Latest Regulatory Submissions News

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

PYC Therapeutics fortified its balance sheet by $600 million and progressed key RNA therapeutic trials in Q1 2026, setting the stage for pivotal clinical data and regulatory submissions.

Cambium Bio has clinched FDA agreement on a streamlined single pivotal Phase 3 trial for Elate Ocular®, cutting development complexity, while bolstering its cash position through a A$2.4 million strategic placement by major shareholder ZYBT.

LTR Pharma has wrapped up recruitment for its SPONTAN Phase II pharmacokinetic study, with interim results expected soon to bolster FDA approval efforts. Meanwhile, US commercial talks for ROXUS advance cautiously under the FDA 503(a) personalised medicine pathway.

Echo IQ has taken a major step in its US expansion by deploying its AI-powered EchoSolv AS software at Mount Sinai Health System, one of America’s leading cardiovascular centres. This marks a key milestone in integrating AI into routine cardiology workflows at scale.

Paradigm Biopharmaceuticals has upsized a $14 million placement and launched a $2 million SPP, boosting its cash runway to around $45 million. This capital injection supports the ongoing Phase 3 trial for knee osteoarthritis, with interim results expected in Q3 2026.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

Kinetiko Energy has unveiled a staged gas production strategy in South Africa, aiming for initial compressed natural gas revenues by Q2/Q3 2027. The company’s new Rolling Cluster Development Strategy promises a risk-managed, capital-efficient pathway from early CNG production to full-field LNG.

Noxopharm reports preclinical data revealing SOF-SKN’s active ingredient remains in skin tissues for about 3.5 days with minimal systemic absorption, supporting less frequent dosing and sustained activity for cutaneous lupus treatment.

Memphasys Limited has marked a milestone quarter with revenue surpassing A$100,000, driven by repeat orders and multi-year contracts, signalling its transition to a commercially focused biotech business.

Orthocell has secured approval for its Remplir™ nerve repair device to be used across 221 U.S. military and veterans hospitals, marking a major step in its U.S. commercial expansion. The approval follows clinical validation in conflict zones, positioning Orthocell to deepen penetration into defence healthcare.

EMVision Medical Devices has ramped up recruitment in its pivotal FDA trial across eight hospitals and is nearing results from multiple pre-hospital studies, all while bolstering its cash position with a $3.8 million R&D tax refund and $6.6 million in grant funding.