prana biotechnology ltd (PRNAF) Key Developments
Prana Biotechnology Limited Receives US Food and Drug Administration Orphan Drug Designation for PBT2 for Huntington Disease
Sep 5 14
Prana Biotechnology Limited has announced the US Food and Drug Administration (FDA) has granted Orphan Drug designation to PBT2 for the treatment of Huntington Disease. Orphan drug designation is granted by the FDA to promote the development of drugs for diseases affecting less than 200,000 people in the United States. Orphan drug designation entitles Prana to seven years of market exclusivity for the use of PBT2 in the treatment of Huntington disease; protocol assistance by the FDA to optimize drug development in the preparation of a dossier that will meet regulatory requirements; and reduced fees associated with applying for market approval. The company will also be applying for Orphan Drug designation in Europe and other jurisdictions. Prana announced in February 2014 that its lead MPAC (Metal Protein Attenuating Compound) PBT2 had met its primary end point of safety and tolerability, and improved measures of cognitive performance - a secondary endpoint in its Reach2HD Phase 2 clinical trial involving 109 people with Huntington disease. Prana is preparing its Post Phase 2 Trial dossier for submission to the FDA to commence discussions on the next development steps for PBT2.
Prana Biotechnology Limited Reports Consolidated Earnings Results for the Year Ended June 30, 2014
Sep 2 14
Prana Biotechnology Limited reported consolidated earnings results for the year ended June 30, 2014. For the period, the company reported revenue from ordinary activities of AUD 363,775 compared to AUD 150,867 a year ago, which is interest received on the group's bank accounts. The company has incurred a loss of AUD 13,329,239 compared to AUD 7,787,242 a year ago. This loss has increased due to an increase in R&D expenditure for the period offset by an increase in other income recognized under an Australian government tax incentive scheme introduced July 1, 2011. Loss before income tax expense was AUD 13,329,239 compared to AUD 7,787,242 a year ago. Diluted loss per share was 3.11 cents compared to 2.30 cents a year ago. Net operating cash out flows were AUD 13,788,974 compared to AUD 7,951,254 a year ago. Payment for purchases of plant and equipment was AUD 23,047 compared to AUD 22,000 a year ago. Net Tangible Assets per Share was 7.71 cents compared to 3.66 cents a year ago.
Prana Biotechnology Limited Reports Consolidated Earnings Results for the Quarter Ended June 30, 2014
Aug 4 14
Prana Biotechnology Limited reported consolidated earnings results for the quarter ended June 30, 2014. Revenue was $93,135,000 compared to $131,863,000 a year ago. Loss from operating activities were $2,124,000 compared to income from operating activities was $2,270,000 a year ago. Loss before tax was $2,957,000 compared to profit before tax of $1,507,000 a year ago. Loss attributable to owners of the company was $4,432,000 compared to profit attributable to owners of the company of $607,000 a year ago. Net cash generated from operating activities was $5,932,000 compared to $14,923,000 a year ago. Purchase of property, plant and equipment amounted to $703,000 compared to $1,078,000 a year ago. Basic and diluted loss per share was 0.37 cents compared to basic and diluted EPS of 0.05 cents a year ago. The contraction in revenue was due to a slowdown in private construction activities, following the introduction of cooling measures to the private residential property sector. The effect of such measures was adversely felt by the construction sector in Singapore which has led to dampened construction demand.
Prana Biotechnology Limited Announces Joining of Ira Shoulson to the Board of Directors as Non Executive Director
May 13 14
Prana Biotechnology Limited announced joining of Ira Shoulson to it's board of directors as a non-executive director effective immediately. Professor Shoulson is one of the experts in neurodegenerative diseases and movement disorders, and the founder of international academic consortia the Huntington Study Group and Parkinson Study Group. and Medicine (PRSM). He is also principal investigator of the Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI). Professor Shoulson has served as a consultant to, and member of, several FDA advisory committees over the past three decades, and has been involved in eight successful new drug applications to the FDA. Prior to taking up his position with Prana, Professor Shoulson concluded his elected term as Chair and President of the Huntington Study Group.
Prana Biotechnology Limited - Special Call
Mar 31 14
To discuss the results of the 12-month Phase II Imaging trial in Alzheimer's disease