Latest Clinical Pipeline News

Immuron Limited has responded to an ASX price query following a sharp rise in its share price and trading volume, confirming no undisclosed information but pointing to a recent CEO presentation as a possible driver.

Neuren Pharmaceuticals reported a 15% rise in 2025 royalties from DAYBUE®, boosted by strong US sales and a new powder formulation launch. The company is progressing its pivotal Phase 3 trial for NNZ-2591 in Phelan-McDermid syndrome and reassessing capital management amid solid cash reserves.

Amplia Therapeutics and ANZGOG have initiated a clinical trial to test narmafotinib combined with chemotherapy in ovarian cancer patients unresponsive to platinum-based treatment, aiming to improve surgical outcomes and explore biomarker insights.

Racura Oncology reported robust progress in Q3 FY2026, including launching a key lung cancer trial and unveiling a novel blood test for cardioprotection, supported by a solid $19.38 million cash position.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.

Alterity Therapeutics has secured encouraging regulatory feedback from the FDA on its ATH434 Phase 3 program for Multiple System Atrophy, marking a critical step towards pivotal trial initiation.

Cynata Therapeutics has completed the 100-day primary evaluation period for its Phase 2 trial of CYP-001 in acute graft versus host disease, with results expected in June 2026. This milestone marks a critical step for the biotech’s lead cell therapy candidate in a condition with few effective treatments.

Radiopharm Theranostics has initiated dosing in its Phase 1 clinical trial of RAD 402, a novel radiolabelled antibody targeting KLK3 in advanced prostate cancer. Early data from the trial’s initial dose levels are expected in the second half of 2026.

Island Pharmaceuticals has partnered with the Burnet Institute to explore new antiviral applications for its lead drugs, targeting measles, chikungunya, and Ross River virus. This collaboration leverages existing data and government funding to enhance the company’s clinical pipeline without major capital outlay.