Latest Regulatory Approvals News

Invion Limited secures a pivotal FDA Orphan Drug Designation for its lead candidate INV043, targeting anal cancer with promising preclinical results and a fast-tracked development path.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

EV Resources has signed a strategic Memorandum of Understanding with Wogen Resources and Xcelsior Capital Advisors to fund and advance its Los Lirios Antimony Project in Mexico, aiming to establish a 100 tonne-per-day processing plant.

Duxton Farms has received Foreign Investment Review Board approval for its strategic merger and updated its timetable for key shareholder and court approvals, alongside a $4.55 million capital raise.

Neurizon Therapeutics reports encouraging topline results from its Phase 1 Open-Label Extension study of NUZ-001, demonstrating long-term safety and a significant survival advantage in ALS patients. These findings pave the way for the pivotal HEALEY ALS Platform Trial planned for late 2025.

LTR Pharma’s intranasal ED treatment SPONTAN achieves peak effect up to five times faster than oral tablets, according to new peer-reviewed clinical data published in a leading European journal.

Novomatic AG has launched an unconditional A$1.00 per share cash takeover offer for all remaining shares in Ainsworth Game Technology Limited, representing a 35% premium to pre-announcement prices. The offer runs alongside a previously announced scheme and comes with unanimous support from Ainsworth's Independent Board Committee.

TG Metals reports encouraging assay results from historical stockpiles and secures approvals for in-pit drilling at its Van Uden Gold Project, aiming to unlock near-term cash flow opportunities.

Vicinity Centres has announced an ordinary unfranked dividend of AUD 0.0605 per security for the six months ending June 2025, accompanied by a Dividend Reinvestment Plan offering a 1% discount.

The Lottery Corporation reported a resilient FY25 with $3.7 billion revenue and a 3.1% dividend increase, driven by digital sales growth and strategic game refreshes despite a revenue decline from a record jackpot year.

Mount Gibson Iron reported a significant net loss for FY25 amid weaker iron ore prices but is pivoting towards gold with a major acquisition in the Northern Territory.

Mount Gibson Iron Limited reported a substantial net loss for FY2025 amid iron ore price drops and operational challenges, while announcing a strategic acquisition in the gold sector.