Latest Regulatory Affairs News

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

A2MP Investments has issued a third supplementary bidder's statement disputing the valuation and assumptions underpinning Canyon Resources' takeover response, highlighting persistent funding uncertainties and project execution risks. The bidder insists its offer remains the sole liquidity option for shareholders ahead of the September 21 deadline.

Actinogen Medical has locked in full underwriting for nearly 127 million unlisted options, guaranteeing $4.77 million in fresh funding as it approaches pivotal Alzheimer’s trial results due in November.

The Star Entertainment Group narrowed its net loss to $307 million in FY26, boosted by refinancing, operational improvements, and a joint venture exit, while navigating ongoing regulatory scrutiny and remediation efforts.

Avecho has resumed enrolment for the last stage of its pivotal Phase III trial of a TPM®-enhanced CBD capsule for insomnia, following a unanimous Data Monitoring Board recommendation to continue without expanding the sample size.

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.

CurveBeam AI’s FY2026 results show a 28% revenue decline and a 12% increase in net loss, while advancing its China commercialisation and robotic surgery integration strategies. The company also announced a $6-7 million capital raise post-year-end.

Ceretas Limited posted a $1.63 million net loss for FY26 on $1.28 million revenue from government grants, advancing its clinical-stage Alzheimer’s ultrasound platform. The company completed an $8 million IPO in July to fund pivotal trials and device development.

Alterity Therapeutics posted a 285% jump in revenue to A$1.72 million but also a 93% rise in net loss to A$23.4 million for FY2026. The company secured FDA alignment on a single pivotal Phase 3 trial for ATH434 in Multiple System Atrophy, setting the stage for trial start by year-end.

SomnoMed reported a 3% revenue rise to $114.5 million and a 19% EBITDA increase to $10.9 million in FY26, navigating European market headwinds and a CEO transition while launching its Virtus device targeting sleep apnea with bruxism.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.