Latest Regulatory Submissions News

Orthocell has secured regulatory approval to sell its nerve repair product Remplir™ in Hong Kong well ahead of schedule, expanding its footprint across key global markets. This milestone complements recent clearances in the US, Canada, and Asia, positioning the company for significant growth in a multi-billion-dollar market.

Orthocell has rapidly expanded its US distributor network for Remplir™, surpassing its target ahead of schedule and positioning itself for imminent sales in the $1.6 billion nerve repair market.

Neurotech International has reported excellent safety and tolerability for its lead drug NTI164 in 28-day GLP toxicology studies, paving the way for regulatory submissions and longer-term clinical development.

Dimerix has inked an exclusive US licensing agreement with Amicus Therapeutics for DMX-200, a promising Phase 3 treatment for FSGS, unlocking $30 million upfront and up to $560 million in milestones.

Memphasys Limited has completed a pivotal Phase III trial confirming its Felix™ System as best-in-class for sperm separation, while advancing regulatory and commercial efforts in China and Brazil supported by fresh capital.

EVE Health Group has executed a binding agreement to acquire Australian biotech Nextract, targeting rapid-onset treatments in the $16 billion global erectile dysfunction and dysmenorrhea markets. The acquisition, supported by a $1.5 million capital raise and share consolidation, marks a strategic shift into regulated pharmaceutical channels.

Avecho Biotechnology has inked a decade-long exclusive licensing agreement with Sandoz for its pharmaceutical-grade cannabidiol capsule targeting insomnia in Australia, backed by a US$3 million upfront payment and promising milestone and royalty streams.

Little Green Pharma reported a robust 40% revenue increase for FY25, driven by strong European sales and the strategic acquisition of Health House. The company also advanced clinical research and secured new therapy funding, positioning itself for continued growth.

Alterity Therapeutics reports compelling Phase 2 clinical trial results for ATH434 in Multiple System Atrophy, alongside a significant capital raise strengthening its financial position for upcoming regulatory milestones.

Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.

Arafura Rare Earths has marked a pivotal quarter with a A$200 million cornerstone equity commitment for its Nolans Project, alongside binding offtake agreements securing two-thirds of its NdPr oxide target amid rising rare earth demand and geopolitical tensions.

Bio-Gene Technology Limited has been awarded two significant grants totaling A$3 million by the US Department of Defense, validating its innovative insecticide technologies Flavocide® and Qcide®. The company is advancing regulatory filings and scaling production to target both military and civilian markets.