Latest Fda News

Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.

Orthocell Limited has reported a record $3.2 million revenue for the December 2025 quarter, marking its seventh consecutive quarter of growth, fuelled by expanding sales of its nerve repair product Remplir in the US and other international markets.

Tetratherix has inked a global exclusive distribution agreement with healthcare giant Henry Schein, paving the way for its first bone regeneration product, Tegenix, to enter major markets in 2026. Concurrently, the company has begun building an advanced manufacturing facility to meet expected global demand.

Zelira Therapeutics has raised nearly US$33 million from ThirdGate Capital to advance its HOPE® 1 drug targeting autism-related Phelan-McDermid Syndrome through FDA clinical trials. This funding milestone sets the stage for pivotal regulatory progress in the US.

Vitasora Health has completed an A$11 million capital raise, including a cornerstone investment, bolstering its balance sheet to support ambitious growth in the US healthcare market. The company targets cash flow breakeven by the end of FY2026 amid expanding patient programs and new partnerships.

Orthocell has increased its investment in Marine Biomedical to 11.7%, securing exclusive distribution rights to the innovative PearlBone™ technology as it nears FDA approval.

4DMedical Limited has raised $150 million through a well-supported institutional placement to accelerate the commercialisation of its innovative lung imaging product CT – VQ™ in the US market. The capital raise comes with minimal dilution and increased insider confidence.

Clarity Pharmaceuticals confirms continuation of its SECuRE Phase II trial for Cu-SAR-bisPSMA without protocol changes, reporting encouraging safety and efficacy data in metastatic prostate cancer patients.

Recce Pharmaceuticals has received a $5.3 million R&D tax rebate from the Australian Taxation Office, providing a significant cash injection to support its innovative synthetic anti-infective drug development programs.

Neuren Pharmaceuticals’ partner Acadia projects DAYBUE sales to reach around US$700 million by 2028, driven by US market expansion and international approvals. The launch of a new formulation and ongoing clinical trials in Japan underpin this optimistic outlook.

The Calmer Co. International Limited has reported its highest ever monthly sales of $910,767 in December 2025, driven by strong wholesale growth and expanding US market presence.

AdAlta Limited has raised A$1.2 million through a strategic placement to advance its innovative PD1 armored MSLN CAR-T therapy for solid cancers, reinforcing its unique 'East to West' cellular immunotherapy approach.