Latest Therapeutics News

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

Memphasys has secured CE Mark approval for its Felix™ sperm selection system, enabling full commercial rollout across Europe and activating multi-year contracts worth over A$1.3 million. This milestone signals the company’s transition into a revenue-scaling phase with global growth ambitions.

Clarity Pharmaceuticals’ novel diagnostic agent Cu-SAR-bisPSMA has been selected for oral presentation at the prestigious European Association of Urology Congress 2026, following promising Phase II trial results demonstrating superior detection of prostate cancer recurrence.

Chimeric Therapeutics has raised $8.4 million to fully fund its lead CHM CDH17 CAR-T Phase 1/2 trial through Phase 1, while initiating a strategic reset to sharpen focus and reduce costs.

Neurizon Therapeutics has launched a A$24.2 million equity raise to fund the next phase of clinical trials for its lead drug NUZ-001 targeting ALS, supported by a global licensing deal and a flexible convertible note facility.

Neurizon Therapeutics has locked in a $44 million funding package to fully support its lead drug NUZ-001 in the HEALEY ALS Platform Trial, marking a critical step toward potential regulatory approval and broader neurodegenerative applications.

Clarity Pharmaceuticals has secured positive FDA guidance to initiate a pivotal Phase III trial of its Cu-64 SARTATE diagnostic agent for neuroendocrine tumours, aiming to improve detection and patient outcomes.

BioMarin Pharmaceutical’s acquisition of Amicus Therapeutics for US$4.8 billion includes Dimerix’s US licensing agreement, promising significant milestone payments and royalties. This deal strengthens Dimerix’s position as it advances its Phase 3 kidney disease therapy.

INOVIQ Limited has reported compelling preclinical results for its CAR-NK-exosome therapy targeting triple-negative breast cancer, showing significant tumor reduction and perfect survival in treated mice.

PYC Therapeutics reports positive safety outcomes from the initial phase of its clinical trial for PYC-003, a promising treatment for Polycystic Kidney Disease. The drug was well tolerated in healthy volunteers, paving the way for patient dosing and further trials.

Avecho Biotechnology is close to completing recruitment for the interim analysis cohort of its pivotal Phase III trial testing a CBD capsule for insomnia, with results expected in the first half of 2026.

Telix Pharmaceuticals confirms completion of Part 1 enrolment in its ProstACT Phase 3 trial for prostate cancer, with safety data supporting progression to Part 2 and regulatory approvals secured across multiple countries.