Latest Therapeutics News

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.

Neurotech International has reported positive human pharmacokinetic results for NTI164, a cannabinoid formulation designed for paediatric neurological disorders, confirming rapid absorption and a non-intoxicating profile.

Radiopharm Theranostics has unveiled encouraging preclinical results for its Lu177-B7H3 monoclonal antibody, RV01, paving the way for a mid-2025 Investigational New Drug submission and a Phase 1 trial later that year.

EVE Health Group has initiated stability testing for its novel oral treatments targeting erectile dysfunction and dysmenorrhea, marking a crucial step toward regulatory approval in Australia. The company also finalizes its acquisition of Nextract, the developer behind these innovative formulations.