Latest Regulatory Submissions News

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.

PYC Therapeutics reports substantial progress across all four of its drug development programs in Q4 2024, including key regulatory designations and clinical milestones that set the stage for pivotal trials in 2025.

Actinogen Medical accelerates recruitment in its pivotal XanaMIA Alzheimer's trial while securing a strong cash position of $22.9 million, underpinning its late-stage development and commercial readiness.

Respiri Limited reports a standout December quarter marked by a 67% surge in patient program enrolments and robust revenue growth, bolstered by strategic acquisition synergies from Orb Health. The company is poised for further expansion in 2025 amid promising contract negotiations and evolving US healthcare reimbursement policies.