NEUREN PHARMACEUTICALS LIMITED overview

Neuren Phase 2 trial shows significant improvements in Pitt Hopkins syndrome PR Newswire MELBOURNE, Australia, May 27, 2024 Highlights: Statistically significant improvement from baseline assessed by both clinicians and caregivers in all four efficacy measures specifically designed for Pitt Hopkins syndrome (Wilcoxon signed rank test p<0.05) Clinician and caregiver global efficacy measures showed a level of improvement considered clinically meaningful: - Clinical Global Impression of Improvement...

Neuren Phase 2 trial shows significant improvements in Phelan-McDermid syndrome PR Newswire MELBOURNE, Australia, Dec. 18, 2023 Highlights: Significant improvement was assessed by both clinicians and caregivers across multiple efficacy measures Improvements were consistently seen across clinically important aspects of Phelan-McDermid syndrome, including communication, behaviour, cognition/learning and socialisation Clinician and caregiver global efficacy measures showed a level of improvement...

Positive FDA meetings enable Neuren to proceed with INDs for three Phase 2 trials PR Newswire MELBOURNE, Australia, June 1, 2021 Highlights: Clear and constructive guidance received from pre-IND meetings with the FDA Office of Neuroscience for Phase 2 clinical trials of NNZ-2591 in Phelan-McDermid, Angelman and Pitt Hopkins syndromes Positive outcome is an important milestone that enables Neuren to proceed with IND applications for FDA clearance to start the trials Subject to IND clearance,...

Neuren Pharmaceuticals (ASX: NEU) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Neuren’s NNZ-2591 for the treatment of Angelman syndrome, Phelan-McDermid syndrome and Pitt Hopkins syndrome. Neuren Executive Chairman Richard Treagus commented: “Orphan Drug Designation is an important commercial milestone which adds significant value and momentum in respect of our plans to move NNZ-2591 into clinical trials in 2020. This confirms that...

MELBOURNE, Australia, March 24, 2017 (GLOBE NEWSWIRE) -- Neuren Pharmaceuticals (NEU.AX) has reported top-line results for its Phase 2 clinical trial in girls with Rett syndrome aged 5 to 15. Rett syndrome is a serious and life threatening condition caused by a gene mutation, for which there are currently no approved treatments. Neuren’s trial was a double-blind, randomized, placebo controlled study conducted in 82 subjects at 12 sites in the United States, led by clinicians experienced in the...