Latest Regulatory Challenges News

Prescient Therapeutics has secured FDA Fast Track designation for PTX-100 in treating relapsed Cutaneous T-Cell Lymphoma and dosed the first patient in its Phase 2a trial, supported by a recent $6.8 million capital raise.

Kingsrose Mining advances its Finnmark exploration with promising new magnetic and conductive anomalies, while BHP withdraws from Central Finland to concentrate resources. Leadership changes and a robust cash position set the stage for an active year ahead.

LCL Resources has secured a A$14 million cash deal plus royalty rights by divesting its Colombian projects to Tiger Gold Corporation, while advancing promising exploration programs in Papua New Guinea.

Taruga Minerals has exercised its option to acquire 100% of the Thowagee Project in Western Australia, reporting promising high-grade polymetallic rock chip and soil sampling results that expand exploration potential.

Change Financial Limited reported a record Q4 FY25 revenue of US$4.0 million, marking a 26% year-on-year increase, alongside positive underlying EBITDA and a strong outlook for FY26.

EDU Holdings reports a modest 2% increase in total student enrolments for its Australian Learning Group in Term 3, 2025, while new student enrolments have sharply declined amid ongoing regulatory challenges.

LTR Pharma has initiated commercial distribution of its nasal spray SPONTAN through Australia's Symbion pharmacy network and is advancing ROXUS development for a US launch in early 2026, while expanding its pipeline with a new intranasal treatment for swallowing disorders.

MEC Resources has boosted its investment in Advent Energy, navigates ongoing PEP-11 permit legal challenges, and highlights promising developments in clean hydrogen production.

ECS Botanics reports a 20% quarterly surge in direct-to-consumer sales and a record medicinal cannabis harvest, supported by an expanded loan facility to fuel further growth.

Carnegie Clean Energy has signed a pivotal Memorandum of Understanding with BiMEP to develop a 6MW wave energy array in Spain’s Basque Country, marking a significant step in commercialising its CETO technology.

Imricor Medical Systems reported significant regulatory and commercial progress in Q2 CY25, including CE mark approvals and expanded clinical trials, while maintaining a strong cash position.

Peak Rare Earths advances its Ngualla project with a proposed A$158 million acquisition by Shenghe Resources, alongside a successful A$7.5 million capital raise and rising rare earth prices.