Latest Biotechnology News

Radiopharm says the FDA has provided a clear framework for the pivotal development of RAD101, its investigational brain metastases imaging agent. The company is preparing for Phase 3 while awaiting formal meeting minutes that could still refine the trial design and regulatory requirements.

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

CSL has secured an exclusive agreement to co-develop and co-promote Alentis Therapeutics’ investigational drug lixudebart, committing US$355 million upfront and funding a multi-trial development programme. The antibody remains unapproved, with its commercial potential dependent on results from ongoing and planned clinical studies.

Island Pharmaceuticals has begun GMP production of Galidesivir, with the first 5kg batch targeted for an investigational Ebola treatment program in Uganda. A second batch is intended to support a pivotal Marburg animal study under the FDA’s Animal Rule pathway.

Chimeric Therapeutics remains suspended from ASX trading after failing to lodge its FY2026 financial statements, with the company reporting an approximate $7.7 million net asset deficiency and unresolved creditor negotiations. Potential recapitalisation interest has emerged, but no binding funding or settlement agreement has been reached.

ASX has suspended 15 listed companies from quotation after they failed to lodge required periodic reports by their deadlines. Trading may resume quickly if the outstanding reports are lodged, but the announcement gives no detail on the cause or length of each delay.

Radiopharm Theranostics reported a A$56.3 million comprehensive loss for fiscal 2026, with operating cash outflows rising to A$52.8 million and cash falling to A$4.1 million. The company says further funding is required, while auditors flag a material uncertainty over its ability to continue as a going concern.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Imagion Biosystems has secured central ethics approval for its US Phase 1b/2 trial of the MagSense HER2 imaging agent, removing a key requirement before recruitment can begin. Site activation is now underway, but no patient has yet been enrolled and the announcement provides no clinical data.

Paradigm Biopharmaceuticals has entered voluntary administration after its pivotal Phase 3 trial produced an interim efficacy result below the threshold required for continuation. The company’s securities will remain suspended while administrators assess its viability, liabilities and possible restructuring options.

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

Ocean Sciences delivered a sharp increase in seaweed revenue during FY2026, but the audited report also records a A$1.612 million continuing-operations loss, A$2.319 million operating cash outflow and material uncertainty over its ability to continue as a going concern. The renamed ASX-listed group is now seeking up to A$3 million while building out its Indonesian platform.