Latest Biotechnology News

Immutep’s INSIGHT-003 trial shows promising overall survival in first-line non-squamous NSCLC, yet the Phase III TACTI-004 trial was discontinued following a futility analysis. Ongoing root cause investigations aim to clarify the divergent outcomes.

INOVIQ Limited hit a roadblock in expanding clinical validation of its EXO-OC™ ovarian cancer test due to unsuitable biobank samples, yet improved its diagnostic algorithm and progressed its CAR-exosome therapeutic program, maintaining a solid cash position of A$9.35 million.

Patrys has assigned its deoxymab intellectual property to Yale University in a deal granting it half of all future commercialisation revenue, reducing capital needs while keeping long-term upside.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

Dimerix will provide continued access to its investigational drug DMX-200 for eligible patients with focal segmental glomerular sclerosis after completing the pivotal ACTION3 Phase 3 trial, supporting ongoing treatment ahead of regulatory approval.

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.

Imugene has secured $11.12 million through a placement to advance its allogeneic CAR-T therapy azer-cel after early clinical data showed complete responses in BTKi-resistant lymphoma patients.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

Zoono Group has reported a 94% jump in quarterly cash receipts to NZ$975K, turning cash flow positive amid expanding commercial rollouts of its shelf-life extension technology across multiple continents.

Nexalis Therapeutics has ended funding negotiations with Point8 Capital after failing to secure a formal agreement, while successfully completing its IRX-616a Phase 1 trial with no serious adverse events. The company is reassessing clinical priorities amid funding uncertainty.

ReNerve Limited has secured regulatory approval to market its flagship NervAlign Nerve Cuff in Indonesia, marking a major step in its Asia-Pacific expansion and unlocking access to one of the region’s largest nerve repair markets.