Latest NEU News

Healthcare stocks split into two stories this week: big names sold off hard, while a few small caps ran on clear news. The biggest moves came from a sharp fall in Pro Medicus and Cochlear, while Noxopharm jumped after a top-tier journal publication.

Neuren Pharmaceuticals has initiated a discretionary on-market share buy-back program of up to 5%, citing a strong cash position and undervaluation relative to internal and analyst assessments.

A single diagnostics update sparked a breakout week, while a handful of biotech names sold off hard despite busy newsflow. Capital raisings, takeover steps and US market pushes kept healthcare in motion heading into mid-February milestones.

Neuren Pharmaceuticals has dosed the first patient in its groundbreaking Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome, a rare genetic disorder with no approved therapies. The trial marks a significant step forward for the PMS community and rare disease drug development.

The US Congress has reauthorized the Rare Pediatric Disease Priority Review Voucher program through September 2029, a move that could significantly benefit Neuren Pharmaceuticals as it advances its rare disease drug candidates.

Neuren Pharmaceuticals has received detailed feedback from the US FDA on its clinical development plans for NNZ-2591 targeting hypoxic ischemic encephalopathy and Pitt Hopkins syndrome, paving a clearer path forward despite some delays.

Acadia Pharmaceuticals has received a negative vote from the European Medicines Agency’s committee on its application to market trofinetide for Rett syndrome in the EU, prompting plans for a re-examination request.

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.

Neuren Pharmaceuticals’ partner Acadia projects DAYBUE sales to reach around US$700 million by 2028, driven by US market expansion and international approvals. The launch of a new formulation and ongoing clinical trials in Japan underpin this optimistic outlook.

Neuren Pharmaceuticals has published promising Phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, underpinning its ongoing Phase 3 Koala trial recruiting in the US.

Neuren Pharmaceuticals has secured Health Canada approval to expand its pivotal Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome into Canadian sites, complementing ongoing US enrolment.