Latest Regulatory Updates News

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals is seeking a re-examination of the European Medicines Agency’s refusal to approve trofinetide for Rett syndrome, aiming to overturn the setback and bring the treatment to European patients.

Neuren Pharmaceuticals reports a 15% rise in 2025 royalties from its partner Acadia’s DAYBUE sales, with strong 2026 guidance signalling further growth. The launch of a new powder formulation and ongoing regulatory efforts in Europe and Japan add to the momentum.

NeuroScientific Biopharmaceuticals reported a $1.7 million loss for the half-year ending December 2025, driven by ongoing R&D investments. The company progressed clinical treatments for Crohn’s disease and glaucoma, alongside key leadership appointments and strategic partnerships.

AdAlta Limited reported a $2.44 million loss for H1 FY26 while progressing a key CAR-T therapy collaboration and raising $2.8 million in capital. The company’s ‘East to West’ immunotherapy strategy gains momentum with regulatory tailwinds and cost efficiencies.

Bubs Australia reports a 14% increase in half-year revenue, powered by a 47% jump in US sales, while other regions face challenges. The company remains optimistic about FDA approval and market recovery in H2 FY26.

Cokal Limited has advanced its metallurgical coal operations in Central Kalimantan with new mining contracts, resumed coal shipments, and infrastructure upgrades, aiming for a 2026 production target of approximately 420,000 tonnes.

Cann Group Limited has reported its first-ever free cash flow positive quarter, following a significant debt restructuring and a $9 million capital raise. Despite a softer quarterly revenue, the company is advancing new product launches and export partnerships, positioning itself for growth.

Infinity Metals has completed drilling at its Cobungra Gold-Copper-Silver Project in Victoria, confirming mineralisation over a 2km strike, while awaiting regulatory feedback on its San Jose Lithium Mining Licence Application in Spain.

Bioxyne Limited has posted a record $17.2 million in quarterly revenue for Q2 FY26, driven by strong growth in its cannabis and psychedelics segments alongside strategic international expansions.

Electro Optic Systems (EOS) reports a record $459 million contract backlog, major new defence contracts including a $120 million laser weapon deal, and a strategic acquisition to boost counter-drone capabilities.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

MRG Metals has completed its acquisition of the Garies Rare Earth Project, adding a high-grade, magnet-rich rare earth asset in South Africa to its portfolio. This move significantly boosts the company’s exposure to critical minerals essential for emerging technologies.