Latest Biotechnology News

Cambium Bio has secured FDA clearance to begin Phase 3 dosing of Elate Ocular, a promising treatment for moderate to severe dry eye disease, pending additional financing.

Neurizon Therapeutics has received positive feedback from the FDA on its plan to resolve the clinical hold on its ALS drug candidate NUZ-001, with key preclinical studies completed ahead of schedule. The company aims to resume clinical trials in late 2025.

Biome Australia Limited has confirmed its record FY25 sales revenue of approximately $18.4 million, marking a 41% increase year-on-year, while affirming full compliance with ASX continuous disclosure rules.

Anatara Lifesciences has strengthened its intellectual property portfolio with a Japanese patent for its GaRP gastrointestinal health product, while progressing pre-clinical studies in its Anti-Obesity Project. The company also confirmed registration of its R&D Tax Incentive application for 2024-2025.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its PYC-003 clinical trial and will soon begin dosing patients with Polycystic Kidney Disease, marking a pivotal step forward.

Imugene Limited has received a $5.87 million R&D tax refund, reinforcing its capacity to advance clinical trials in immuno-oncology. This funding milestone supports the development of its innovative cancer therapies, including CAR T cell treatments and oncolytic virotherapy.

BCAL Diagnostics has secured a strategic partnership with Cancer Care Associates to fast-track the clinical adoption and revenue generation of its innovative BREASTEST plus™ breast cancer blood test starting FY2026.

Prescient Therapeutics has opened a Share Purchase Plan to raise up to $7 million, offering shareholders discounted shares to fund the Phase 2 development of its targeted cancer therapy PTX-100.

Neurizon Therapeutics has inked a pivotal global licensing deal with Elanco Animal Health, unlocking critical intellectual property and data to accelerate the development and commercialisation of its lead drug candidate NUZ-001 for neurodegenerative diseases including ALS.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

Prescient Therapeutics has launched a $7 million Share Purchase Plan at a notable discount to fund the next phase of clinical trials for its promising PTX-100 cancer therapy. The capital raise aims to accelerate progress toward regulatory approval and patient access.

Biome Australia has reported record-breaking sales revenue for FY25, driven by strong domestic demand and promising international expansion. The company is on track to deliver its first full-year net profit and meet ambitious growth targets.