Latest Neurizon 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.

Neurizon will redeem 1 million convertible notes held by Obsidian for US$1.15 million, while securing a two-month standstill on share sales. The biotechnology company says the transaction leaves it funded through the HEALEY ALS trial readout and completion.

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.

Neurizon has appointed Dr Chris Bremer as chief executive as its NUZ-001 ALS program moves towards topline Phase 2/3 results expected in late Q2 2027. The incoming CEO brings more than 20 years of pharmaceutical and biotechnology experience, including over US$1 billion in licensing transactions.

Neurizon Therapeutics has completed enrolment in its pivotal HEALEY ALS Platform Trial ahead of schedule, secured critical manufacturing and funding agreements, and reduced its net loss for FY2026 while preparing for topline results in late Q2 2027.

Neurizon Therapeutics has completed enrolment for Regimen I of its HEALEY ALS Platform Trial in under five months, speeding up topline data release to late Q2 2027 and materially de-risking its lead clinical program.

Neurizon Therapeutics has secured a critical five-year supply agreement with Elanco Animal Health for GMP-grade monepantel, underpinning the commercialisation readiness of its lead ALS drug candidate NUZ-001.

Neurizon Therapeutics has dosed over 50% of participants in the HEALEY ALS Platform Trial's Regimen I, exceeding recruitment expectations after expanding the cohort from 160 to 240 patients. The accelerated pace puts the company on track for last patient dosing in Q2 2027 and topline results by early Q3 2027.

Neurizon Therapeutics has boosted the participant count in its HEALEY ALS Platform Trial Regimen I from 160 to 240, capitalising on faster enrolment and philanthropic support to maintain costs and accelerate topline results to early Q3 2027.

Neurizon Therapeutics has gained ethics approval to start a Phase 1 trial of its NUZ-001 oral liquid formulation, aiming to ease treatment for ALS patients with swallowing difficulties.

Neurizon Therapeutics has secured an additional A$2.7 million through a placement addressing the shortfall from its entitlement offer, lifting total proceeds to approximately A$8.5 million. This fresh capital strengthens the biotech’s balance sheet and provides financial flexibility as it advances its lead ALS drug NUZ-001 through pivotal clinical stages.

Neurizon Therapeutics announces the resignation of CEO Dr Michael Thurn, with Executive Chair Sergio Duchini stepping in temporarily as the company embarks on a global hunt for new leadership.