Latest Clinical Data News

Rhythm Biosciences has completed critical validation of its ColoSTAT colorectal cancer assay and submitted it for ISO15189 accreditation, paving the way for commercialisation. The test demonstrated strong clinical performance, highlighting its potential as a non-invasive diagnostic tool.

Imugene Limited reported a significant 54% reduction in net loss for FY25, driven by cost efficiencies and promising clinical progress in its immuno-oncology pipeline. The company’s lead asset, azer-cel, achieved a 79% response rate in Phase 1b trials and secured FDA Fast Track designation.

Amplia Therapeutics has successfully raised A$2.65 million through its Share Purchase Plan, exceeding expectations and bolstering funding for pivotal clinical trials of its lead drug narmafotinib.

Actinogen Medical reports steady progress in its Alzheimer’s and depression drug trials, backed by strong funding and strategic commercial planning. Key interim data from the pivotal XanaMIA trial is expected early next year.

LTR Pharma’s intranasal ED treatment SPONTAN achieves peak effect up to five times faster than oral tablets, according to new peer-reviewed clinical data published in a leading European journal.

Argent BioPharma has signed a binding term sheet to acquire key assets from AusCann Group Holdings, significantly expanding its clinical pipeline, intellectual property, and European manufacturing and distribution capabilities ahead of a planned US stock exchange listing.

AdAlta Limited outlines its innovative 'East to West' cellular immunotherapy approach, in-licensing Asian CAR-T assets and progressing clinical trials in Australia to unlock value. The company also seeks partners for its anti-fibrotic and anti-malarial protein therapeutics.

ReNerve Limited has achieved a key milestone with its first sale and clinical use of a deep dermal tissue product in the US, broadening its surgical applications beyond nerve repair. This move complements its existing nerve repair portfolio and sets the stage for further product launches later this year.

Rhythm Biosciences is raising up to $3.75 million through a share placement to fund the launch of its ColoSTAT® colorectal cancer diagnostic and accelerate commercialization of its geneType™ portfolio.

Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.

Syntara Limited has received FDA guidance recommending a Phase 2 controlled trial for its lead drug amsulostat in myelofibrosis, setting the stage for a pivotal Phase 3 study. The company is poised to refine its clinical strategy while advancing a diverse pipeline with key data milestones ahead.

Neuren Pharmaceuticals has added SYNGAP1-related disorder to its NNZ-2591 development program following encouraging pre-clinical findings, targeting a rare condition with no approved treatments.