Latest Biotech News

Paradigm Biopharmaceuticals has secured ethics approval and appointed a CRO to launch its global phase 3 trial for injectable Pentosan Polysulfate Sodium in knee osteoarthritis, while initiating a substantial capital raising program.

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.

Neurizon Therapeutics reported a sharp rise in half-year losses to $7.28 million but marked significant progress with its lead drug NUZ-001 entering a major ALS clinical trial and securing critical regulatory designations.

PYC Therapeutics is set to raise up to $146 million through a pro-rata entitlement offer, aiming to accelerate its RNA-based drug candidates targeting major unmet medical needs. Major shareholder support and underwriting commitments underpin the capital raise.

Neurizon Therapeutics received FDA guidance on its IND application for NUZ-001, with a single request for additional animal exposure data but no safety concerns flagged. The company is actively addressing the FDA’s request while evaluating impacts on its ALS trial timeline.

Avecho Biotechnology has responded to an ASX price query, confirming no undisclosed information exists to explain recent trading spikes, while highlighting market speculation linked to its Phase III CBD insomnia trial.

Recce Pharmaceuticals has temporarily paused trading of its securities, signaling a potentially significant development pending further disclosure.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.

Arovella Therapeutics has requested a voluntary suspension of its ASX-listed securities pending a material announcement on a capital raising, expected by 17 February 2025.

BTC Health has transformed its decade-long license agreement with Arna Pharma into an indefinite partnership, gaining royalties from Singapore and Malaysia sales and first rights to new pharmaceutical products in Australia and New Zealand.

Nyrada has secured ethics approval to begin its first-in-human Phase Ia trial of NYR-BI03, a promising neuro- and cardioprotective drug candidate. Recruitment starts soon, with dosing expected by March and results due in Q3 2025.

Invex Therapeutics reports a significant reduction in net loss for H1 FY2025 alongside promising pre-clinical data for Exenatide in Alzheimer’s Disease models.