Latest Therapeutics News

Invion Limited has addressed ASX queries over the timing and content of its cleansing notice, confirming encouraging early results from its Phase I/II non-melanoma skin cancer trial using Photosoft™ technology.

PYC Therapeutics has secured Safety Review Committee approval to increase dosing in its clinical trial for a novel treatment targeting Autosomal Dominant Optic Atrophy, a rare blinding genetic disease. This milestone marks a significant step forward in the development of PYC-001, a first-in-class RNA therapy.

Olympus Corporation has launched a nationwide emphysema screening campaign in the US powered by 4DMedical’s AI lung density analysis, marking a major commercial milestone for the Australian medtech firm.

Chimeric Therapeutics has secured a $2.5 million advance against its FY25 R&D tax incentive, bolstering funding for its clinical trial pipeline and operational needs. This move complements recent capital raises and underscores the company’s strategic financial management amid its oncology-focused cell therapy development.

Syntara Limited’s lead drug candidate SNT-5505 has secured FDA Fast Track designation, expediting its development for treating myelofibrosis, a rare and serious blood cancer with limited therapies.

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.

Firebrick Pharma has published its pivotal Phase 3 trial results for Nasodine nasal spray, confirming its effectiveness and safety in treating the common cold, especially when used early.

Nyrada has secured ethics approval to amend its Phase I clinical trial protocol for Xolatryp, allowing testing of higher doses and extended infusion times. This strategic move aims to refine dosing ahead of Phase II trials, with final Phase I results expected by September 2025.

Chimeric Therapeutics has secured FDA Fast Track designation for its CHM CDH17 CAR-T therapy targeting gastroenteropancreatic neuroendocrine tumours, accelerating its path toward regulatory approval and patient access.

Radiopharm Theranostics has initiated dosing in its Phase 1 HEAT trial of 177Lu-RAD202, a novel radiotherapeutic aimed at advanced HER2-positive solid tumors, marking a key step in its clinical development.

InhaleRx has secured swift Human Research Ethics Committee approval for its redesigned IRX-211 Phase 2 trial, expanding participant numbers and potentially bypassing Phase 3 to speed market entry.

Cardiex Limited has gained Therapeutic Goods Administration approval for its CONNEQT Pulse device, paving the way for commercial expansion in Australia alongside its established US presence.