Latest Clinical Development News

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.

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.

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.

Amplia Therapeutics reports strong progress in its pancreatic cancer drug development, completing the ACCENT trial recruitment ahead of schedule and initiating a new US trial, while managing a $6.57 million loss for FY25.

Dimerix has activated the first clinical trial site in Japan for its pivotal Phase 3 ACTION3 study targeting FSGS, triggering a significant milestone payment from its Japanese partner FUSO Pharmaceutical.

Invion Limited reports no adverse events and early lesion reduction in its Phase I/II non-melanoma skin cancer trial, advancing to dose optimization.

Aroa Biosurgery has reported a robust 23% revenue increase in FY25, achieving profitability and positive cash flow, setting the stage for continued growth in FY26.

Recce Pharmaceuticals has secured a significant patent acceptance in China for its RECCE® anti-infectives, broadening its intellectual property footprint in the world’s second-largest pharmaceutical market.

OncoSil Medical has launched a $8.7 million capital raising via a Share Purchase Plan and Placement, seeking shareholder approval for options issuance and a 400:1 share consolidation.

PYC Therapeutics has secured approval to escalate dosing in its Phase 1a trial of PYC-003 for Polycystic Kidney Disease, moving closer to patient dosing later this year.

Chimeric Therapeutics has progressed its CHM CDH17 CAR-T cell therapy clinical trial to Dose Level 2 after completing Dose Level 1 with no safety concerns, showing encouraging early signs of activity in advanced gastrointestinal cancers.

Island Pharmaceuticals has raised $3.6 million through a strategic share placement to advance its lead antiviral drug ISLA-101’s clinical development and broaden its asset portfolio ahead of pivotal Phase 2a/b trial results.