Latest Regulatory Affairs News

Amplia Therapeutics has launched a Phase 2b trial testing a new daily dosing regimen of narmafotinib combined with chemotherapy in advanced pancreatic cancer, aiming to accelerate progress towards a pivotal Phase 3 study.

Diamond Infraco, backed by IFM Global Infrastructure Fund, has lodged a Takeovers Panel application alleging material disclosure deficiencies in Atlas Arteria's takeover bid documents, centering on governance rights tied to the Chicago Skyway asset.

EBR Systems accelerated its U.S. commercial rollout of the WiSE CRT System in Q1 2026 with implant volumes more than doubling and revenue hitting US$2.4 million. The company also secured a key regulatory milestone in Australia with TGA Priority Review, yet losses deepened and cash burn intensified, raising fresh questions about its funding runway.

EMVision is broadening its emu™ Pivotal Trial to include acute ischaemia detection, aiming to accelerate FDA clearance and enhance the brain scanner's clinical impact. Recruitment has passed 125 patients across US and Australian sites, with full enrolment expected by early 2027.

Neuren Pharmaceuticals saw a 20% jump in Q1 2026 DAYBUE net sales to US$101 million, with royalties up 23%. The Japan trofinetide trial has been fast-tracked, and the new powder formulation DAYBUE STIX gains early traction.

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.