Latest Biotechnology News

AdAlta’s subsidiary AdCella has completed its first Joint Development Committee meeting with Shanghai Cell Therapy Group, advancing the development of the CAR-T therapy BZDS1901 with potential timeline acceleration and reduced regulatory risks.

Clarity Pharmaceuticals has signed a significant manufacturing supply agreement with Theragenics to produce copper-64, a key isotope for its upcoming prostate cancer diagnostic, Cu-SAR-bisPSMA. This deal strengthens Clarity’s US supply network ahead of anticipated FDA approval and commercial launch.

Amplia Therapeutics reports a remarkable 7.8% complete response rate and improved survival in its ACCENT pancreatic cancer trial, positioning narmafotinib as a promising new treatment option.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

AdAlta Limited has been granted a key Canadian patent for its anti-fibrotic drug AD-214, completing its composition of matter protection across all major commercial markets. This milestone strengthens the company’s intellectual property portfolio and underpins its commercial strategy for AD-214.

Memphasys Limited confirms uninterrupted operations across the Middle East and North Africa, securing new orders and advancing regulatory approvals despite ongoing regional tensions.

CLINUVEL Pharmaceuticals reports record first-half profits and confirms CEO Philippe Wolgen’s leadership through a pivotal growth phase, prioritising its vitiligo program and Nasdaq ambitions.

Recce Pharmaceuticals is progressing its Phase 3 clinical trial of RECCE 327, a novel synthetic antibiotic targeting multidrug-resistant infections, with interim data from Indonesia supporting registration plans across ASEAN by 2026.

Chimeric Therapeutics Limited has announced a significant 100-to-1 security consolidation affecting shares, options, and performance rights, pending shareholder approval and set for implementation in April 2026.

Immutep Limited has successfully completed the single ascending dose phase of its IMP761 trial, showing promising safety and immunosuppressive effects in healthy volunteers. The biotech’s novel LAG-3 agonist could reshape autoimmune disease treatment.

Biotron Limited reveals that its lead antiviral candidate BIT-HBV001 shows promising activity against Hepatitis Delta Virus, expanding its potential impact beyond Hepatitis B. Meanwhile, the company completes integration of Sedarex and advances regulatory plans for its anaesthetic SedRx.

Imugene Limited has launched a $20 million equity raising comprising a $12 million placement and an $8 million Share Purchase Plan, alongside issuing options, convertible notes, and warrants to support its azer-cel clinical program.