Latest Biotechnology News

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.

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.

Vitrafy Life Sciences reported a breakthrough 94.4% post-thaw platelet recovery in US Army Phase II testing, secured major US blood network partnerships, and raised $32 million to accelerate US expansion and device manufacturing.

NeuroScientific Biopharmaceuticals achieved an 80% clinical response rate in fistulising Crohn’s disease patients treated under the TGA Special Access Scheme, advancing plans for Phase 2 trials and manufacturing scale-up.

Microba Life Sciences has wrapped up a $5.41 million capital raise combining a $5 million institutional Placement and a $407,500 Share Purchase Plan, strengthening its balance sheet to accelerate growth in Australia and the UK.

Racura Oncology has hit key clinical milestones in its RC220 development, including first patient dosing in a lung cancer trial and dose escalation in a cardioprotection study, supported by a strong $34.3 million cash position.