Latest Regulatory Pathways News

Immutep’s combination of eftilagimod alfa (efti) and KEYTRUDA® delivers a striking 17.6-month median overall survival in head and neck cancer patients with low PD-L1 expression, a group with limited treatment options.

Galan Lithium Limited has launched a $4 million Share Purchase Plan for existing shareholders following a $13 million institutional placement, aiming to bolster its capital base at a consistent share price of $0.11.

BlinkLab Limited has raised A$7.66 million through a well-supported placement to accelerate FDA regulatory trials for its autism and ADHD diagnostic platforms, leveraging its innovative smartphone-based technology.

EVE Health Group has executed a binding agreement to acquire Australian biotech Nextract, targeting rapid-onset treatments in the $16 billion global erectile dysfunction and dysmenorrhea markets. The acquisition, supported by a $1.5 million capital raise and share consolidation, marks a strategic shift into regulated pharmaceutical channels.

Lunnon Metals Limited has showcased significant progress in its gold and nickel exploration projects, highlighting strong drilling results and development plans for the Lady Herial gold deposit and Baker-Foster nickel resources.

TrivarX has launched a pivotal mental health clinical trial in partnership with the US Department of Veterans Affairs, leveraging its innovative ECG-based technology to screen for major depressive episodes. The company also secured $2.25 million in funding, positioning it for regulatory milestones ahead.

Actinogen Medical advances its XanaMIA phase 2b/3 Alzheimer’s trial with faster patient enrolment and expands clinical sites, while achieving a pivotal FDA meeting outcome for its depression program. The company maintains a strong cash position, supporting ongoing development and commercialization efforts.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

EMVision Medical Devices has commenced the pivotal clinical trial for its emu™ bedside brain scanner aimed at FDA clearance, while advancing its First Responder device through successful aeromedical testing and ethics approvals. The company maintains strong cash reserves of $12.58 million to support ongoing innovation and clinical activities.

ReNerve Limited reported a 39% sales increase in Q3 FY25 alongside compelling clinical validation of its NervAlign® Nerve Cuff and strategic international partnerships, positioning the company for broader market penetration.

LTR Pharma reports strong Q1 2025 progress with FDA pre-IND meeting success, scientific acclaim for SPONTAN’s rapid absorption, and strategic launch of ROXUS to fast-track US market entry.

Memphasys has initiated clinical utility testing of its Felix™ System in Brazil through a partnership with Laboratorio Androscience, aiming to establish a foothold in the rapidly growing Latin American IVF sector.