Latest Clinical Trials News

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.

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.

Opthea Limited faces a pivotal moment as four board members resign following disappointing Phase 3 trial results and a major workforce reduction. The company’s future hinges on ongoing funding negotiations amid trading suspensions.

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.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

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

Noxopharm has secured ethics approval to commence the HERACLES trial, marking the first human study of its novel SOF-SKN™ drug aimed at chronic inflammatory diseases.

Avecho Biotechnology has received $1.66 million from the Australian Government’s R&D Tax Incentive, reinforcing its commitment to a pivotal Phase III trial for its CBD-based insomnia treatment and accelerating its commercial ambitions.

Neuren Pharmaceuticals posted record 2024 financials driven by DAYBUE royalties and advanced NNZ-2591 into Phase 3 trials, while launching a $50 million share buy-back amid volatile market sentiment.

Prescient Therapeutics has reached a pivotal milestone by dosing the first patient in its Phase 2a clinical trial of PTX-100 for relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL), aiming to evaluate safety and efficacy across multiple international sites.

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.