Latest Regulatory Submissions News

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.

Avecho Biotechnology has expanded its pivotal Phase III clinical trial for a CBD insomnia treatment by adding new recruitment sites and partnering with pharmaceutical giant Sandoz to boost patient enrolment and regulatory progress.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

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.