Latest Clinical Data News

CurveBeam AI reported stable device orders but faces regulatory delays for FDA and China clearances, while securing a A$4 million investment from WEGO Orthopaedics and advancing clinical collaborations with robotic surgery systems.

Nova Eye Medical reported a 23% rise in quarterly sales to US$5.8 million, driven by strong US growth and initial Chinese sales. EBITDA loss narrowed significantly, with positive operational EBITDA recorded.

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.

Orthocell’s latest Remplir™ Real World Evidence study reveals an 89.7% treatment success rate across 78 nerve repair procedures, reinforcing its clinical strength and fueling US and European market growth plans.

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.

Cleo Diagnostics has kicked off a staged manufacturing program with Bio-Techne to produce ovarian cancer test kits, moving from clinical sample collection to analytical validation and FDA submission preparation.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.

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.

Biome Australia has taken a significant step in its innovation journey by filing a patent for its next generation probiotic strain BMB18, with a clinical trial set to begin in Q4 FY26 in partnership with La Trobe University.

CLINUVEL Pharmaceuticals has received final scientific advice from the European Medicines Agency on the design of its pivotal Phase III trial for SCENESSE in vitiligo, endorsing a comprehensive evidence approach and prioritising patients with darker skin tones.