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Neurotech Wins Ethics Approval for Pivotal Phase 3 Autism Trial of NTI164

Story Highlights
  • Neurotech received ethics approval to launch its pivotal Phase 3 Beyond Harmony trial of NTI164 in autism spectrum disorder Levels 2 and 3.
  • The Phase 3 study is designed to support Australian and US registrations, leveraging strong prior NTI164 data to advance Neurotech’s commercialisation strategy.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Neurotech Wins Ethics Approval for Pivotal Phase 3 Autism Trial of NTI164

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The latest announcement is out from Neurotech International ( (AU:NTI) ).

Neurotech International has secured Human Research Ethics Committee approval to begin its Beyond Harmony Phase 3 clinical study of NTI164 in individuals with autism spectrum disorder Levels 2 and 3, a pivotal step in its strategy to commercialise the cannabinoid-based therapy for paediatric neurological conditions. The trial, designed using robust data from earlier ASD studies showing clinically meaningful symptom and quality-of-life improvements, aims to generate registration-ready evidence for regulators in Australia and the United States, strengthening Neurotech’s pathway toward market authorisation, expanding its clinical footprint in both regions, and potentially enhancing its positioning in the emerging neurodevelopmental therapeutics market.

The most recent analyst rating on (AU:NTI) stock is a Sell with a A$0.01 price target. To see the full list of analyst forecasts on Neurotech International stock, see the AU:NTI Stock Forecast page.

More about Neurotech International

Neurotech International is a clinical-stage biopharmaceutical company focused on paediatric neurological disorders, developing its broad-spectrum oral cannabinoid therapy NTI164. The company has reported statistically significant, clinically meaningful results and strong safety from prior Phase I/II and Phase II/III trials in autism spectrum disorder, PANDAS/PANS and Rett syndrome, and is also advancing NTI164 into clinical testing for spastic cerebral palsy.

Average Trading Volume: 941,704

Technical Sentiment Signal: Sell

Current Market Cap: A$16.85M

Learn more about NTI stock on TipRanks’ Stock Analysis page.

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