United States

Prana Biotechnology Ltd (PRAN.O)

PRAN.O on Consolidated Issue listed on NASDAQ Capital Market

30 Nov 2016
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Latest Key Developments (Source: Significant Developments)

Prana Biotechnology Ltd announces that European Commission approves PBT2 orphan designation for Huntington's disease
Sunday, 31 May 2015 07:40pm EDT 

Prana Biotechnology Ltd:Says that the European Commission has approved orphan designation for PBT2 for treatment of Huntington's disease, stating that Prana has shown that PBT2 might be of significant benefit for patients with Huntington's disease.Says that approval was based on recommendation of positive opinion from European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP).  Full Article

Prana Biotechnology's PBT2 recommended for orphan designation in Europe
Monday, 27 Apr 2015 08:21pm EDT 

Prana Biotechnology:Says European Medicines Agency's Committee for Orphan Medicinal Products (COMP) has adopted positive opinion recommending designation of PBT2 for treatment of Huntington disease as orphan medicinal product to European Commission (EC).Says that following finalisation of relevant documents European Medicines Agency forwards opinion to EC for its decision on designation.  Full Article

Prana Biotechnology Limited updates on FDA end-of-phase 2 status
Thursday, 12 Feb 2015 09:00pm EST 

Prana Biotechnology Limited:Announced the status of its End-of-Phase 2 discussions with the US Food and Drug Administration.At the End-of-Phase 2 meeting for its Reach2HD clinical trial and following subsequent correspondence Prana presented its plans and information package to initiate a Phase 3 trial in Huntington Disease.Upon review, the FDA has issued a Partial Clinical Hold letter based on non-clinical (animal) findings which currently limits the dose of PBT2 that can be given to patients with Huntington disease.Under Prana’s open Investigational New Drug application it is able to continue clinical trials, but at a dose that is not considered clinically relevant by the Company.The FDA has provided Prana with options to remove the Partial Clinical Hold.To support moving forward with clinical trials of PBT2 at a clinically relevant dosage in humans, Prana would conduct additional animal neurotoxicity studies or identify a strategy for safely using a clinically relevant dosage in humans in the planned Phase 3 trial in Huntington disease.The FDA has not raised any concerns about PBT2 safety data in human trials conducted to date.  Full Article

BRIEF-Prana Biotechnology Ltd provides regulatory update for PBT2

* Prana Biotechnology Ltd - further advice from US Food and Drug Administration (FDA) on steps necessary to remove Partial Clinical Hold (PCH) on PBT2