Latest Regulatory Progress News

Cambium Bio reported a $3.84 million loss for FY25 but secured critical FDA approvals and ethics clearances to initiate Phase 3 trials of Elate Ocular®, supported by a $2.12 million capital raise.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.

Bioxyne Limited delivered a record FY25 with $30.4 million revenue, driven by Australian market growth and new European contracts. The company projects revenue up to $75 million in FY26, fueled by expanded production and international market entries.

Tissue Repair Ltd reported a 27.3% revenue increase to $3.22 million for FY25, driven by new distribution deals and regulatory progress, while continuing to invest heavily in clinical trials and manufacturing scale-up, resulting in a $4.24 million loss.

LTR Pharma’s FY25 results reveal a transformative year highlighted by SPONTAN’s rapid absorption and strategic partnerships that pave the way for US market entry.

Clarity Pharmaceuticals reported a $64.3 million loss for FY2025 alongside significant clinical progress and a $203.6 million placement to fund its radiopharmaceutical pipeline expansion.

CurveBeam AI Limited posted a strong 85% increase in revenue to $12.1 million for FY25, alongside a reduced net loss of $16.8 million. Despite operational improvements and a recent $11.58 million capital raise, the company flags material uncertainty over its ability to continue as a going concern.

Nova Eye Medical has reported a record A$29.3 million in FY25 revenue, driven by sustained US growth and operational improvements, setting the stage for breakeven EBITDA in the first half of FY26.

Neuren Pharmaceuticals reported a robust half-year with an 88% increase in net profit, driven by rising royalties from DAYBUE™ sales and progress in its NNZ-2591 clinical program. The company also completed a $39.6 million share buy-back, underscoring confidence in its growth trajectory.

NH3 Clean Energy has launched the FEED phase for its WAH2 clean ammonia project, advancing environmental approvals and commercial negotiations with potential strategic partners.

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.