Latest Regulatory Milestones News

AVITA Medical reported a strong 30% increase in Q4 2024 commercial revenue and amended its credit agreement with OrbiMed to adjust revenue covenants through 2026. The company is poised for significant growth with new product rollouts and expects profitability by year-end 2025.

AVITA Medical reported a robust 30% increase in Q4 2024 commercial revenue alongside key FDA clearances, setting the stage for ambitious growth in 2025.

Pure Foods Tasmania Limited (ASX: PFT) will recommence trading on the ASX from 14 February 2025 following the lifting of its suspension after submitting reissued financial statements with an unqualified audit opinion.

VHM Limited has unveiled a staged development plan for its Goschen Rare Earths and Mineral Sands Project, targeting first production by late 2026 and a scalable expansion to 5Mtpa by 2029 with robust financial returns.

Cavalier Resources has completed and submitted all necessary mining approvals for the Crawford Gold Project, moving decisively toward production amid strong gold prices and ongoing funding talks.

Telix Pharmaceuticals has gained UK MHRA approval for Illuccix, its advanced prostate cancer PET imaging agent, promising to alleviate supply shortages and improve diagnostic accuracy across the UK.

EMVision Medical Devices has secured US ethics approval for its pivotal multi-centre trial of the EMVision emu™ brain scanner, paving the way for a March 2025 trial start aimed at FDA clearance.

Poseidon Nickel Limited’s shares have been suspended from trading following court approval of Horizon Minerals’ acquisition scheme, marking a pivotal step in the nickel miner’s corporate evolution.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.

BlinkLab has secured North Shore Pediatric Therapy as the second US clinical site in its autism diagnostic study, enhancing recruitment and data quality with a leading Chicago-based specialist.

CLINUVEL has released preliminary data from its CUV052 study showing SCENESSE® is well tolerated in adolescent erythropoietic protoporphyria (EPP) patients, supporting a planned label extension in 2025.

Cleo Diagnostics has responded to an ASX price query following a notable rise in its share price and trading volume, underscoring its patented ovarian cancer detection technology and ongoing U.S. clinical trials.