Latest Biopharmaceuticals News

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.

Paradigm Biopharmaceuticals has secured ethics approval and appointed a CRO to launch its global phase 3 trial for injectable Pentosan Polysulfate Sodium in knee osteoarthritis, while initiating a substantial capital raising program.

Zelira Therapeutics has received a $1.15 million cash refund from the Australian Government’s R&D Tax Incentive Scheme, bolstering its working capital to advance clinical development and business operations.

Opthea has completed the final patient visit in its pivotal COAST Phase 3 trial evaluating sozinibercept combined with aflibercept for wet AMD, with topline results expected early Q2 2025.