Latest Regulatory Affairs News

Mesoblast Limited reports a 69% jump in net revenues from its pioneering cell therapy Ryoncil in Q1 FY2026, propelled by expanded physician adoption and new reimbursement pathways. The company also secures convertible note funding and plans pivotal adult trials.

Actinogen Medical has fast-tracked recruitment in its XanaMIA Alzheimer’s trial, closing pTau biomarker screening early and increasing participant numbers, aiming for final results by mid Q4 2026.

Biotron Limited is set to acquire Sedarex Limited, gaining global patents for SedRx, a next-generation general anaesthetic, supported by a $2.5 million capital raising to fund regulatory and development milestones.

Highfield Resources has locked in A$10 million through convertible notes from existing investors to tackle a key permit issue and push forward its flagship Muga Potash Project in Spain.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

Prescient Therapeutics has bolstered its cash reserves to $12.3 million following a $9.8 million capital raise, while progressing its PTX-100 cancer therapy through global Phase 2 trials with encouraging early lymphoma results.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent, progressing toward a Phase 2 clinical trial with strong collaborations and a recent AU$3.5 million capital raise.

Echo IQ’s application for a Category III CPT code was declined by the AMA, but the company is exploring reconsideration and new AI-specific coding frameworks to advance US reimbursement.

Paradigm Biopharmaceuticals has dosed participants in its pivotal Phase 3 trial for knee osteoarthritis across the US and Australia, progressing steadily towards a mid-2026 interim analysis.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

CurveBeam AI Limited has secured A$6.5 million in new capital to fuel global growth of its HiRise™ weight-bearing CT scanner, deepen its partnership with orthopaedic giant Stryker, and advance a potential strategic deal in China.