Latest Therapeutics News

Algorae Pharmaceuticals has reached a key regulatory milestone as the TGA accepts its initial registration dossier, paving the way for potential commercialisation of its generic medicines in Australia and New Zealand.

Pathkey.AI has secured a significant commercial contract with Imunexus Therapeutics, deploying its AI-driven TrialKey platform to enhance early-phase clinical trial design and capital raising efforts.

Emyria Limited has launched a targeted recruitment campaign in New South Wales to establish its fourth state-based clinical operation, aiming to tap into Australia's largest mental health market amid rising psychological injury claims.

Arovella Therapeutics has demonstrated that its novel CLDN18.2-targeting CAR incorporated into iNKT cells effectively eliminates pancreatic and gastric cancer cells in vitro, with IL-12-TM armouring enhancing potency and durability.

AVITA Medical has lodged a new $200 million shelf registration with the SEC, renewing its capacity to issue various securities in the US market. While no immediate capital raising is planned, this move preserves the company’s financial agility for future growth opportunities.

Bioxyne Ltd has secured a manufacturing agreement with global cannabis giant Aurora Cannabis, marking a major step in its international expansion of pharmaceutical-grade medicinal cannabis products.

Paradigm Biopharmaceuticals has achieved 50% patient enrolment in its pivotal Phase 3 trial for injectable pentosan polysulfate sodium, advancing steadily towards an interim analysis expected in August 2026.

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.

Algorae Pharmaceuticals has launched a second collaboration with Peter MacCallum Cancer Centre to validate AI-predicted drug combinations across multiple cancer types, aiming to accelerate its drug development pipeline.

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.

Eve Health Group is advancing its proprietary reformulation platform with two fast-onset products launched under Australia's SAS-B pathway, targeting large underserved markets in women's and men's health. The company’s capital-light, partner-led model aims for rapid revenue growth post-ARTG registration.