Latest Regulatory Pathways News

Invion Limited secures a pivotal FDA Orphan Drug Designation for its lead candidate INV043, targeting anal cancer with promising preclinical results and a fast-tracked development path.

AdAlta Limited outlines its innovative 'East to West' cellular immunotherapy approach, in-licensing Asian CAR-T assets and progressing clinical trials in Australia to unlock value. The company also seeks partners for its anti-fibrotic and anti-malarial protein therapeutics.

Rhythm Biosciences has launched a $3.75 million placement alongside an offer of over 52 million new options, all contingent on shareholder approval. The move aims to bolster working capital as the company advances its cancer diagnostic products.

Energy Transition Minerals Ltd has issued over 238 million shares to OCJ Investment and updated its Share Purchase Plan timetable to raise up to $3 million, signaling a strategic capital boost.

Green Technology Metals has achieved a major regulatory milestone by securing full mining lease coverage for its Seymour Lithium Project in Ontario, significantly advancing the project toward construction readiness.

PYC Therapeutics has escalated dosing to the highest level in its Phase 1a trial of PYC-003 and begun dosing patients with Polycystic Kidney Disease, marking key progress toward regulatory milestones.

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.

EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.

Medallion Metals has executed a binding agreement to acquire the Forrestania Nickel Operation from IGO Limited, setting the stage for a low-capital pathway to gold and copper production at its Ravensthorpe project. The transaction targets completion and a final investment decision by late 2025.

4DMedical reports a 56% revenue surge in FY25 alongside a strategic $10 million investment from Pro Medicus, advancing its CT, VQ™ lung imaging technology towards FDA clearance.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Superior Resources Limited has expanded its copper exploration strategy to include high-grade copper-gold targets alongside porphyry prospects, while progressing the Steam Engine Gold Project towards early production within two years.