Latest Biotechnology News

Cambium Bio has secured ethics approvals in Australia and the US to initiate pivotal Phase 3 trials of Elate Ocular, targeting moderate to severe dry eye disease, with patient dosing expected in October 2025.

Actinogen Medical has locked in up to $13.8 million in non-dilutive funding tied to its R&D tax incentives, bolstering its cash position as it advances a pivotal Alzheimer’s disease clinical trial.

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.

Memphasys Limited has submitted its CE Mark application for the Felix™ sperm separation device, targeting regulatory clearance within 6-12 months to unlock the lucrative European IVF market and accelerate approvals in other key regions.

PYC Therapeutics has announced promising pre-clinical results for its RNA-based drug candidate PYC-002, targeting the genetic root of Phelan-McDermid Syndrome, with clinical trials expected to begin in 2026.

Percheron Therapeutics has licensed HMBD-002, a promising immuno-oncology monoclonal antibody targeting VISTA, from Hummingbird Bioscience, marking a strategic pivot after recent setbacks. The company plans to initiate phase II trials in 2026, aiming to advance this novel cancer therapy toward commercialisation.

Neuren Pharmaceuticals has been granted a US patent for NNZ-2591 to treat Pitt Hopkins syndrome, bolstered by promising Phase 2 clinical trial results and FDA orphan drug status.

Biotron Limited has completed the initial safety phase of its lead Hepatitis B drug in animal studies, paving the way for efficacy testing in two distinct mouse models. This milestone marks a significant step forward in the company’s antiviral drug development program.

Amplia Therapeutics has secured US ethics approval to launch a Phase 2 trial combining its drug narmafotinib with FOLFIRINOX chemotherapy for advanced pancreatic cancer, marking a key step in its clinical development.

INOVIQ Limited has responded to ASX queries defending its announcement that its new CAR-NK-EV treatment killed 88% of breast and lung cancer cells in vitro, confirming compliance with disclosure rules and providing detailed study data.

Invion Limited has announced a fully underwritten entitlement offer of Loyalty Options to raise capital for advancing its cancer clinical trials. The offer, led by Blue Ocean Equities and supported by CEO Prof Thian Chew, invites eligible shareholders to participate in a non-renounceable rights issue.

PYC Therapeutics has gained FDA alignment on the design of its pivotal Phase 2/3 trial for VP-001, a promising treatment for the rare childhood blindness RP11. The regulator accepted the trial’s sham control arm and primary endpoints, setting the stage for a critical next step toward drug approval.