Latest Regulatory Affairs News

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.

Neurizon Therapeutics has made significant strides in developing its lead ALS drug candidate NUZ-001, unveiling a new liquid formulation and submitting a key regulatory response to the FDA. Clinical and preclinical data bolster hopes for broader neurodegenerative applications.

Predictive Discovery has released a Definitive Feasibility Study for its Bankan Gold Project, confirming a robust 12.2-year mine life with strong financial returns and advancing key permits toward production.

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.

BPH Energy’s June quarter update highlights ongoing legal proceedings over the PEP-11 permit, promising progress in AI-driven brain monitoring technology, and strategic moves toward hydrogen production facilities, supported by a robust cash reserve.

Neurizon Therapeutics has formally responded to the FDA's clinical hold on its lead ALS drug NUZ-001, submitting new animal safety data. The company aims to join the HEALEY ALS Platform Trial by late 2025, pending regulatory approval.

Island Pharmaceuticals reported promising Phase 2a/b trial results for its dengue drug ISLA-101 and secured a strategic acquisition of the broad-spectrum antiviral Galidesivir, bolstering its pipeline and balance sheet.

Bowen Coking Coal’s initial attempt to defer state royalty payments has been declined by the Queensland Revenue Office, prompting plans for a revised proposal amid ongoing debt restructuring efforts.

NeuroScientific Biopharmaceuticals has completed its acquisition of StemSmart technology, reporting promising clinical results in Crohn’s disease and GVHD, alongside a $3.5 million capital raise to fuel next-stage development.

Argenica Therapeutics has dosed the final patient in its Phase 2 trial for ARG-007 in acute ischaemic stroke, with topline results expected in Q3 2025. Meanwhile, the FDA has placed a clinical hold on its US trial application, introducing uncertainty for US development.

Invex Therapeutics has broadened its collaboration with Tessara Therapeutics to explore Exenatide’s potential in Alzheimer’s disease, while successfully renewing key orphan drug designations in Europe and the US.

Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase to $204 million in Q2 2025, launched its new prostate cancer imaging agent Gozellix in the U.S., and advanced key clinical trials despite an ongoing SEC inquiry.