Latest Fda News

Invion Limited has affirmed its compliance with ASX disclosure rules following the US FDA’s granting of Orphan Drug Designation for its anal cancer treatment candidate INV043. The company detailed the timing and verification process behind its announcement.

Tetratherix Limited reports its first financial results as a listed company, revealing a $9.4 million statutory loss driven by R&D and listing costs, alongside a robust $29.3 million cash position post-IPO. The company highlights key operational milestones and outlines strategic plans to accelerate commercialisation across its innovative biomaterial platform.

Dimerix Limited reported a 22% reduction in its FY2025 loss to $13.25 million, driven by strong licensing revenues and advancing its pivotal Phase 3 clinical trial for DMX-200. The company secured new global partnerships valued at up to AU$1.4 billion, bolstering its cash reserves and commercial prospects.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

Tetratherix Limited reported a $9.4 million statutory loss for FY25 amid significant R&D and operational investments, successfully listing on the ASX and progressing multiple clinical and manufacturing initiatives.

Imagion Biosystems reported a $1.66 million loss for the half-year ending June 2025 while progressing its MagSense® HER2 Imaging Agent towards a Phase 2 FDA trial and securing $3.5 million in new funding.

Nova Eye Medical Limited reported a 25% increase in revenue to AUD 29.3 million for FY2025, driven by strong sales in its glaucoma surgical devices segment, yet posted a net loss after tax of AUD 9.1 million. The company raised AUD 6.2 million through a share placement to support growth initiatives.

Mesoblast Limited is set to release its full-year financial results and operational highlights for 2025, spotlighting its FDA-approved cell therapy and expanding global partnerships.

Optiscan Imaging Limited has launched a $17.75 million fully underwritten entitlement offer to fund clinical trials, regulatory approvals, and product development. Peters Investments underwrites the offer, potentially increasing its stake to nearly 39%.

Optiscan Imaging Ltd has launched a fully underwritten $17.75 million entitlement offer to fund clinical trials and regulatory clearances for its medical devices, marking a pivotal step in its transition to a commercial medical device manufacturer.

Cleo Diagnostics reported a $4 million loss for FY2025 while making significant strides toward FDA approval of its novel ovarian cancer blood test. The company is progressing clinical trials and scaling manufacturing in preparation for market entry.

Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.