Latest Biotechnology News

Cambium Bio has secured FDA confirmation that a single pivotal Phase 3 trial plus confirmatory evidence will suffice for Biologics License Application submission for Elate Ocular, significantly reducing development expenses and accelerating the pathway to market.

BPH Global’s Indonesian arm has entered Stage 2 of its collaboration with Indonesia’s National Research and Innovation Agency to develop fucoidan extraction technology and a powdered supplement prototype, targeting commercialisation within months.

Radiopharm Theranostics (ASX: RAD) has completed enrolment in its Phase 2b RAD 101 brain metastases imaging trial with interim data showing 90% concordance with MRI, while progressing early-stage trials of therapeutic candidates RAD 202, RV-01, and RAD 402. The company reported a $19.2 million cash balance at quarter end, down from $34.5 million, with a net operating cash outflow of $14.9 million driven by milestone-related R&D and staff costs.

Racura Oncology has detailed how its lead drug candidate, (E,E)-bisantrene, silences the cancer-driving MYC gene by stabilising G-quadruplex DNA structures, providing critical preclinical validation ahead of ongoing clinical trials.

Alterity Therapeutics has unveiled fresh Phase 2 data revealing ATH434’s ability to slow functional decline in Multiple System Atrophy patients, measured by the novel MuSyCA scale. This reinforces the drug’s disease-modifying potential ahead of pivotal Phase 3 trials.

Noxopharm reports preclinical data revealing SOF-SKN’s active ingredient remains in skin tissues for about 3.5 days with minimal systemic absorption, supporting less frequent dosing and sustained activity for cutaneous lupus treatment.

Invion Limited is broadening its non-melanoma skin cancer trial to include basal cell carcinoma patients following encouraging safety and efficacy data from squamous cell carcinoma cohorts, targeting the largest skin cancer segment.

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

AdAlta, Oribiotech, and Cell Therapies have inked a Memorandum of Understanding to deploy Oribiotech’s IRO automated cell therapy manufacturing platform in Australia and Asia Pacific, aiming to slash costs and boost production speed for CAR-T therapies.

Patrys has raised A$3.2 million through a share placement to fund its injectable quetiapine program’s Phase 1A clinical trial and FDA pre-IND preparations.

Memphasys Limited has marked a milestone quarter with revenue surpassing A$100,000, driven by repeat orders and multi-year contracts, signalling its transition to a commercially focused biotech business.

Neurizon Therapeutics has secured an additional A$2.7 million through a placement addressing the shortfall from its entitlement offer, lifting total proceeds to approximately A$8.5 million. This fresh capital strengthens the biotech’s balance sheet and provides financial flexibility as it advances its lead ALS drug NUZ-001 through pivotal clinical stages.