Latest Regulatory Pathways News

EVE Health Group has progressed its Libbo pilot clinical study for erectile dysfunction with dosing set for Q4 2026 and achieved a major solubility breakthrough for apixaban, while appointing Ben Rohr as CEO to drive commercial growth.

Argent BioPharma's licensing partner Splash Beverage Group has launched the US veterinary development program for CannEpil®, targeting companion-animal oncology and chronic pain. Led by industry veteran Dr Hunter Land, the initiative follows a defined FDA regulatory pathway and could broaden CannEpil®’s commercial footprint beyond human neurology.

Acrux Limited spotlighted its Female Testosterone Metered Dose Transdermal System (MDTS) at the Bioshares Biotech Summit, revealing positive Phase II data and outlining a clear regulatory and commercial roadmap targeting Hypoactive Sexual Desire Disorder (HSDD) in women.

OD6 Metals has completed its acquisition of the Quinn Fluorspar Project, consolidating 100% ownership of 226 mining claims in Nevada and positioning itself as a potential key domestic fluorspar supplier for the US.

Medallion Metals has wrapped up all key regulatory hurdles for its Ravensthorpe Gold Project, clearing the way for mine development and early production activities to begin this year.

Equus Energy has completed a critical Pre-FEED study for its Equus Gas Project, confirming two cost-effective development pathways and initiating commercial partnerships. The company also strengthened its board and maintains a solid cash position heading into FEED.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial stays on track for November topline results, buoyed by strong open-label extension enrolment and aligned EMA-FDA regulatory advice. A new antidepressant study publication and fresh patents add momentum, supported by a $16.7 million cash runway to mid-2027.

Alterity Therapeutics has cleared a major regulatory hurdle with the FDA endorsing a single pivotal Phase 3 trial for its ATH434 drug in Multiple System Atrophy, setting the stage for trial initiation by the end of 2026.

LTR Pharma’s SPONTAN shows rapid absorption in Phase II interim data while securing key US commercial deals for ROXUS, setting the stage for a US market entry later this year.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.

Argent BioPharma has eliminated US$5.5 million in secured debt through a global licensing agreement for its CannEpil® epilepsy therapy, while completing a key acquisition and advancing clinical trials in veterinary therapeutics.

Patrys Limited is pushing forward with a proprietary injectable formulation of quetiapine targeting the lucrative delirium treatment market, leveraging a faster, lower-cost FDA 505(b)(2) regulatory pathway and strong patent protection.