Latest Clinical Studies News

Noxopharm says the FDA has supported its proposed Phase II design and chemical manufacturing strategy for SOF-SKN, its topical treatment candidate for cutaneous lupus erythematosus. The feedback improves regulatory clarity, but the trial remains targeted for the first half of calendar 2028 and is subject to further studies and regulatory requirements.

ReNerve’s October AGM presentation points to sharply higher sales, a growing US distribution network and a broader nerve repair pipeline. The company is also progressing a 240-patient NervAlign clinical study while relying on a $5 million RiverFort funding facility to support expansion.

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

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.

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.

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.

Nutritional Growth Solutions has completed its acquisition of Sprout Organic, installing founder Selasi Berdie as CEO and reshaping the group around infant, toddler and children’s nutrition. The deal lifts shares on issue to 964 million, while management targets A$870,000 in annualised savings.

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 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.

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

Rhythm Biosciences has completed the first phase of transferring its ColoSTAT blood test to an independent NHS laboratory in England. The milestone supports its international laboratory-partnership strategy, but clinical validation and NHS adoption remain ahead.

Epiminder has enrolled the 75th patient in its DETECT study, meeting its September target as the US site network expands to 21 centres. The company expects to reach 100 enrolments in November and remains focused on completing the 210-patient study by the end of the first half of calendar 2027.