Latest Biotechnology News

Alterity Therapeutics has responded to an ASX inquiry about its recent share price and volume spike, confirming no undisclosed information but highlighting imminent clinical data releases and investor roadshows as possible drivers.

Nyrada has initiated the last cohort of its Phase I trial for Xolatryp, following a clean safety review of the highest dose tested so far. This step sets the stage for critical data that could shape the drug’s next development phase.

Imugene Limited reports promising Phase 1b trial results for azer-cel, an off-the-shelf CAR T therapy, showing a 75% overall response rate in relapsed diffuse large B-cell lymphoma patients. The company plans to engage the FDA later this year to discuss pivotal trial design.

Bio-Gene Technology Limited has announced an offer of over 95 million Placement Options to investors and its Lead Manager, contingent on shareholder approval at an upcoming extraordinary general meeting. If exercised, these options could inject approximately $3.8 million into the company.

Tissue Repair Limited has secured major distribution partnerships in Australia, New Zealand, and Thailand for its TR Pro+® product line, marking a pivotal shift from development to commercialisation. The company is also scaling up manufacturing and advancing regulatory approvals to support its global expansion ambitions.

Invion Limited’s IVXO securities have been suspended from ASX quotation due to non-compliance with key listing rules, raising questions about the company’s regulatory standing and investor confidence.

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.