Latest Clinical Development News

BPH Global Ltd is pioneering a novel seaweed-based natural formulation targeting male vitality, staking a first-mover claim in this emerging segment of men’s health. The company’s R&D, led by Gaia Mariculture, aims to launch an OTC supplement with potential for clinical validation.

Pathkey.AI has teamed up with Armstrong Clinical to blend AI-driven trial predictions with expert clinical strategy, aiming to boost early-phase trial success and accelerate drug development in Australia and beyond.

NeuroScientific Biopharmaceuticals has initiated treatment of its fourth patient under the Special Access Scheme for StemSmart™, progressing towards a Phase 2 trial targeting severe Crohn’s disease.

Immuron Limited has secured FDA approval for its IMM-529 Investigational New Drug application, clearing the way for a Phase 2 clinical trial targeting Clostridioides difficile infection. This milestone marks a significant step forward for a novel oral antibody therapy addressing a critical infectious disease with high recurrence rates.

Tryptamine Therapeutics has raised $6.1 million to fast-track clinical development of its IV-infused psilocin drug TRP-8803, targeting binge eating disorder and other neuropsychiatric conditions.

Imagion Biosystems reports encouraging findings from its Wayne State University collaboration, supporting a lower dose for its MagSense® HER2 imaging agent ahead of a planned FDA IND submission in Q4 2025.

Immutep Limited has received a significant A$4.6 million cash payment from the French government’s R&D tax incentive scheme, supporting its ongoing immunotherapy clinical programs.

InhaleRx has secured FDA alignment and ethics approvals to progress clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, with patient dosing set to begin soon.

Inhalerx Limited tapped $247,000 from a $38.5 million funding facility to support its clinical trials, while reporting a $310,000 cash burn in operating activities for the September quarter.

Recce Pharmaceuticals has commenced patient dosing in its pivotal Phase 3 trial for diabetic foot infections in Indonesia, supported by promising antibacterial efficacy data and extended funding arrangements.

Chimeric Therapeutics has progressed its CHM CDH17 and CHM CORE-NK clinical trials with promising safety and efficacy signals, while securing a key manufacturing partnership and appointing a renowned haematologist to its board. However, the company faces a pressing cash runway challenge.

Cynata Therapeutics is on track to deliver key clinical trial results in mid-2026 while maintaining a solid cash runway supported by an imminent R&D tax rebate and equity facility.