Latest Regulatory Submissions News

Noxopharm has successfully completed key in vitro safety tests for its SOF-SKN™ lupus drug, paving the way for the upcoming HERACLES Phase 1 clinical trial.

Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.

Tissue Repair Limited reports initial patient enrolment in its pivotal Phase 3 trial for TR987®, alongside a robust 35% quarterly sales increase for its TR Pro+® product. The company is also advancing manufacturing and distribution strategies to support growth.

Opthea Limited reports steady progress in its Phase 3 trials for sozinibercept, a novel treatment for wet AMD, supported by a strong cash position and a recent R&D tax incentive.

Gibb River Diamonds secures key agreements to progress gold mining at Edjudina and gains international exposure for its Ellendale Diamond Project, positioning itself for growth across multiple mineral fronts.

PainChek Ltd reports robust growth with 100,000 contracted licences globally and positive FDA clearance progress, alongside a promising launch of its Infant App targeting a vast new market.

Neurotech International has secured a $2.44 million R&D tax incentive refund, strengthening its cash position as it advances clinical trials for paediatric neurological disorders and prepares for regulatory submissions in FY2025.

Alterity Therapeutics has reported positive Phase 2 results for ATH434, showing significant slowing of Multiple System Atrophy progression and a favorable safety profile. The trial demonstrated clinical benefits alongside reductions in brain iron accumulation, a key disease driver.

Zelira Therapeutics has secured a fourth funding tranche of US$681,000, advancing its HOPE® Autism Spectrum Disorder FDA trial process and bringing total funding to US$3.25 million. The company is progressing clinical validation and product development, including the transformation of Zenivol® into a capsule formulation.

LTR Pharma reports compelling clinical results for its nasal spray ED treatment SPONTAN®, demonstrating rapid absorption and strong safety, alongside strategic partnerships and a robust $34 million cash position.

New Murchison Gold Limited reports a significant 39% increase in indicated gold resources at its Crown Prince deposit and secures a strategic ore purchase deal with Westgold, setting the stage for mining to commence mid-2025.

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.