Latest Regulatory Affairs News

Noxopharm is gearing up for a pivotal pre-IND meeting with the US FDA, enlisting global CRO Novotech to sharpen its regulatory approach for SOF-SKN, a drug targeting autoimmune skin diseases.

Emyria Limited reported $1.2 million in revenue for the March quarter, driven by insurer-funded clinics and strong clinical outcomes in PTSD treatment. The company is advancing its national clinic rollout, including new sites in Victoria and New South Wales, while launching a global partnership program targeting international drug sponsors.

AdAlta has secured A$2.5 million in a strategic placement to push its lead CAR-T therapy BZDS1901 through critical US FDA regulatory steps and establish Australian manufacturing, building on promising clinical responses in advanced mesothelioma.

LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.

Clarity Pharmaceuticals’ Phase II Co-PSMA trial confirms its Cu-SAR-bisPSMA PET imaging detects more than twice the prostate cancer lesions versus standard care, driving patient management changes. Phase III AMPLIFY recruitment closes, manufacturing deals inked, and cash sits near $198 million.

Alterity Therapeutics secures FDA backing on key Phase 3 elements for ATH434 in Multiple System Atrophy, bolstered by fresh Phase 2 data showing slowed disease progression and strategic leadership hires.

Dimerix has completed adult patient recruitment in its Phase 3 ACTION3 trial for DMX-200, with a blinded review confirming the study remains statistically powered to demonstrate treatment efficacy. The company also appointed a new CFO and is negotiating up to US$50 million in non-dilutive funding.

NeuroScientific Biopharmaceuticals reported positive clinical responses in its StemSmart™ Special Access Program for fistulising Crohn’s disease and has initiated manufacturing technology transfer to support Phase 2 trials planned for late 2026.

Algorae Pharmaceuticals strengthened its balance sheet with $5.47 million cash reserves and broadened its commercial footprint through new licensing deals and AI-driven drug validation.

BlinkLab has completed onboarding all clinical sites for its pivotal FDA autism trial, enrolled the first participant, and launched a nationwide autism screening program in Morocco. A recent A$17.7 million capital raise will fund further trials and expansion into ADHD diagnostics.

Syntara Limited has raised A$10 million through a two-tranche placement and share purchase plan, backing its Phase 2b myelofibrosis trial and multiple clinical readouts following positive FDA feedback.

Neurotech International has opened its first Phase 3 clinical site for NTI164 targeting Autism Spectrum Disorder, reported positive 90-day toxicology results, and launched a new Rett syndrome research collaboration.