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neuren pharmaceuticals ltd (NEU) Details

Neuren Pharmaceuticals Limited, a biopharmaceutical company, focuses on the development of therapies for brain injury, neurodevelopment, and neurodegenerative disorders primarily in the United States. Its product development pipeline includes NNZ-2566 that is in Phase II clinical trials in rett syndrome, fragile X syndrome, and moderate to severe traumatic brain injury, as well as in concussion; and NNZ-2591, which is in preclinical development for chronic neurodegenerative conditions. The company has collaborative relationship with the US Army Medical Research & Materiel Command; and the Walter Reed Army Institute of Research. Neuren Pharmaceuticals Limited is based in Camberwell, Australia.

neuren pharmaceuticals ltd (NEU) Top Compensated Officers

Chief Executive Officer, Managing Director, C...
Total Annual Compensation: $493.0K
Executive Chairman
Total Annual Compensation: $512.0K
Compensation as of Fiscal Year 2013.

neuren pharmaceuticals ltd (NEU) Key Developments

Neuren Pharmaceuticals Ltd Submits Applications to the US Food and Drug Administration for Orphan Drug Designation and Breakthrough Therapy Designation for NNZ-2566 Treatment for Rett Syndrome

Neuren Pharmaceuticals Ltd. has submitted applications to the US Food and Drug Administration (FDA) for Orphan Drug designation and Breakthrough Therapy designation for its NNZ-2566 treatment for Rett Syndrome. Orphan Drug designation is a special status that the FDA may grant to a drug to treat a rare disease or condition. It qualifies the sponsor of the drug for seven years of marketing exclusivity and various development incentives including waiver of the prescription drug user fee for a marketing application. The FDA has previously granted Orphan Drug designation to Neuren for NNZ-2566 in Fragile X syndrome. The company is well funded with cash reserves of about 21 million. It expects to meet with the FDA in the first half of 2015 to discuss the remaining requirements for the development of NNZ-2566 in Rett syndrome. To date 22 subjects have commenced treatment in Neuren’s Phase 2 trial of NNZ-2566 in Fragile X syndrome 19 of which have already completed. The trial represents a significant commitment for families with only 2 subjects entering the trial during the U.S. holiday period in November and December. Neuren is taking a number of steps to accelerate enrolment into the trial including working closely with advocacy organizations to ensure that the recent results of the trial of NNZ-2566 in Rett syndrome are widely communicated. The number of trial sites enrolling will increase from 6 to 9 in January 2015 and further sites will be added to expand the geographical coverage in the United States. Neuren is also currently investigating the feasibility of extending the trial to include sites in Australia Top-line results from the trial that were targeted for the second quarter of 2015 are now expected in the second half of 2015.

Neuren Pharmaceuticals Announces Results from its US Phase 2 Clinical Trial in Rett Syndrome

Neuren Pharmaceuticals announced results from its US Phase 2 clinical trial in Rett syndrome, which successfully demonstrated clinical benefit from treatment with NNZ-2566. Neuren intends to submit applications to the US Food and Drug Administration (FDA) for both Orphan Drug and Breakthrough Therapy designation. Neuren expects to meet with the FDA in the first quarter of 2015 to discuss the trial results and the requirements for the further development of NNZ-2566 in Rett syndrome. There are currently no approved medicines for the treatment of Rett syndrome, which is a severe neurological disorder caused by mutations of the MECP2 gene on the X chromosome. The disorder has an onset in early childhood and is often progressive into adolescence and adulthood. Neuren's trial was conducted at Baylor College of Medicine (Daniel Glaze, MD, and Jeffrey Neul, MD), University of Alabama at Birmingham (Alan Percy, MD) and Gillette Children's Specialty Healthcare (Tim Feyma, MD, and Art Beisang, MD). This was the first multi-site, sponsor-led clinical trial in Rett syndrome and was the first trial in an adolescent and adult population.

Neuren Pharmaceuticals Limited Reports Unaudited Earnings Results for the Six Months Ended June 30, 2014

Neuren Pharmaceuticals Limited reported unaudited earnings results for the six months ended June 30, 2014. For the period, the company reported revenue – interest income of AUD 0.303 million compared to AUD 0.046 million a year ago. Loss before income tax was AUD 4.671 million compared to AUD 3.089 million a year ago. Loss after tax attributable to equity holders of the company was of AUD 4.656 million or 0.3 cents per basic and diluted share compared to AUD 3.062 million or 0.3 cents per basic and diluted share a year ago. Net cash used in operating activities was AUD 2.598 million compared to AUD 2.417 million a year ago. Purchase of property, plant and equipment was of AUD 0.020 million compared to AUD 0.003 million a year ago.


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