Latest Biotechnology And Pharmaceuticals News

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.

Patrys has moved its injectable quetiapine program into human testing, while its FY2026 annual report warns the company will need further funding within 12 months. The company ended the year with $3.36 million in cash after raising capital and acquiring the RLS-2202 development program.

Immuron delivered record FY26 sales, a narrower loss and a much stronger cash balance, while shifting clinical development towards commercial partners. The annual report also flags a material weakness in inventory controls and confirms that IMM-529 remains dependent on a future licensing deal.

Paradigm will return the US$2 million drawn from Obsidian earlier this month and cancel the associated convertible notes, without an additional payment. The decision comes as the biotechnology company reviews interim data from its pivotal knee osteoarthritis trial and prepares a separate update on funding and operations.

Paradigm Biopharmaceuticals has secured a voluntary suspension of its ASX securities while it prepares to release interim analysis results from its PARA_OA_012 Phase 3 trial. The announcement gives no indication whether the clinical readout is favourable or unfavourable, with trading potentially resuming on 28 September subject to ASX approval.

Patrys has dosed the first participants in the Phase 1a trial of RLS-2202, moving its intravenous quetiapine formulation into human clinical evaluation. The next test comes in October, when an independent safety committee will decide whether the program can advance to Cohort 2.

Dimerix has secured Mexican composition of matter protection for its Phase 2-ready kidney drug DMX-652 until June 2041. The grant expands the asset’s patent estate ahead of planned clinical testing in acute kidney injury, although it brings no new clinical data or regulatory approval.

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

Paradigm Biopharmaceuticals has drawn the remaining US$2 million available in Tranche 4 of its convertible note facility, adding approximately A$2.8 million to working capital. The funding comes as its fully enrolled Phase 3 knee osteoarthritis trial advances towards interim analysis and top-line results.

CSL Limited’s FY2026 results reveal modest revenue growth offset by a multibillion-dollar statutory loss driven by restructuring and impairments, alongside a maintained dividend and a strategic focus on sustainable growth.

CSL Limited’s interim CEO Gordon Naylor reveals a downgraded FY26 outlook amid slower growth and announces substantial impairments tied to CSL Vifor assets. Leadership changes and transformation efforts aim to restore momentum.