Latest Regulatory Affairs News

Biotron Limited posted a $1.52 million net loss for FY2026, driven by integration and R&D costs following its Sedarex acquisition, while progressing regulatory and clinical development for its SedRxTM anaesthetic and antiviral pipeline.

Acrux Limited reported a 46% revenue increase to $6.6 million in FY26, driven by US generic product royalties and licensing milestones, while narrowing its net loss by 90%. The company is pivoting towards developing a female testosterone therapy with encouraging Phase II data and active regulatory engagement.

Neurizon Therapeutics has completed enrolment in its pivotal HEALEY ALS Platform Trial ahead of schedule, secured critical manufacturing and funding agreements, and reduced its net loss for FY2026 while preparing for topline results in late Q2 2027.

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.

Prescient Therapeutics cut its net loss by 4.4% to $7 million in FY26 while expanding its PTX-100 Phase 2a trial across three continents and securing key regulatory designations in Europe and the US.

Energy Fuels Inc. reported a transformative 2024 with a major acquisition boosting its heavy mineral sands assets, a uranium production ramp-up at key US mines, and commercial rare earth oxide output from its White Mesa Mill.

Cryosite Limited delivered robust FY26 results with revenue up 18% to $16.7 million and net profit rising 19%, underpinned by a strategic warehouse acquisition that doubled storage capacity and a cool room expansion.

Radiopharm Theranostics is gearing up for a pivotal Phase 3 trial of its brain metastases imaging agent RAD101, following strong Phase 2b results and an upcoming FDA meeting to finalise trial design.

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

Archer Materials has pinpointed a capillary blood collection method that matches venous samples in haemolysis levels, advancing its potassium Biosensor development towards integrated clinical testing.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

Acrux Limited spotlighted its Female Testosterone Metered Dose Transdermal System (MDTS) at the Bioshares Biotech Summit, revealing positive Phase II data and outlining a clear regulatory and commercial roadmap targeting Hypoactive Sexual Desire Disorder (HSDD) in women.