Latest Fda News

Nexsen Limited has successfully completed an $8 million IPO and ASX listing, while advancing its kidney diagnostic tests and initiating clinical trials for its GBS Rapid Sensor targeting expedited FDA approval.

EMVision Medical Devices has successfully closed an oversubscribed Share Purchase Plan, raising $2 million and bringing total recent capital to $14 million. This funding positions the company to advance pivotal clinical trials and regulatory milestones for its innovative neurodiagnostic devices.

The Treasurer has expressed preliminary concerns that Cosette Pharmaceuticals’ proposed acquisition of Mayne Pharma could harm Australia’s economy, citing plans to close a key Adelaide manufacturing site. Mayne Pharma disputes these claims and urges a resolution before the scheme deadline.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug candidate NUZ-001 and strengthened its balance sheet with a $5.2 million capital raise. The company is now poised to enter the pivotal HEALEY ALS Platform Trial, marking a significant step forward in its neurodegenerative disease program.

Alterity Therapeutics reports strengthened efficacy signals for ATH434 in Multiple System Atrophy and secures a robust cash position to fuel upcoming Phase 3 trials.

Immuron Limited reports progress on its IMM-529 FDA application and a delay in Travelan® clinical trial results due to a U.S. government shutdown, with key data now expected in late November.

Argenica Therapeutics reports ARG-007 is safe in acute ischemic stroke patients and shows promising efficacy signals in a high-risk subgroup, paving the way for a focused Phase 2b trial.

Invion Limited has secured a pivotal FDA Orphan Drug Designation for its lead cancer drug INV043, bolstered its balance sheet with nearly $1.8 million in new funding, and progressed clinical trials targeting skin and anogenital cancers.

Bubs Australia reported a 30% increase in net revenue to $25.6 million for Q1 FY26, driven by robust US sales and a return to profitability with positive EBITDA. Despite inventory challenges in other regions, the company maintains a solid cash position and anticipates FDA approval by year-end.

PainChek Ltd has achieved a pivotal FDA De Novo clearance for its AI-driven Adult pain assessment app, unlocking the US market and driving its annual recurring revenue to $5.6 million. The company also launched its Infant app, targeting a vast global market of pre-verbal children.

PainChek has secured FDA De Novo clearance for its Adult App, opening immediate access to a $175 million AUD US long-term care market and advancing its Infant App commercialization targeting a $15 billion AUD global opportunity.

Percheron Therapeutics reports encouraging phase I clinical results for HMBD-002, confirming safety and early efficacy signals, while gearing up for a multi-arm phase II trial in 2026.