Latest Biotechnology News

Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.

Immutep’s novel immunotherapy combination with KEYTRUDA and chemotherapy shows a 60.8% response rate in first-line non-small cell lung cancer, outperforming historical benchmarks especially in patients with low PD-L1 expression.

Genetic Technologies Limited has officially exited external administration following the effectuation of a Deed of Company Arrangement, marking a significant shift in its corporate governance and creditor relations.

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

PolyNovo’s NovoSorb BTM technology has demonstrated promising first-in-human results as a novel delivery platform for pancreatic islet cell transplants in Type 1 diabetes, potentially redefining treatment approaches.

Holista Colltech Limited has responded to an ASX price query regarding recent unusual trading activity, confirming no undisclosed material information exists to explain the surge.

Bio-Gene Technology Limited has launched a Share Purchase Plan allowing Australian shareholders to invest up to $15,000 at 2.3 cents per share, matching a recent $2.1 million placement. The offer includes free-attaching options, subject to shareholder approval, to support key product development milestones.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Nyrada’s experimental drug NYR-BI03 shows promising cardioprotective and anti-arrhythmic effects in animal models, reinforcing its potential as a treatment for acute myocardial infarction.

Memphasys Limited has successfully trialed its RoXsta™ Mega Cell High-Throughput Assay, capable of processing 96 antioxidant tests in under an hour, promising a leap forward in rapid, cost-effective oxidative stress analysis.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.

AdAlta Limited has announced a pro rata renounceable rights offer to raise approximately $1.29 million, aiming to fund its strategic pivot towards licensing CAR-T cell therapies through its subsidiary AdCella. The offer includes new shares and options, underpinned by key insiders and an underwriting agreement.