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Transition Therapeutics' Alzheimer's drug gets FDA fast-track status
July 17, 2013 / 10:52 PM / 4 years ago

Transition Therapeutics' Alzheimer's drug gets FDA fast-track status

(Reuters) - Canadian biopharmaceutical company Transition Therapeutics said the U.S. Food and Drug Administration granted a fast-track status to its Alzheimer's drug, sending its U.S.-listed shares up 33 percent in post-market trading.

A fast track designation by the FDA expedites regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs.

The drug, ELND005, currently being tested in a mid-stage trial, treats neuropsychiatric symptoms such as agitation or aggression in Alzheimer's disease.

Transition Therapeutics said the drug appeared to decrease the emergence and severity of specific neuropsychiatric symptoms in a previous mid-stage study.

About 90 percent of Alzheimer's patients develop neuropsychiatric symptoms and up to 60 percent develop agitation over the course of their disease, the company said.

Ireland-based Elan Corp Plc is Transition's marketing and development partner.

Transition Therapeutics' Toronto-listed shares closed at C$3.15 on Wednesday.

Reporting by Krithika Krishnamurthy in Bangalore; Editing by Sriraj Kalluvila

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