Latest Regulatory News

Cambium Bio has secured FDA confirmation that a single pivotal Phase 3 trial plus confirmatory evidence will suffice for Biologics License Application submission for Elate Ocular, significantly reducing development expenses and accelerating the pathway to market.

N1 Holdings delivered record settlement volumes and a 127% surge in quarterly cash receipts despite challenging market conditions, driven by disciplined funding and operational efficiency.

Wide Open Agriculture appoints Craig Swan as CEO and pivots to a contract manufacturing model to improve economics and scale lupin protein production, while receiving a A$1.69 million R&D tax rebate.

Papyrus Australia (ASX: PPY) has secured $175,000 through a share placement alongside convertible note conversions and related party loans, aiming to fund commercialisation and fulfil a key contract for biodegradable Collar Keeper® products.

Resolution Minerals has raised A$20 million in a strongly supported institutional placement to accelerate exploration and development at its US Horse Heaven Project, while preparing for a NASDAQ listing to boost its US market presence.

Phoslock Environmental Technologies reported a stable sales volume and improved cash flow compared to last year, while ramping up production after reopening its Chinese factory. The company is advancing R&D on a new lanthanum product and faces ongoing legal challenges with mediation set for June.

Dreadnought Resources has obtained regulatory approval for open pit mining at its Star of Mangaroon gold project in Western Australia, advancing its strategy to become a self-funded explorer by outsourcing development and processing.

Ovanti Limited is issuing a bonus tranche of Loyalty Options to shareholders at no cost, exercisable at a modest $0.025, potentially raising close to $1 million if fully converted.

Little Green Pharma has pushed back the Federal Court hearing for its Cannatrek acquisition to late May, setting a new timetable that includes a shareholder vote on May 22 and implementation targeted for June 1.

First Graphene has demonstrated a significant carbon reduction in cement roof tiles through a UK production trial with FP McCann, using graphene-enhanced cement to lower emissions and material use.

Radiopharm Theranostics (ASX: RAD) has completed enrolment in its Phase 2b RAD 101 brain metastases imaging trial with interim data showing 90% concordance with MRI, while progressing early-stage trials of therapeutic candidates RAD 202, RV-01, and RAD 402. The company reported a $19.2 million cash balance at quarter end, down from $34.5 million, with a net operating cash outflow of $14.9 million driven by milestone-related R&D and staff costs.

Barton Gold has launched a ~3,000m diamond drilling campaign at its Tunkillia project, aiming to upgrade resources and support a Mining Lease application by the end of 2026. The project builds on a strong May 2025 study projecting robust returns amid rising gold and silver prices.