Dimerix has activated the first clinical trial site in Japan for its pivotal Phase 3 ACTION3 study targeting FSGS, triggering a significant milestone payment from its Japanese partner FUSO Pharmaceutical.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.

Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.

Dimerix has received a US$30 million upfront payment from Amicus Therapeutics for exclusive US rights to DMX-200, a promising kidney disease therapy. The deal positions Dimerix for up to US$560 million in further milestones plus royalties, underpinning its global licensing strategy.

Dimerix Limited has announced a US licensing transaction for its Phase 3 asset DMX-200 targeting FSGS, alongside progress updates on its clinical trial. The move underscores the company’s push to address a rare kidney disease with no approved therapies.

Dimerix has inked an exclusive US licensing agreement with Amicus Therapeutics for DMX-200, a promising Phase 3 treatment for FSGS, unlocking $30 million upfront and up to $560 million in milestones.

Dimerix Limited advances its Phase 3 kidney disease trial with FDA acceptance of proteinuria as a primary endpoint and clinches a lucrative licensing agreement in Japan worth up to AU$107 million plus royalties.

Opthea Limited has discontinued its wet AMD development program following Phase III trial failures, slashing its workforce by 65% amid ongoing financial uncertainty and negotiations with investors.

Imugene Limited reports encouraging Phase 1b results for azer-cel in lymphoma, secures FDA Fast Track status, and strengthens patent portfolio while raising A$20 million to fuel ongoing immuno-oncology programs.

Tryptamine Therapeutics has secured a landmark agreement with Swinburne University to initiate the first clinical trial of its IV-infused psilocin formulation TRP-8803 for Binge Eating Disorder, aiming to build on promising Phase 2a data.