Latest Regulatory Submissions News

An independent in vivo study from the University of South Florida reveals ArtemiC™ significantly boosts survival and reduces inflammation in a severe viral model, reinforcing its promise as a novel immunomodulatory therapy.

LTR Pharma has announced that its erectile dysfunction treatment SPONTAN now boasts an 18-month shelf life, surpassing commercial standards and paving the way for international market growth.

Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase in H1 2025, driven by strong sales of its precision medicine products and strategic acquisitions. The company is advancing multiple late-stage clinical trials and expanding its global manufacturing footprint.

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.