Latest Clinical Data News

Alterity Therapeutics has secured U.S. FDA Fast Track designation for its drug ATH434 targeting Multiple System Atrophy, supported by promising Phase 2 clinical trial data showing slowed disease progression and a solid safety profile.

Syntara Limited reports encouraging Phase 2 data for its lead drug amsulostat in myelofibrosis, secures FDA Fast Track status, and expands clinical programs into myelodysplastic syndrome and keloid scars.

Paradigm Biopharmaceuticals has advanced its global Phase 3 trial for knee osteoarthritis pain with active patient recruitment in Australia and the US, backed by a $41.2 million convertible note facility. The company also expanded its osteoarthritis portfolio through the acquisition of Proteobioactives and the Pentacoxib™ oral therapy.

SomnoMed reports a robust Q4 FY25 with 25% revenue growth and a milestone of treating over 1 million patients, while gearing up for significant capacity expansion and clinical advancements.

NeuroScientific Biopharmaceuticals has completed its acquisition of StemSmart technology, reporting promising clinical results in Crohn’s disease and GVHD, alongside a $3.5 million capital raise to fuel next-stage development.

AdAlta Limited has prioritized two promising CAR-T cellular immunotherapy products for licensing agreements and successfully raised $1.3 million to support its strategic expansion. The company’s focused capital management and pipeline refinement signal a pivotal phase in its ‘East to West’ strategy.

Argenica Therapeutics has dosed the final patient in its Phase 2 trial for ARG-007 in acute ischaemic stroke, with topline results expected in Q3 2025. Meanwhile, the FDA has placed a clinical hold on its US trial application, introducing uncertainty for US development.

Race Oncology has safely treated the first patient with its RC220 drug alone and in combination with doxorubicin in a Phase 1 trial, while bolstering its clinical leadership and maintaining a strong cash position to fund operations through 2026.

Microba Life Sciences reports record Q4 FY25 microbiome test sales in Australia and the UK, underpinned by landmark clinical studies and a $14.5 million capital raise. The company is transitioning away from legacy products to focus on high-value diagnostics, positioning for sustained growth in FY26.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.

PYC Therapeutics reports solid progress across its four RNA therapeutic programs targeting genetic diseases, backed by a strong cash position extending runway beyond 2027.