Latest Clinical Data News

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.

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.

Racura Oncology has launched patient enrolment at its first Korean site for the CPACS Phase 1 trial, aiming to accelerate recruitment and validate RC220’s safety and efficacy in a key oncology market.

Nexsen Limited (ASX:NXN) reported a 30% rise in net loss to $6.55 million for FY26, driven by ongoing investment in its Group B Streptococcus rapid diagnostic and Asia-Pacific growth initiatives following its October 2025 IPO.

PYC Therapeutics strengthened its financial footing with a $600 million capital raise and made notable clinical progress across four RNA therapeutic programs targeting genetic diseases.

OncoSil Medical lifted revenues 44% in FY26 to $1.68 million and trimmed losses by 28% to $10.86 million, buoyed by key regulatory approvals including FDA HDE and Australian TGA listings. The company is poised for commercial launches in the US and Australia, with strong clinical data underpinning its growth.

Entropy Neurodynamics (ASX:ENP) reported a 30% rise in income and a narrower loss for FY26, driven by clinical progress in its IV-infused psilocin therapy TRP-8803, including promising Phase 2 results in Binge Eating Disorder and a new multi-indication basket study.

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

Radiopharm Theranostics has dosed the first patient in the second cohort of its Phase 1/2a trial for RV-01, a radiopharmaceutical targeting B7-H3 expressing solid tumors, marking a key dose escalation milestone.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.

Island Pharmaceuticals has commissioned a second manufacturing run of its antiviral Galidesivir, aiming to stockpile up to 800 treatment courses by late 2026 to support rapid response to the fast-spreading Bundibugyo Ebola outbreak and biodefence efforts.

Recce Pharmaceuticals has secured ethics approval to add an active-controlled arm to its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, enabling head-to-head comparison against existing antibiotics.