Latest Regulatory Incentives News

Neuren Pharmaceuticals has initiated a discretionary on-market share buy-back program of up to 5%, citing a strong cash position and undervaluation relative to internal and analyst assessments.

Neuren Pharmaceuticals has received detailed feedback from the US FDA on its clinical development plans for NNZ-2591 targeting hypoxic ischemic encephalopathy and Pitt Hopkins syndrome, paving a clearer path forward despite some delays.

Island Pharmaceuticals has raised $9 million to advance its antiviral drug Galidesivir through the FDA’s Animal Rule pathway, targeting inclusion in the US Strategic National Stockpile for biodefense viruses.

Recce Pharmaceuticals has secured a second Cooperative Research and Development Agreement with the U.S. Army Institute of Surgical Research to test its RECCE 327 Gel in burn wound infection models, underscoring growing military interest in its synthetic anti-infectives.

Neuren Pharmaceuticals’ partner Acadia projects DAYBUE sales to reach around US$700 million by 2028, driven by US market expansion and international approvals. The launch of a new formulation and ongoing clinical trials in Japan underpin this optimistic outlook.

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.

Neuren Pharmaceuticals has secured Health Canada approval to expand its pivotal Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome into Canadian sites, complementing ongoing US enrolment.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

Recce Pharmaceuticals has reported compelling preclinical results for its inhaled anti-infective RECCE 327, demonstrating potent activity against multidrug-resistant pneumonia bacteria in mice models.

Osmond Resources has released confirmatory assay results from its Orión EU Critical Minerals Project in Spain, revealing high-grade titanium, zirconium, hafnium, and rare earth element mineralisation. These findings reinforce the project's potential as a globally significant source of critical minerals.

Osmond Resources has reported exceptional assay results from its first drill hole at the Orión EU Critical Minerals Project, confirming high-grade titanium, zircon, and rare earth mineralisation. The discovery positions the project as a significant potential supplier of critical minerals within the EU.

FleetPartners has acquired Remunerator, a seasoned salary packaging and novated lease provider, enhancing its product suite and market position in the leasing sector.