Latest Regulatory Milestones News

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

Riversgold has kicked off a focused nine-day diamond drilling campaign at its Northern Zone Gold Project near Kalgoorlie to gather essential rock strength data for pit design, as it nears a key mining lease grant and development partnership with MEGA Resources.

Bio-Gene Technology is progressing critical toxicology studies for Flavocide with a targeted APVMA submission in March 2027, while forging a strategic partnership to launch Qcide insecticides in Japan by late 2026.

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

Island Pharmaceuticals has cleared a major regulatory hurdle with the US FDA, confirming a clinical development path for its antiviral Galidesivir under the Animal Rule. Backed by a $9 million capital raise and strategic partnerships, the company is poised for potential US government procurement and biodefence market entry.

Brazilian Rare Earths (ASX: BRE) has reported substantial expansion of its Monte Alto rare earth project with ultra high-grade drilling results and validated low-temperature processing delivering 97% recovery. The company also secured a Trial Mining Licence enabling early production and bulk shipments.

Alterity Therapeutics has secured FDA alignment on the chemistry and manufacturing controls for its ATH434 Phase 3 trial in Multiple System Atrophy, marking a pivotal regulatory milestone ahead of the planned mid-2026 End-of-Phase 2 meeting.

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.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

BMC Minerals has cleared a major regulatory milestone for its ABM Mine in Yukon and reported thick, high-grade massive sulfide intercepts at its Krakatoa Zone, supporting resource expansion and a 2027 Final Investment Decision target.

QX Resources (ASX: QXR) secured all exploration licences for its Madaba Uranium Project in Tanzania, confirming high-grade surface uranium and advancing its 2026 exploration program with $1.23 million funding. Preparations are underway for a heli-borne survey and maiden drilling campaign.

De.mem Limited has extended its growth streak with record quarterly cash receipts of approximately $10.4 million, a 31% increase year-on-year, alongside positive operating cash flow of $504,000 for the March 2026 quarter.