Latest Regulatory Strategy News

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

Alterity Therapeutics reports compelling Phase 2 clinical trial results for ATH434 in Multiple System Atrophy, alongside a significant capital raise strengthening its financial position for upcoming regulatory milestones.

Optiscan Imaging Ltd has revealed its next-generation InForm™ pathology imaging device and strengthened its executive team, while reporting a robust cash position supported by a $1.775 million R&D tax refund for the quarter ended 31 March 2025.

Recce Pharmaceuticals reports strong Phase II results for its RECCE® 327 topical gel, achieving a 93% efficacy rate in treating serious skin infections and setting the stage for accelerated Phase 3 trials.

Neurizon Therapeutics received FDA guidance on its IND application for NUZ-001, with a single request for additional animal exposure data but no safety concerns flagged. The company is actively addressing the FDA’s request while evaluating impacts on its ALS trial timeline.

TrivarX has solidified its regulatory strategy for the pivotal MEB-001 trial with the FDA and unveiled a new algorithm that expands its mental health screening reach beyond sleep clinics.

InhaleRx has corrected its quarterly report and revealed a $38.5 million funding deal to fast-track clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, aiming for FDA approval.

InhaleRx has locked in a $38.5 million funding deal with Clendon Biotech Capital, enabling expanded Phase 2 trials for its inhaled breakthrough cancer pain and panic disorder treatments. The company also filed a key international patent, positioning itself for a faster path to FDA approval.

Pacific Edge reports stable test volumes in Q3 FY25 despite Medicare reimbursement uncertainties and seasonal slowdowns, while gearing up for legal action against a flawed Medicare coverage decision.