Latest Biomarkers News

The FDA says positive results from Neurizon’s HEALEY ALS trial could potentially support traditional approval of NUZ-001, with the study possibly serving as the sole registrational trial. The guidance is conditional, but gives the company a clearer regulatory route ahead of topline results expected in late Q2 2027.

CONNEQT Health delivered sharp FY26 revenue growth and reduced its statutory loss as Pulse sales and clinical subscriptions expanded. But the ASX-listed medtech group ended the year with negative net assets, heavy cash burn and a material uncertainty over its ability to continue as a going concern.

TrivarX has made Stabl-Im its central development bet, but the ASX-listed health technology company also reported an $8.76 million FY2026 loss and an auditor-flagged material uncertainty over its ability to continue without further funding. The planned Phase 1 study remains subject to regulatory, ethics and operational clearances.

Cleo Diagnostics has begun developing a multi-biomarker blood test for ovarian cancer screening in asymptomatic women, targeting a stated $150 billion global market. The prototype program will run alongside the company’s pre-surgical test, with initial proof-of-concept data expected early next quarter.

Actinogen Medical has completed the final patient visit in its 247-participant XanaMIA Alzheimer’s disease trial, keeping topline results on track for November 2026. The milestone closes patient participation in the pivotal study, but provides no indication yet of whether Xanamem improved outcomes.

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.

Nyrada has secured AU$12.0 million from institutional and sophisticated investors, with a further AU$2.0 million shareholder purchase plan planned, giving the biotech funding to advance its Xolatryp clinical programs. The raise also carries substantial dilution and an unusually large proposed director subscription worth AU$5.125 million, subject to shareholder approval.

Entropy Neurodynamics reported that all six patients in Cohort 1 of its Phase 2 BED trial maintained clinically meaningful improvement 12 weeks after two TRP-8803 infusions. Three patients experienced no binge-eating episodes during the 84-day follow-up, although the results come from a small, open-label study without a control group.

A multimillion-dollar, multiyear NIH grant will fund an expanded access program for Neurizon’s investigational NUZ-001, potentially giving up to 200 US patients access to the therapy for as long as 96 weeks. The program is designed to add long-term safety, survival and biomarker data alongside the pivotal HEALEY ALS trial.

Actinogen Medical (ASX:ACW) has clarified that no undisclosed information explains recent unusual trading in its shares, pointing instead to recent underwriting of options and published updates. The biotech also reaffirmed compliance with ASX rules and provided a detailed update on its lead Alzheimer’s drug Xanamem and ongoing clinical trials.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

Actinogen Medical has locked in full underwriting for nearly 127 million unlisted options, guaranteeing $4.77 million in fresh funding as it approaches pivotal Alzheimer’s trial results due in November.