Latest Neurodevelopmental Disorders News

Neurotech International has received Notices of Allowance from the USPTO for two patents covering its lead drug NTI164, reinforcing its intellectual property position as it advances Phase 3 trials for autism spectrum disorder.

Neuren’s partner Acadia secures positive CHMP opinion for DAYBU® in Rett syndrome, paving the way for first EU treatment approval and triggering significant milestone payments for Neuren.

Neuren Pharmaceuticals reported a 15% rise in 2025 royalties from DAYBUE®, boosted by strong US sales and a new powder formulation launch. The company is progressing its pivotal Phase 3 trial for NNZ-2591 in Phelan-McDermid syndrome and reassessing capital management amid solid cash reserves.

Neuren Pharmaceuticals saw a 20% jump in Q1 2026 DAYBUE net sales to US$101 million, with royalties up 23%. The Japan trofinetide trial has been fast-tracked, and the new powder formulation DAYBUE STIX gains early traction.

Neurotech International has opened its first Phase 3 clinical site for NTI164 targeting Autism Spectrum Disorder, reported positive 90-day toxicology results, and launched a new Rett syndrome research collaboration.

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.

Neuren Pharmaceuticals reported a solid A$30.4 million net profit in 2025, powered by a 15% rise in DAYBUE® royalties. The company is progressing its NNZ-2591 Phase 3 trial for Phelan-McDermid syndrome and has initiated a share buy-back amid perceived undervaluation.

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

BlinkLab has completed onboarding its tenth and final clinical site for its pivotal FDA 510(k) trial of an AI-powered autism diagnostic aid, setting the stage for patient enrolment to begin this month.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals is seeking a re-examination of the European Medicines Agency’s refusal to approve trofinetide for Rett syndrome, aiming to overturn the setback and bring the treatment to European patients.

Neuren Pharmaceuticals reports a 15% rise in 2025 royalties from its partner Acadia’s DAYBUE sales, with strong 2026 guidance signalling further growth. The launch of a new powder formulation and ongoing regulatory efforts in Europe and Japan add to the momentum.