Latest Regulated Markets News

CleanSpace's AGILE respirator has achieved AS/NZS 17420.2:2021 certification, paving the way for commercialisation in Australia and New Zealand alongside its recent European approval.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Little Green Pharma (ASX:LGP) has completed its merger with Cannatrek, creating a dominant player in Australia and Europe’s medicinal cannabis market with a majority stake held by former Cannatrek shareholders.

RAS Technology Holdings has locked in new contracts and extensions expected to add at least $2 million in annualised revenue, reinforcing growth in wagering technology and international markets.

Dataworks has officially launched BetGuard, iGaming Ontario's Centralised Self-Exclusion tool, alongside a dedicated Contact Centre, marking its expansion into a second regulated jurisdiction for responsible gambling technology.

Bioxyne has locked in a two-year, $50 million exclusive supply agreement with German pharmaceutical distributor ADREXpharma, granting exclusive rights to its Dr Watson® brand in Germany and reinforcing its foothold in Europe’s largest medicinal cannabis market.

Pathkey.AI appoints Andrew Farnsworth as CEO, leveraging his defence and AI expertise to drive commercialisation of TrialKey and Chipforge platforms.

Bioxyne expands its LATAM footprint by securing the first international medicinal cannabis flower supply agreement in Costa Rica, with initial shipments valued over $500,000 planned before June 2026.

Algorae Pharmaceuticals has struck an exclusive commercial and licensing agreement with global pharma Zydus Lifesciences to bring 10 injectable, oral, and specialty medicines to Australia and New Zealand, pending regulatory approvals.

Harvest Technology Group sharpened its international defence focus in Q1 2026, onboarding NATO and commercial clients to its Nodestream platform, progressing new video features, and appointing Jeff Sengelman as Executive Chair amid CEO transition.

Ainsworth Game Technology’s FY25 results reveal a mixed bag: a 9% dip in underlying profit to $21.1 million, a hefty $43.1 million goodwill impairment tied to North America, and a strategic pivot with a new acting CEO. Strong Asia Pacific growth and new product launches contrast with margin pressures and a shrinking cash position.

Bioxyne Limited posted a record $21.3 million revenue in Q3 FY26, driven by strong demand for medicinal cannabis and psychedelics. The company secured a manufacturing agreement with Aurora Cannabis and initial orders for GMP psilocybin capsules, reaffirming FY26 guidance.