Latest Clinical Development News

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Biotron Limited has completed the initial safety phase of its lead Hepatitis B drug in animal studies, paving the way for efficacy testing in two distinct mouse models. This milestone marks a significant step forward in the company’s antiviral drug development program.

Amplia Therapeutics has secured US ethics approval to launch a Phase 2 trial combining its drug narmafotinib with FOLFIRINOX chemotherapy for advanced pancreatic cancer, marking a key step in its clinical development.

Immutep reports promising Phase I results for IMP761, a novel LAG-3 agonist antibody demonstrating significant T cell inhibition and a clean safety profile, advancing hopes for new autoimmune disease treatments.

CLINUVEL’s Phase II pilot study reveals afamelanotide monotherapy does not trigger repigmentation in vitiligo patients, underscoring the necessity of adjunct NB-UVB phototherapy.

Argenica Therapeutics has reported compelling preclinical results for ARG-007, demonstrating sustained neuroprotection and functional recovery in a ferret model of moderate traumatic brain injury. These findings pave the way for clinical trials targeting a major unmet medical need.

Nyrada’s Phase I clinical trial for its novel drug Xolatryp has cleared safety reviews through four cohorts and will now test higher doses and longer infusions in an expanded trial design.

Island Pharmaceuticals has reported encouraging Phase 2a/b trial results for ISLA-101, demonstrating meaningful reductions in dengue viral load and symptoms in humans. The findings support further clinical development of this antiviral candidate.

PYC Therapeutics has secured Safety Review Committee approval to increase dosing in its clinical trial for a novel treatment targeting Autosomal Dominant Optic Atrophy, a rare blinding genetic disease. This milestone marks a significant step forward in the development of PYC-001, a first-in-class RNA therapy.

Chimeric Therapeutics has secured a $2.5 million advance against its FY25 R&D tax incentive, bolstering funding for its clinical trial pipeline and operational needs. This move complements recent capital raises and underscores the company’s strategic financial management amid its oncology-focused cell therapy development.

Opyl Limited unveils a bold strategic pivot to enhance its AI-driven drug discovery platform, leveraging a vast proprietary dataset and leadership upgrades to redefine clinical trial innovation.

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.