Latest Regulatory Submissions News

Telix Pharmaceuticals reported a robust 63% increase in revenue to $390.4 million for the first half of 2025, driven by strong Illuccix sales and the acquisition of RLS Radiopharmacies. Despite this growth, the company recorded a net loss of $2.3 million, reflecting increased investments and finance costs.

LTR Pharma’s intranasal ED treatment SPONTAN achieves peak effect up to five times faster than oral tablets, according to new peer-reviewed clinical data published in a leading European journal.

Rhythm Biosciences has advanced its ColoSTAT® diagnostic kits to final production validation, demonstrating consistent detection of colorectal cancer across all stages in a pivotal study. The company is gearing up for regulatory submission and commercial launch later this year.

Recce Pharmaceuticals advances its clinical pipeline with expanded Phase 3 trials in Indonesia and Australia, backed by a $15.8 million capital raise and a $30 million debt facility.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Clarity Pharmaceuticals has bolstered its cash reserves to approximately $288 million following a $203 million institutional placement, while reporting significant clinical progress across multiple copper-based radiopharmaceutical trials targeting prostate cancer and neuroendocrine tumours.

PainChek Limited has secured a A$7.5 million placement to fuel its international expansion, with US FDA clearance for its adult pain assessment app expected imminently. The company reports strong license growth and a 26% revenue increase year-on-year.

Jameson Resources has significantly boosted the economic outlook of its Crown Mountain Hard Coking Coal Project, doubling its pre-tax NPV to US$942 million, while advancing environmental approvals and Indigenous partnerships in British Columbia.

Prescient Therapeutics has secured FDA Fast Track designation for PTX-100 in treating relapsed Cutaneous T-Cell Lymphoma and dosed the first patient in its Phase 2a trial, supported by a recent $6.8 million capital raise.

Actinogen Medical has reached a key milestone in its XanaMIA phase 2b/3 Alzheimer’s trial with over 100 participants enrolled, setting the stage for an interim analysis in January 2026. The company also secured a $13.8 million non-dilutive R&D funding facility to support ongoing development.

Avecho Biotechnology has ramped up recruitment in its pivotal Phase III insomnia trial and is advancing plans for regulatory approval and commercialization of its TPM®-enhanced CBD capsule, aiming to be the first over-the-counter CBD insomnia treatment in Australia.

Nexus Minerals has reported a significant new gold discovery at its Wallbrook Gold Project, highlighted by strong drilling results at the Payns Prospect, while progressing permitting for the Crusader-Templar deposit and maintaining a solid cash position.