Latest Administration News

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.

Audeara Limited has secured its largest-ever Australian wholesale purchase order worth $560,000, driving year-to-date wholesale revenues to $1.75 million and matching full FY25 figures. The company is also expanding manufacturing into China, signaling growing international ambitions.

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

Identitii Limited has announced a pro rata non-renounceable rights issue to raise approximately $2.88 million, partially underwritten by Beauvais Capital Pty Ltd. The funds will support the development and commercialisation of its BNDRY platform amid ongoing patent litigation risks.

InhaleRx has boosted its funding facility by $12.6 million to accelerate clinical trials of SRX-25, a novel oral treatment for Treatment-Resistant Depression. This brings total available capital to $52.3 million, positioning the company for pivotal Phase III studies.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

Argenica Therapeutics has demonstrated that its lead drug candidate ARG-007 does not interfere with the clot-busting agent tenecteplase, fulfilling a critical FDA requirement and advancing its stroke therapy development.

Pacific Edge appoints Simon Flood as chairman designate, aiming to leverage his global investment expertise to navigate Medicare reimbursement challenges for its bladder cancer diagnostic tests in the US.

Avecho Biotechnology has received patent allowances in the US and Europe for its proprietary CBD soft-gel formulation, reinforcing its intellectual property ahead of pivotal Phase III insomnia trial results expected in mid-2026.

LTR Pharma has secured ethics approval for its Phase II SPONTAN clinical trial, focusing on pharmacokinetics and dosing in men aged 65 and older. Recruitment begins early 2026 with initial results expected mid-year.