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)