Latest Regulatory Affairs News

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

PolyNovo reports a robust 26% increase in group sales for 1H FY26, driven by strong U.S. market expansion and a near tripling of NovoSorb MTX sales. The company also completes a new manufacturing facility, positioning itself for sustained growth.

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.

Island Pharmaceuticals has been granted a key US patent for Galidesivir, extending intellectual property protection through 2031 for treating filoviridae viruses including Marburg and Ebola. This milestone aligns with the company’s clinical development strategy and recent FDA regulatory progress.

Nexsen Limited has initiated FDA engagement for its rapid Group B Streptococcus diagnostic sensor, aiming for expedited US market entry, while bolstering its leadership team and scientific credentials.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Dimerix secures FDA confirmation that proteinuria reduction is a valid primary endpoint for its Phase 3 ACTION3 trial, advancing its kidney disease drug DMX-200 closer to approval.

InhaleRx Limited has successfully closed its entitlement offer and placement, raising $857,730 to support the clinical development of inhaled treatments targeting cancer pain and mental health conditions.

Actinogen Medical has finalized enrollment and begun treatment of all 246 participants in its XanaMIA Phase 2b/3 Alzheimer’s trial, with topline results expected in November 2026. The oral drug Xanamem targets brain cortisol to potentially slow disease progression.

Opthea Limited has announced a strategic pivot to develop OPT-302 for Lymphangioleiomyomatosis (LAM), a rare lung disease affecting women, aiming for ASX reinstatement in 2026. The company leverages strong intellectual property and cash reserves to pursue orphan drug designation and clinical development.