Latest Regulatory Submissions News

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Immutep Limited’s Phase II trial of eftilagimod alfa combined with radiotherapy and KEYTRUDA in soft tissue sarcoma patients has exceeded its primary endpoint, showing a 51.5% median tumor hyalinization rate, more than triple the historical standard. These promising results, presented at ESMO 2025, suggest a potential breakthrough in a challenging cancer indication.

TrivarX Limited has announced the acquisition of Stabl-Im, a novel stable isotope MRI technology for early brain tumor detection, backed by a $4.2 million capital raise including investment from biotech leader Dr Daniel Tillett.

Immutep Limited has confirmed 30 mg as the optimal biological dose for its immunotherapy efti, following FDA approval of Project Optimus requirements. This milestone paves the way for the US launch of its pivotal Phase III lung cancer trial.

Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

EMVision Medical Devices launches a $2 million Share Purchase Plan offering shares at a 16.4% discount, bundled with free options exercisable at $3.40, aiming to bolster clinical and commercial milestones.

EMVision Medical Devices has initiated a unique pre-hospital study in Melbourne to test its First Responder Brain Scanner within one of the world’s few Mobile Stroke Units, aiming to enhance stroke diagnosis and accelerate commercialisation.

Micro-X Ltd has secured a $4.4 million Australian Government grant to develop and trial a portable Head CT scanner designed for standard ambulances, aiming to transform emergency stroke care with faster diagnosis and treatment.

Neurizon Therapeutics has locked in a significant R&D tax incentive advance covering overseas and domestic development costs for its lead ALS drug candidate NUZ-001, accelerating its clinical progress with a $5.6 million rebate expected in 2025.

Orthocell’s nerve repair device Remplir is being adopted in Australia for nerve-sparing prostate cancer surgeries, aiming to reduce erectile dysfunction and urinary incontinence post-operation. This development could significantly expand Remplir’s market reach globally.