Latest Clinical Trials News

Pathkey.AI’s TrialKey platform continues to validate its AI-driven clinical trial success predictions, with September 2025 seeing an average 43.6% share price increase across flagged biotech stocks.

PainChek Limited has achieved a landmark FDA De Novo classification for its PainChek Adult App, positioning it as the first regulated medical device for pain assessment in the US aged care sector and opening a $100 million annual market opportunity.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.

Immuron Limited has taken a significant step forward by submitting an Investigational New Drug application to the FDA for IMM-529, targeting Clostridioides difficile infection. The company aims to start Phase 2 trials in early 2026, addressing a critical unmet need in infectious disease treatment.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent, progressing toward a Phase 2 clinical trial with strong collaborations and a recent AU$3.5 million capital raise.

The U.S. FDA has lifted the clinical hold on Neurizon Therapeutics’ lead drug candidate NUZ-001, enabling its entry into a major ALS platform trial set for Q4 2025. This regulatory milestone accelerates the company’s clinical development and opens doors for broader neurodegenerative applications.

Arovella Therapeutics has demonstrated that its novel CLDN18.2 CAR-T cells effectively eliminate pancreatic cancer cells in vitro, matching the performance of a leading competitor’s product. The company is now advancing this CAR into its innovative iNKT cell platform to tackle solid tumours.

Chimeric Therapeutics reports encouraging Phase 1B data from its ADVENT-AML trial, showing safety and multiple complete responses in high-risk AML patients treated with CORE-NK combined with standard therapies.

Cryosite Limited has inked a deal to acquire a strategic freehold warehouse in Auburn, NSW, doubling its storage capacity and positioning itself for significant growth in clinical trial logistics.

Radiopharm Theranostics has received a positive safety recommendation to increase the dose of its radiotherapeutic 177Lu-RAD202 in the Phase 1 HEAT trial for HER2-positive advanced solid tumors, signaling promising early results.

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.