Latest Regulatory Affairs News

Argenica Therapeutics has passed a critical FDA genotoxicity test for its stroke drug ARG-007, advancing its IND application and edging closer to Phase 2b clinical trials in the US and Australia.

BLIS Technologies posted a 16% revenue increase to $14.7 million in FY26, resolving a key intellectual property dispute and expanding strategic partnerships, including an extended Probi AB agreement that now covers pet nutrition.

Patrys has appointed CMAX and Alithia Life Sciences to lead its Phase 1A clinical trial operations for RLS-2202, advancing its injectable quetiapine program toward first-in-human testing in Q3 2026, pending ethics approval.

Alterity Therapeutics has showcased compelling Phase 2 data for ATH434 in Multiple System Atrophy, paving the way for a Phase 3 trial with FDA engagement targeted for mid-2026.

Island Pharmaceuticals has appointed Mark Herzog as Senior Global Health Security Advisor and secured roles in key Medical Countermeasures Coalition groups, boosting its US biodefence engagement ahead of pivotal Galidesivir Animal Rule studies.

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.