Latest Clinical Development News

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.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

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.

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.

TrivarX has made Stabl-Im its central development bet, but the ASX-listed health technology company also reported an $8.76 million FY2026 loss and an auditor-flagged material uncertainty over its ability to continue without further funding. The planned Phase 1 study remains subject to regulatory, ethics and operational clearances.

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.

Cleo Diagnostics has begun developing a multi-biomarker blood test for ovarian cancer screening in asymptomatic women, targeting a stated $150 billion global market. The prototype program will run alongside the company’s pre-surgical test, with initial proof-of-concept data expected early next quarter.

TrivarX has moved Stabl-Im closer to human testing, with pre-clinical studies underway, investigational product preparation progressing and clinical site selection now open. The indicative plan targets first participant enrolment in Q1 2027, but key technical and ethics steps remain outstanding.

Dimerix has drawn A$17 million from a non-dilutive facility, giving the biotech funding it says is sufficient to complete the ACTION3 Phase 3 trial of DMX-200 and continue developing DMX-652. A further A$17 million remains available, although repayment depends partly on future licensing income, milestones or capital-market access.

Booster Innovation Fund has invested $200,000 in TheiaNova, a University of Auckland spinout developing a self-administered eye drop for keratoconus. The seed-stage bet accounts for 0.76% of BIF’s portfolio, keeping the exposure modest while adding an early biotechnology asset.