Amplia Therapeutics (ASX:ATX) has moved a step closer to a pivotal clinical program for its lead FAK inhibitor, narmafotinib, after receiving favourable feedback from the US Food and Drug Administration.

BCAL Diagnostics (ASX:BDX) is preparing for a significant expansion in early cancer detection, confirming it will bring two blood-based tests for pancreatic and ovarian cancer to the Australian market in January 2026.

Dimerix (ASX:DXB) has taken another step forward in its pivotal ACTION3 Phase 3 trial for focal segmental glomerulosclerosis, announcing that the study’s seventh scheduled Independent Data Monitoring Committee review has been completed with no safety concerns raised.

Nyrada (ASX:NYR) is progressing steadily toward the next stage of clinical development for its lead cardioprotective drug candidate, Xolatryp, with the company confirming that its Phase 2a trial remains on track to commence in March 2026.

Cleo Diagnostics (ASX:COV) has taken a significant step toward its planned U.S. market launch, appointing prominent gynaecologic oncologist Dr Nicholas Lambrou as its first U.S.-based Key Opinion Leader.

Tryptamine Therapeutics (ASX:TYP) has reached another critical milestone in its program to treat Binge Eating Disorder , confirming the enrolment of a second participant in its clinical trial of TRP-8803, an intravenous formulation of psilocin.

OncoSil Medical (ASX:OSL) used its 2025 Annual General Meeting to highlight a year of decisive regulatory and clinical progress that positions the company for accelerated commercial growth.

Australia’s vaccine and infectious-disease research sector has received a significant boost with the official launch of Biointelect Venturer, a new national incubator designed to accelerate local scientific breakthroughs from early discovery toward commercial reality.

Radiopharm Theranostics (ASX:RAD) has hit a significant milestone in its Phase 2b clinical trial evaluating RAD101, announcing that the study has now reached 50 per cent of its planned patient enrollment.

Mesoblast (ASX:MSB) has appointed experienced biotechnology and pharmaceutical finance executive James M. O’Brien as its new US-based Chief Financial Officer, marking a significant step in the company’s transition toward becoming a fully integrated commercial organisation.

Race Oncology (ASX:RAC) has announced a significant expansion of its clinical development strategy, unveiling two new programs for its lead asset, RC220, in acute myeloid leukaemia and EGFR-mutated non-small cell lung cancer.

Syntara (ASX:SNT) has achieved a significant regulatory milestone, announcing it has received a positive opinion from the European Medicines Agency on its application for Orphan Drug Designation for amsulostat (SNT-5505) in myelofibrosis.

Argent BioPharma (ASX:RGT) has taken a significant step toward its next phase of growth, securing a new $11 million financing facility from US-based venture fund C/M Capital to complete the acquisition of AusCann Group assets and accelerate commercial development plans.

Recce Pharmaceuticals (ASX:RCE) has announced the passing of its founder, Dr Graham JH Melrose, a distinguished scientist, inventor and long-time champion of innovative anti-infective technologies.

PYC Therapeutics (ASX:PYC) has reported encouraging long-term data from its ongoing Phase 1/2 clinical program for VP-001, an investigational treatment targeting Retinitis Pigmentosa type 11.

Biotron (ASX:BIT) has released new data demonstrating significant progress in its Hepatitis B Virus development program, with its lead candidate BIT-HBV001 showing potent antiviral effects across multiple laboratory and animal models.

Noxopharm (ASX:NOX) has reached a new milestone in its development of SOF-SKN, announcing that the first dose has now been administered in Part Two of the HERACLES clinical trial.

Pathkey.AI (ASX:PKY) has announced a new partnership with Melbourne-based consultancy Armstrong Clinical, combining advanced artificial intelligence with deep human expertise in clinical development strategy to help sponsors design smarter, more successful early-phase studies.