Latest Biopharmaceuticals News

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

NeuroScientific Biopharmaceuticals (ASX:NSB) has locked in a key FDA Pre-IND meeting for late August, advancing its Phase 2 trial plans for StemSmart™ targeting refractory Crohn’s disease in the US and Australia.

Dimerix CEO Dr Nina Webster detailed the company’s geographic and product diversification at the Bioshares Summit, spotlighting the commercial potential of DMX-200 and the newly acquired Phase 2 asset DMX-652 targeting acute kidney injury.

Neurotech International has secured $4.5 million through a share placement to fund its pivotal Phase III clinical trial of NTI164 for Autism Spectrum Disorder, aiming to reach topline data readout.

Zelira Therapeutics has raised nearly US$33 million into its HOPE® 1 special purpose vehicle, valuing the SPV at about US$66 million post-money. The funds will advance FDA regulatory submissions and Phase 1 clinical trials for its autism-targeting cannabinoid drug.

NeuroScientific Biopharmaceuticals achieved an 80% clinical response rate in fistulising Crohn’s disease patients treated under the TGA Special Access Scheme, advancing plans for Phase 2 trials and manufacturing scale-up.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.

Invex Therapeutics has broadened its preclinical Alzheimer's program with Tessara Therapeutics, while its cash reserves dipped to $4.02 million in Q4 FY26 amid increased research and administrative costs.

CLINUVEL Pharmaceuticals is relocating its corporate headquarters to the United States and reducing its global workforce by up to 20%, realigning its operations to focus solely on the US pharmaceutical market and unlock greater capital access.

Radiopharm Theranostics reported robust Phase 2b results for RAD101 in brain metastases imaging, hitting 93% concordance with MRI and setting the stage for a U.S. Phase 3 trial. Meanwhile, its Phase 1 trial of RAD204 showed durable partial responses and good tolerability in advanced solid tumors.

Paradigm Biopharmaceuticals has strengthened its balance sheet with a combined $5.75 million cash inflow from Australian Government R&D tax incentives, supporting its pivotal Phase 3 osteoarthritis trial and regulatory efforts.

Telix Pharmaceuticals reported a 21% year-on-year revenue jump to US$247 million in Q2 2026, buoyed by strong Precision Medicine sales and a new Regeneron partnership. The company also secured FDA alignment on a pivotal prostate cancer trial and expanded its manufacturing footprint.