Latest Regulatory Pathways News

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.

Imugene has secured FDA backing to advance its allogeneic CAR T therapy, azer-cel, into a pivotal Phase 3 trial targeting difficult-to-treat diffuse large B-cell lymphoma (DLBCL), including patients relapsed after prior CAR-T treatment.

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

InhaleRx has boosted its funding facility by $12.6 million to accelerate clinical trials of SRX-25, a novel oral treatment for Treatment-Resistant Depression. This brings total available capital to $52.3 million, positioning the company for pivotal Phase III studies.

Patriot Resources advances its Gorman Lithium Project in Ontario, securing drill permits and confirming a high-grade lithium system within a proven strategic district.

LTR Pharma has secured ethics approval for its Phase II SPONTAN clinical trial, focusing on pharmacokinetics and dosing in men aged 65 and older. Recruitment begins early 2026 with initial results expected mid-year.

Nexsen Limited has appointed internationally acclaimed surgeon-scientist Professor Shekhar Kumta to its board, aiming to fast-track clinical validation and regulatory approval for its rapid diagnostic platforms ahead of a planned 2026 market entry.

Island Pharmaceuticals has secured over $1 million through option exercises by directors and major shareholders, bolstering its cash reserves to advance the clinical and regulatory development of its broad-spectrum antiviral, Galidesivir.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.

Amplia Therapeutics reported a $4.18 million half-year loss but bolstered its cash reserves with a $27.6 million capital raise to advance clinical trials of its lead drug narmafotinib, showing encouraging interim data in pancreatic cancer.

The Federal Court of Australia has approved the acquisition scheme for Lynch Group Holdings, paving the way for a cash payout to shareholders and imminent trading suspension.