Latest Clinical Trials News

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

BCAL Diagnostics is preparing to launch its Avantect® pancreatic and ovarian cancer blood tests in Australia by January 2026, following key regulatory approvals and promising clinical data. The company also broadens the reach of its BREASTESTplus™ breast cancer test, targeting a larger segment of women with dense breast tissue.

Cyclopharm Limited reaffirms its ambitious target of 250–300 US Technegas installations by late 2026, driven by FDA approval, CMS reimbursement, and a growing pipeline of healthcare sites. The company reports record half-year revenue growth, signaling strong momentum in the expanding lung imaging market.

Biotron Limited has launched a $1.5 million non-renounceable rights issue to fund its strategic acquisition of Sedarex Limited and support ongoing drug development programs. The capital raise follows shareholder approval and aims to diversify Biotron’s portfolio with a next-generation general anaesthetic.

Tryptamine Therapeutics has enrolled its second patient in a pioneering clinical trial using IV-infused psilocin to treat Binge Eating Disorder, with first dosing scheduled for December and results expected early next year.

Radiopharm Theranostics has secured ethics approval to begin a Phase 1 clinical trial of RAD 402, a pioneering radiotherapeutic targeting advanced prostate cancer using terbium-161. This marks a significant step in developing a potentially safer, more effective treatment option.

Paradigm Biopharmaceuticals has drawn down US$5 million under its convertible note facility to fund the accelerated expansion of its global Phase 3 trial for knee osteoarthritis treatment.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

Race Oncology has announced pivotal new clinical trials for its lead asset RC220, aiming to accelerate regulatory approval in Acute Myeloid Leukemia and tackle resistance in Non-Small Cell Lung Cancer.

Radiopharm Theranostics has reached the halfway mark in enrolling patients for its Phase 2b trial of RAD101, a novel imaging agent targeting brain metastases. Early data suggest RAD101 may outperform MRI in distinguishing tumor recurrence from radiation damage.

Starpharma’s 2025 AGM highlighted breakthrough partnerships and clinical progress, positioning the biotech for growth. Key deals with Genentech and Radiopharm Theranostics underpin a promising pipeline and expanding revenue streams.

Biotron Limited’s lead HBV drug BIT-HBV001 demonstrates superior antiviral activity and synergy with the current standard treatment Tenofovir in preclinical models, advancing hopes for a more effective Hepatitis B therapy.