Latest Regulatory Filings News

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.

Embark Early Education has revised the timeline for its conditional takeover bid of Mayfield Childcare, delaying key regulatory filings into early 2026.

AFT Pharmaceuticals delivered a robust first half for FY26, posting 33% revenue growth and a return to profitability, driven by strong Australian sales and recovery in Asia and international markets. The company is advancing its global footprint and R&D pipeline, positioning for sustained growth.

The Supreme Court of Western Australia has approved the share and option schemes for Capricorn Metals’ acquisition of Warriedar Resources, setting the stage for a significant consolidation in the gold exploration sector.

Tissue Repair Limited reports steady progress in its Phase 3 clinical trials for chronic wound treatment and advances regulatory filings for its TR Pro+® product, while gearing up for a major commercial rollout in early 2026.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug NUZ-001, alongside a $5.2 million capital raise and a key licensing deal with Elanco Animal Health. These developments position the company for a critical growth phase in neurodegenerative disease therapeutics.

Helia Group’s 3Q25 APRA data reveals rising gross written premiums despite government scheme pressures, while a Board review confirms strategic focus on the Australian LMI market with significant cost cuts.

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.

Firebrick Pharma reports a $1.94 million cash reserve after a $1.4 million placement, supporting expanded Nasodine sales across Southeast Asia and the US. Board changes and increased operational costs mark a pivotal quarter for the pharmaceutical innovator.

Immutep Limited has confirmed 30 mg as the optimal biological dose for its immunotherapy efti, following FDA approval of Project Optimus requirements. This milestone paves the way for the US launch of its pivotal Phase III lung cancer trial.