Latest Regulatory Affairs News

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.

Bio-Gene Technology Limited reported a net loss of AUD 2.58 million for FY2025 while making significant strides in developing its bio-insecticides Flavocide and Qcide, securing US Department of Defense grants and expanding global partnerships.

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

An independent in vivo study from the University of South Florida reveals ArtemiC™ significantly boosts survival and reduces inflammation in a severe viral model, reinforcing its promise as a novel immunomodulatory therapy.

Neuren Pharmaceuticals has initiated the first US investigational site for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, marking a significant milestone in addressing this rare neurodevelopmental disorder.

INOVIQ Limited reported a $6.9 million net loss for FY25 while making significant strides in its exosome-based cancer diagnostics and therapeutics pipeline, including a breakthrough ovarian cancer screening test and promising CAR-exosome therapy results.

LTR Pharma has announced that its erectile dysfunction treatment SPONTAN now boasts an 18-month shelf life, surpassing commercial standards and paving the way for international market growth.

Resolute Mining reported a strong H1 2025 with revenue up 31% driven by soaring gold prices, even as production dipped due to operational challenges. The company advances key projects and maintains full-year guidance amid strategic acquisitions.

Prescient Therapeutics reported an 11.1% reduction in net loss for FY2025, progressing its lead candidate PTX-100 into Phase 2a trials with FDA Fast Track and Orphan Drug designations, supported by a recent $9.8 million capital raise.

LTR Pharma’s intranasal ED treatment SPONTAN achieves peak effect up to five times faster than oral tablets, according to new peer-reviewed clinical data published in a leading European journal.

Neurizon Therapeutics faces a delay in FDA review for its lead ALS therapy NUZ-001, with a new decision expected by early October amid agency-wide staffing challenges.

Argenica Therapeutics has received detailed FDA feedback outlining specific data requirements to lift the clinical hold on its ARG-007 stroke trial in the US, setting a clear path forward for its neuroprotective drug.