prana biotechnology ltd (PRNAF) Key Developments
Prana Biotechnology Limited Reports Consolidated Earnings Results for the Full Year Ended June 30, 2015
Aug 26 15
Prana Biotechnology Limited reported consolidated earnings results for the full year ended June 30, 2015. For the year, the company reported revenue from ordinary activities was $176,842 against $363,775 a year ago. Loss before income tax expense was $5,885,069 against $13,329,239 a year ago. Loss for the period was $5,885,069 or 1.17 cents diluted per share against $13,329,239 or 3.11 cents diluted per share a year ago. Net operating cash flows were $10,871,074 against $13,536,223 a year ago. Payments for purchases of plant and equipment were $28,757 against $23,048 a year ago.
Prana Biotechnology Limited Reports Consolidated Cash Flows for the Fourth Quarter and Year Ended June 30, 2015
Jul 27 15
Prana Biotechnology Limited reported consolidated cash flows for the fourth quarter and year ended June 30, 2015. For the quarter, the company’s net operating cash flows was AUD 1,938,000. Payment for acquisition of physical non-current assets was AUD 4,000.
For the year, the company’s net operating cash flows used in was AUD 10,845,000. Payment for acquisition of physical non-current assets was AUD 30,000.
Prana Biotechnology Announces Safety Outcomes of Alzheimer's IMAGINE Extension Trial
Jun 30 15
Prana Biotechnology announced the safety outcomes of the IMAGINE Extension study in patients with Alzheimer's disease. A 250mg dose of PBT2 was safe and well tolerated over a 2 year period. The independent Data Safety Monitoring Board did not identify any safety concerns related to PBT2. The IMAGINE Extension Study allowed all 40 participants who completed the original 12 month IMAGINE trial to receive PBT2 for a further 12 months. In all, 33 out of the 40 eligible IMAGINE patients elected to continue onto the Extension study. It was an Open Label study, with all participants taking PBT2. A total of 27 patients completed the Extension Study. Clinical and scientific experts are reviewing the effects of PBT2 taken for 2 years. Whilst there is no placebo group to compare to within the Extension Study, the experts are very interested in better understanding how treatment with PBT2 would differ from the anticipated outcome without treatment. The safety data will form part of the package presented to the FDA as part of goal to remove the Partial Clinical Hold on PBT2 in the US. Prana will continue to work with the US Food and Drug Administration and other agencies to initiate a Phase 3 trial for PBT2 to treat Huntington disease. PBT2 for the treatment of Huntington disease was recently granted Orphan designation in Europe and was granted Orphan designation in the US in 2014.
Prana Biotechnology Limited Announces the European Commission Approves the Orphan Designation for PBT2 for the Treatment of Huntington's Disease
Jun 1 15
Prana Biotechnology Limited announced that the European Commission has approved orphan designation for PBT2 for the treatment of Huntington's disease, stating that Prana has shown that PBT2 might be of significant benefit for patients with Huntington's disease. The approval was based on the recommendation of a positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP). The COMP assessed the scientific documentation for PBT2 against the key criteria for orphan designation. The criteria require that PBT2 be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; have a prevalence in the EU not more than five in 10,000, and no satisfactory method of diagnosis, prevention or treatment of the condition concerned, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Orphan designation provides for ten years of market exclusivity in the European Union (EU) from the granting of a marketing authorization (approval for sale). Other benefits relate to assistance in developing clinical protocols, reduced fees, and access to EU-funded research grants.
Prana Biotechnology Limited Reports Consolidated Cash Flow Results for the Third Quarter and Nine Months Ended March 31, 2015
Apr 28 15
Prana Biotechnology Limited reported consolidated cash flow results for the third quarter and nine months ended March 31, 2015. For the quarter, the company reported net operating cash flows (carried forward) of AUD 4,360,000 and payment for acquisition of physical non-current assets of AUD 4,000.
For the nine months, the company reported net operating cash flows (carried forward) of AUD 12,783,000 and payment for acquisition of physical non-current assets of AUD 26,000.