Latest Clinical Development News

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.

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.

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.

PYC Therapeutics reports sustained vision improvements in patients with Retinitis Pigmentosa type 11 treated with VP-001, showing promising safety and efficacy up to 18 months. The company plans to engage the FDA in early 2026 to finalize pivotal trial design.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.

Radiopharm Theranostics has successfully enrolled the second cohort in its Phase 1 trial of 177Lu-RAD204, with the Data Safety Monitoring Committee greenlighting a dose increase to 90mCi for the third cohort. Early results show promising tumor targeting and safety in multiple advanced cancers.

Neurotech International has received a $4.73 million R&D tax incentive refund, reinforcing its clinical development efforts in paediatric neurological disorders. The funds will support ongoing trials and working capital needs.

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.