Latest Biotechnology News

AdAlta has secured Australian manufacturing for its lead CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients. This move is a key step toward local clinical trials and boosts the therapy’s global commercial appeal.

Argenica Therapeutics is progressing its ARG-007 drug toward a targeted Phase 2b trial for acute ischaemic stroke, leveraging AI for patient selection and securing key regulatory approvals, while maintaining a solid cash position of $8 million.

Amplia Therapeutics reported mature ACCENT trial data showing improved survival and multiple complete responses with narmafotinib, alongside a GMP production milestone and CFO appointment.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

Entropy Neurodynamics has reported encouraging early clinical outcomes from its pioneering intravenous psilocin therapy for Binge Eating Disorder, alongside a patent grant that strengthens its intellectual property moat.

PYC Therapeutics fortified its balance sheet by $600 million and progressed key RNA therapeutic trials in Q1 2026, setting the stage for pivotal clinical data and regulatory submissions.

Cambium Bio has clinched FDA agreement on a streamlined single pivotal Phase 3 trial for Elate Ocular®, cutting development complexity, while bolstering its cash position through a A$2.4 million strategic placement by major shareholder ZYBT.

INOVIQ Limited is on track to complete its EXO-OC™ ovarian cancer screening study by mid-2026 and is accelerating its CAR-exosome therapy program, supported by a strong cash position of A$11.9 million.

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

Paradigm Biopharmaceuticals has upsized a $14 million placement and launched a $2 million SPP, boosting its cash runway to around $45 million. This capital injection supports the ongoing Phase 3 trial for knee osteoarthritis, with interim results expected in Q3 2026.

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

Chimeric Therapeutics' CHM CORE-NK cell therapy achieved a 60% complete response rate in high-risk frontline AML patients, significantly exceeding typical outcomes and maintaining a strong safety profile.