Latest Regulatory Engagement News

Anteris Technologies Global Corp. reported a $42.7 million net loss for the first half of 2025 amid advancing preparations for its pivotal DurAVR Transcatheter Heart Valve trial. The company’s recent IPO proceeds are fueling R&D and manufacturing scale-up as it targets regulatory approvals.

Immutep has received encouraging feedback from the FDA on its immunotherapy eftilagimod alfa combined with KEYTRUDA for patients with low PD-L1 expression in head and neck cancer, opening potential accelerated approval pathways.

TPG Telecom has completed its transformative Vocus acquisition, launching a $4.7 billion capital management plan that includes a $3 billion shareholder return, significant debt repayment, and strong FY25 financial guidance.

Race Oncology’s Phase 1b/2 trial of RC110 bisantrene for relapsed or refractory acute myeloid leukemia has demonstrated a 40% response rate, exceeding expectations and offering new hope for difficult-to-treat patients.

Bridge SaaS Limited reports steady cash flow and strategic focus on AI and robotics to transform disability care under the NDIS framework.

Pacific Lime and Cement Limited has made significant strides in Papua New Guinea, rebranding and advancing key projects while initiating commercial quicklime shipments to Western Australia. The company’s robust cash position and community agreements set the stage for upcoming construction milestones.

Argent BioPharma has achieved a significant milestone by commencing formal supply of its EU-GMP cannabinoid API for epilepsy treatment at a leading Slovenian hospital and gaining prescription approval for CannEpil™ in Germany, marking key steps in its European expansion.

Echelon Resources finalised its EP145 acquisition and reported a slight dip in production volumes, while Amadeus Basin receipts surged 24% thanks to new wells. The company maintains a strong cash position and is actively reshaping its portfolio for future growth.

Southern Palladium has secured Environmental Authorisation for its Bengwenyama PGM project, completed an optimised Pre-Feasibility Study showing robust economics, and raised A$8 million to fund next-stage development.

Neurizon Therapeutics has made significant strides in developing its lead ALS drug candidate NUZ-001, unveiling a new liquid formulation and submitting a key regulatory response to the FDA. Clinical and preclinical data bolster hopes for broader neurodegenerative applications.

Bastion Mining has taken control of over 90% of Xanadu Mines shares through a takeover bid, moving swiftly to compulsory acquisition and setting the stage for the Kharmagtai project’s next phase.

NuEnergy Gas Limited has completed drilling two wells at its Tanjung Enim PSC in Indonesia, advancing its early gas sales initiative targeting 1 million cubic feet per day. The company is finalizing a major gas sales agreement pending government approval.