Latest Clinical Development News

Mesoblast Limited reports a 69% jump in net revenues from its pioneering cell therapy Ryoncil in Q1 FY2026, propelled by expanded physician adoption and new reimbursement pathways. The company also secures convertible note funding and plans pivotal adult trials.

AdAlta Limited has raised up to A$1.1 million through a private placement, boosting its war chest to advance innovative cellular immunotherapy projects targeting solid cancers.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

Radiopharm Theranostics has completed a A$35 million institutional placement and launched a A$5 million Share Purchase Plan, both at $0.03 per share, to fund drug manufacturing and clinical trials through 2027.

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

TrivarX Limited has announced the acquisition of Stabl-Im, a novel stable isotope MRI technology for early brain tumor detection, backed by a $4.2 million capital raise including investment from biotech leader Dr Daniel Tillett.

Actinogen Medical has secured an initial $5.5 million R&D tax incentive rebate from the Australian Tax Office, with an additional $1.9 million pending, bolstering funding for its Alzheimer’s and depression drug trials.

Clarity Pharmaceuticals’ Co-PSMA Phase II trial shows its Cu-SAR-bisPSMA diagnostic agent detects more prostate cancer lesions than current standard imaging, promising earlier and more accurate recurrence detection.

PYC Therapeutics has reported encouraging pre-clinical results for its RNA therapy candidate PYC-002 targeting Phelan-McDermid Syndrome, supporting plans to enter human trials in 2026. The data demonstrate safety, brain distribution, and gene expression restoration in key disease regions.

Immutep Limited has confirmed 30 mg as the optimal biological dose for its immunotherapy efti, following FDA approval of Project Optimus requirements. This milestone paves the way for the US launch of its pivotal Phase III lung cancer trial.

Prescient Therapeutics has bolstered its cash reserves to $12.3 million following a $9.8 million capital raise, while progressing its PTX-100 cancer therapy through global Phase 2 trials with encouraging early lymphoma results.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.