Latest Biotechnology News

Tissue Repair advances its US Phase III chronic wound trial with 100 patients randomised and targets October FDA 510(k) submission. The company reports a robust cash position bolstered by R&D refunds and has cut manufacturing scale-up costs.

Skin Elements has secured an exclusive New Zealand distribution agreement for its ECO-Nurture bio-stimulant, raised $1.47 million through options and placement, and refreshed its board after shareholder votes.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial stays on track for November topline results, buoyed by strong open-label extension enrolment and aligned EMA-FDA regulatory advice. A new antidepressant study publication and fresh patents add momentum, supported by a $16.7 million cash runway to mid-2027.

Mesoblast delivered US$115 million in Ryoncil® revenue in its first full year post-FDA approval, while expanding clinical trials into adult indications and acquiring cutting-edge CAR technology to boost its cell therapy pipeline.

Alterity Therapeutics has cleared a major regulatory hurdle with the FDA endorsing a single pivotal Phase 3 trial for its ATH434 drug in Multiple System Atrophy, setting the stage for trial initiation by the end of 2026.

Dimerix Limited (ASX: DXB) has inked its fifth regional licensing agreement with Everest Medicines, boosting potential milestone payments to A$1.9 billion and expanded its kidney disease pipeline through the acquisition of DMX-652. The Phase 3 ACTION3 trial for DMX-200 remains statistically robust, with funding secured to advance both clinical programs.

Avecho Biotechnology has secured a unanimous recommendation to continue its Phase III insomnia trial without increasing sample size, alongside raising $1.9 million through option exercises and bolstering its cash position to $6.6 million.

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

ReNerve Limited delivered its strongest sales quarter ever with $211,000 in revenue, boosted by new distribution deals in Asia-Pacific and a $5 million funding facility to underpin growth.

AdAlta has completed a key US$1 million milestone payment securing rights to its lead CAR-T therapy EW-001 outside Greater China, progressed Australian manufacturing with first runs expected late 2026, and is preparing for a critical pre-IND meeting with the US FDA.

PYC Therapeutics has made significant progress across its four RNA therapeutic programs, including dose escalation approvals in its Polycystic Kidney Disease trial and orphan drug designation for its Retinitis Pigmentosa candidate, supported by a robust cash position of $669 million.

Biome Australia capped FY26 with record $23.9 million sales and its flagship probiotic topping Australian pharmacy charts. The company signed an onshore manufacturing deal and expanded its proprietary probiotic clinical trial internationally.