Latest Regulatory Affairs News

Clarity Pharmaceuticals reports robust progress in prostate cancer and neuroendocrine tumour trials alongside a strong cash position of $226.2 million, underpinning its path towards commercialisation.

Alterity Therapeutics has bolstered its Phase 2 data for ATH434 in Multiple System Atrophy and is advancing regulatory plans for a pivotal Phase 3 trial, supported by a robust cash position of A$49.2 million.

Imugene Limited has reported compelling clinical trial results for its off-the-shelf CAR T therapy, azer-cel, alongside FDA validation and a strategic collaboration, while managing cash flow amid cost reductions.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.

Besra Gold Inc has updated its Bau Gold Project resource estimate and is intensifying efforts to secure critical mining lease renewals, while restructuring its operations to sharpen capital discipline and technical oversight.

BlinkLab Limited has delivered strong diagnostic results in its U.S. autism pilot study, exceeding FDA performance thresholds and setting the stage for a pivotal 510(k) trial. The company also expanded its clinical trial network and nears completion of its European ADHD study.

Amplia Therapeutics reports encouraging clinical progress for its pancreatic cancer drug narmafotinib, with a 35% confirmed response rate in the ACCENT trial and FDA support for dose optimisation. The company also uplisted to the US OTCQB market and secured a key patent extending protection to 2040.

Evolution Energy Minerals has ramped up exploration at its Chikundo Copper Project while stabilising its finances and navigating regulatory hurdles in Tanzania. The company is preparing for drilling in 2026 despite a tight cash position.

Avenira Limited has made significant strides in developing its Wonarah Phosphate Project, bolstered by strategic operational appointments and advancing infrastructure plans. Meanwhile, exploration at the Jundee South Gold Project is set to commence in 2026 amid ongoing regulatory challenges.

Mesoblast Limited reported a 60% jump in Ryoncil sales to US$35 million for the December quarter, alongside securing a US$125 million credit facility that enhances its financial flexibility and supports ongoing clinical development.

Dimerix Limited has completed recruitment for its pivotal ACTION3 Phase 3 trial targeting a rare kidney disease, secured positive FDA feedback on trial endpoints, and reported a solid cash position of AU$38.5 million at the end of 2025.

Zelira Therapeutics has raised nearly US$33 million to fund clinical trials for its HOPE 1 cannabinoid-based medicine targeting autism, while also benefiting from a $1.07 million R&D tax refund.