Latest Safety News

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

SenSen Networks reported a 17% increase in annual recurring revenue to $11 million and positive operating cash flow of $0.9 million in Q3 FY26 despite supply chain disruptions delaying some projects. The company’s full-year EBITDA is expected to improve significantly over FY25.

Chimeric Therapeutics' CHM CORE-NK cell therapy achieved a 60% complete response rate in high-risk frontline AML patients, significantly exceeding typical outcomes and maintaining a strong safety profile.

AML3D has maintained a steady $2.2 million quarterly revenue run rate and secured $12.5 million in new orders during 3Q26, pushing its total orders for FY2026 to $29 million. The company is aggressively expanding its US manufacturing footprint and making initial inroads into UK and European defence markets.

Gale Pacific reported a $1.3 million operating cash outflow in Q3 FY26 amid Middle East geopolitical tensions but strengthened its net cash position by $18 million year-on-year. The company is executing a revised strategy focused on expanding its US commercial footprint and diversifying manufacturing beyond China.

HITIQ Limited's March quarter saw a remarkable 223% jump in sales to $294k, driven by the nationwide rollout of its PROTEQT™ concussion management system and initial international sales. The company bolstered its governance and advisory ranks while managing funding to support its commercial push.

X2M Connect accelerated revenue growth in Q3 FY26 with a 67% increase, driven by strong demand in South Korea and new Australian smart community deals. The company’s capital raise and expanding customer base underpin its push into new markets despite ongoing cash burn.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Noxopharm’s Sofra™ oligonucleotides, delivered via InhaTarget’s inhalable lipid nanoparticles, achieved a significant reduction in lung inflammation in preclinical models, broadening Sofra’s therapeutic reach and delivery versatility.

Neuren Pharmaceuticals reported a solid A$30.4 million net profit in 2025, powered by a 15% rise in DAYBUE® royalties. The company is progressing its NNZ-2591 Phase 3 trial for Phelan-McDermid syndrome and has initiated a share buy-back amid perceived undervaluation.

Saferoads Holdings maintained steady sales in the March quarter with a positive operating cash flow and ongoing product upgrades, despite cost pressures from oil-based materials and uncertainty over future orders from On-site Rentals.

Hillgrove Resources (ASX:HGO) marked its first full year of underground copper production at Kanmantoo with 11,315 tonnes produced, returning to profitability and significantly boosting its Mineral Resources and Ore Reserves. The company is advancing growth projects and sustainability initiatives to underpin a production ramp-up in 2026.