Latest Therapeutics News

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.

Aumake Limited has launched Bio-Basic Ergothioneine, marking the debut of its innovative capital-light incubation model aimed at scaling premium health brands with minimal upfront investment.

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.

Invex Therapeutics has ended negotiations on two neurological asset acquisitions following due diligence setbacks and shareholder disputes, while advancing R&D collaborations and managing financial stability.

Advance Zintek reports a robust 26.83% revenue increase in Q1 FY26, driven by strong growth across North America, Australia, and Europe, despite regulatory hurdles impacting zinc oxide sales in Australia.

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.

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.

EVE Health Group has reached a pivotal milestone with the first patient prescriptions of Dyspro™, its cannabinoid-based treatment for dysmenorrhoea and endometriosis, alongside launching an educational platform to support patients and clinicians.

Invex Therapeutics Ltd has had its trading suspension lifted following the announcement of a material acquisition, signaling a pivotal moment for the biotech company.

Invex Therapeutics reveals the collapse of confidential acquisition negotiations following shareholder unrest and potential board changes, clarifying recent unusual trading activity.