Latest Clinical Research News

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.

4DMedical delivered sharp growth in scans, sites and operating revenue as CT:VQ moved into commercial deployment across several global markets. But the company remains loss-making and its auditor issued a qualified opinion over the carrying value of goodwill and other intangible assets.

Biome Australia Limited (ASX:BIO) delivered its second consecutive profitable year in FY26, with revenue rising 30% to $23.9 million and operating cash flow turning positive. But the headline $3.6 million profit includes a $2.4 million deferred tax benefit, leaving FY27 execution as the real test of the company’s growth plan.

Alterity Therapeutics posted a 285% jump in revenue to A$1.72 million but also a 93% rise in net loss to A$23.4 million for FY2026. The company secured FDA alignment on a single pivotal Phase 3 trial for ATH434 in Multiple System Atrophy, setting the stage for trial start by year-end.

Nuchev has inked a consignment-based distribution deal to launch the Kuci women’s health probiotic range nationally through Chemist Warehouse, marking a strategic expansion into women’s health.

Resonance Health (ASX: RHT) reported a profitable turnaround in FY26, driven by growth across its imaging software, clinical trial services, and site network businesses.

Percheron Therapeutics has partnered with Vanderbilt Health to initiate a clinical trial testing HMBD-002 in combination with standard treatments for high-risk acute myeloid leukaemia and myelodysplastic syndrome, targeting a recruitment start in late 2026.

NeuroScientific Biopharmaceuticals posted a $4.69 million loss for FY2026, driven by R&D ramp-up and clinical progress with its StemSmart™ platform, while halting independent development of its glaucoma drug EmtinB to pursue licensing deals.

Emyria has expanded its Empax clinic network across four states, reporting a 210% revenue increase in FY26 and early clinical success in treatment-resistant depression.

Biome Australia capped FY26 with record $23.9 million sales and its flagship probiotic topping Australian pharmacy charts. The company signed an onshore manufacturing deal and expanded its proprietary probiotic clinical trial internationally.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.